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Material Planner Job (clayton, NC, US)

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Requisition ID 18293BR
Title Material Planner
Job Category Supply Chain and Logistics
Job Description Position Purpose:
•Ensure material availability for production; optimize material inventories; continuously improve Logistic processes

Education:
BS/BA in Supply Chain Management, Business or related field.

Experience:
3 or more years of experience in planning /purchasing or related field; or combination of relevant education and experience

Technical/Process/Functional Knowledge:
Excellent verbal and written communication skills; good presentation skills
Computer skills including experience with Excel and electronic Material management systems.
Familiarity with SAP
Proven process improvement and problem solving skills
Willing to learn LEAN and Flow concepts and skills

Physical Requirements: Other Requirements:
Majority of time in normal work environment . Requires flexibility to work whatever hours are required to meet deadlines and targets supporting 24/7 operations. Eligible for passport; Some travel overseas required
Service attitude: Demonstrates a “How can I help you today!” attitude

Department Purchasing
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

QC Technician I - Environmental Monitori (12 hr days +every other wkd) Job (clayton, NC, US)

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Requisition ID 18294BR
Title QC Technician I - Environmental Monitori (12 hr days +every other wkd)
Job Category Quality
Job Description Position Purpose:
Performs routine sanitization of the Aseptic Processing area and collects facility air, surface, personnel monitoring and water samples in support of facility environmental procedures and in accordance with cGMP, NNPII and corporate policies.

Education: High school graduate or equivalent, AAS degree in related field preferred.
BioWorks graduate.

Experience: Minimum of 1 years experience in a manufacturing industry, FDA regulated preferred.

Technical/Process/Functional Knowledge: Ability to read, write and understand complicated product documentation and standard operating procedures with attention to detail. Computer literacy.
Organization/Planning: Proven expertise in planning/organizing, managing execution, checking results, and revising the work plan in accordance with the daily work plan

Physical Requirements:
Ability to lift up to 30 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to attain clean room gowning certification and work with hazardous materials including sanitants.
Frequent bending, stooping, and prolonged working overhead Ability to work hours necessary to support production.
Ability to stand on feet up to 12 hours or longer, day or night.
Corrected vision to 20/30
Ability to work in loud noise environments with hearing protection

Department QC - Environmental Monitoring
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Associate's Degree or equivalent experience
Shift Day

Pharma Field Sales - Diabetes Care Specialist (DCS) Raleigh N, NC Job (RALEIGH, NC, US)

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Requisition ID 18113BR
Title Pharma Field Sales - Diabetes Care Specialist (DCS) Raleigh N, NC
Job Category Sales
Job Description Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

Pharma Field Sales - Diabetes Care Specialist (DCS) Raleigh N, NC

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 15% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - RALEIGH-DURHAM NC
Position Location US - Field Based - Across US
City RALEIGH
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-Diabetes Care Specialist (DCS)-Washington, PA Job (WASHINGTON, PA, US)

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Requisition ID 17706BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Washington, PA
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Washington, PA

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - SOUTH PITTSBURGH PA
Position Location US - Field Based - Across US
City WASHINGTON
State/Provinces US - PA
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-Diabetes Care Specialist (DCS)-Torrington, CT Job (TORRINGTON, CT, US)

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Requisition ID 18117BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Torrington, CT
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Torrington, CT

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - WATERBURY CT
Position Location US - Field Based - Across US
City TORRINGTON
State/Provinces US - CT
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-District Business Manager(DBM)-Waterbury, CT Job (Waterbury, CT, US)

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Requisition ID 17441BR
Title Pharma Field Sales-District Business Manager(DBM)-Waterbury, CT
Job Category Field Sales
Job Description Pharma Field Sales - District Business Manager (DBM)-Waterbury, CT

PURPOSE:
To develop and lead sales teams in the execution of sales strategies that increase profitability to maximize sales objectives. Works with RBD to manage, train, develop staff, and prepare regional budget and business plans. This is an entry level district business manager position.

RELATIONSHIPS:
Reports to the Regional Business Director. Manages a region’s sales force, and has direct supervisory responsibility for Pharmaceutical Sales Representatives. Works closely with RBD, peers and the home office to achieve sales objectives and to ensure the development of people. Other relationships include physicians, key accounts, co-promotion partners, associations, field and home office personnel.

PRINCIPAL ACCOUNTABILITIES:

BUSINESS PLANNING
•Work to develop a full understanding of the content and then execute the regional business plan to achieve the fulfillment of Plan objectives/requirements. This includes delivery-of-care system delineation, account targeting, needs assessment, and program implementation.
•Execute regional level account targeting strategy in business unit to fulfill regional account targeting strategy requirements.
•Manage business unit customer needs assessment. Apply assessment frameworks against accounts in region by overseeing DCS account assessment activities. Identify program/service requirements for addressing needs. Work with the VP Diabetes Sales, Field Sales, Regional Directors and appropriate home office management to feed requirements into program development (contracting, marketing programs).
•Oversee regional account relationship development/management. Manage critical regional account relationships and set account relationship development objectives for regional staff.
•Manage regional resource allocation.
•Monitor regional program/initiative effectiveness.
•Monitor performance against strategic account management objectives/directives.

COORDINATION/PARTNERSHIP
•Ensure contractual requirements are met for the region (# of physician calls per day).
•Work with RBD, DBMs, home office and CSO counterparts to gain insight into programs and initiatives.
•Gain an understanding of regional level coordination between field resources, intra-organization resources and inter-organizational resources. Work with RBD to incorporate district.
•Ensure appropriate level of coordination to attain regional business plan objectives.

ADMINISTRATION
•Communicate Regional activity of competitive products through timely submission of monthly highlight reports as directed.
•Review and audit expense reports.
•Evaluate appropriate use of regional resources to ensure attainment of profitability goals.
•Develop and monitor performance against regional budgets.
•Establish and oversee regional implementation, and monitor adherence to administrative policies and procedures.
•Ensure timely and accurate submission of administrative requirements.

ADHERE TO AND SUPPORT COMPANY POLICIES, PROCEDURES AND SALES/MARKETING DIRECTION. IMPLEMENT COMPANY POLICIES, PROCEDURES AND SALES/MARKETING DIRECTION THROUGHOUT THE RBU
•Monitor and reinforce the use of the Sales Force Automation System.
•Ensure timely and accurate transmission of DCS call data.
•Adhere to the Prescription Drug Marketing Act of 1987 and all related Novo Nordisk policies regarding the judicious use of physician samples and stock items.

DEVELOPMENT OF PEOPLE/MANAGEMENT
•Fill open territories with high quality talent within 6 weeks.
•Ensure that reporting personnel have Performance Achievement Plans with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
•Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
•Ensure that development and training plans are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
ATTAIN AND MAINTAIN PROFICIENT LEVELS OF NNPI AND COMPETITIVE PRODUCT KNOWLEDGE
•Continuously improve the knowledge of Novo Nordisk products, competitive products, and management skills through ongoing home study and participation in company sponsored/approved training programs.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• At least 5 Years Progressive Pharmaceutical/Healthcare Sales experience required
• 2 Years Previous Supervisory experience preferred
• Bachelor Degree required from College or University accredited by an organization recognized by the US Department of Education; major in Business or Marketing preferred.
• Top 20% sales ranking for 1 out of last 2 years, documented (Regionally)

OTHER:
•Works within NNPI’s established policies and procedures and ensures alignment of their work to Novo Nordisk Fundamentals.
•Minimum of 5 years of progressive pharmaceutical/healthcare sales experience required.
•Significant record of sales accomplishments.
•Two years previous supervisory experience preferred.
Department SALES - WATERBURY CT
Position Location US - Field Based - Across US
City Waterbury
State/Provinces US - CT
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%

Kvalitetsorienteret ingeniør til optimering af lagerprocesser (Kalundborg, Danmark)

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Kvalitetsorienteret ingeniør til optimering af lagerprocesser

Du kan lære mere om Novo Nordisk�s største produktionssite ved at bruge www.novonordisk.com/kalundborg-careers

- Produktion
- Danmark - Kalundborg

Vil du være med til at opbygge Warehouse support funktionen og være en nøgleperson i at sikre en optimeret integration af GMP krav i vores lagerprocesser? Er du samtidig stærk til at forstå komplekse processer og har du flair for at sikre at kvaliteten af processerne er dokumenteret i vores kvalitetssystem så er det dig vi har brug for.

Om afdelingen
I bygning DF i Kalundborg monteres og pakkes en stor mængde af de diabetesprodukter som Novo Nordisk producerer og leverer til markedet. Afdeling 070 håndterer IT, Warehouse og Facility i bygning DF og har fokus på at understøtte den positive udvikling som bygning DF har gennemgået med øget produktionsvolumen til flere linjer af diabetesprodukter og etablering af BioPharmaceuticals produktion i bygningen. En forudsætning for at processerne i og omkring produktionen fungerer succesfuldt er lagerfunktionen, som er en del af IT, Warehouse og Facility afdelingen. Lageret håndterer en stor mængde ind- og udgående processer dagligt for at sikre, at produktionen kører optimalt og med minimale driftsstop til følge.

Om jobbet
Du bliver en del af den nyetablerede Warehouse support funktion, der sikrer support til lageret og den øvrige bygning. Du får ansvar for at sikre compliance og supportere driftsorganisationen på lageret, således at processer optimeres/dokumenteres og kvalitet forankres som en integreret del af processerne. Dette er afgørende for, at vi kan fylde og pakke færdigvarer på vores højeffektive fabrik.

Du og dine kolleger i teamet skal sørge for, at vores lager fungerer optimalt, efterlever gældende retningslinjer og lever op til Novo Nordisks strenge kvalitetskrav. Dette sikrer du ved at skabe struktur og overblik gennem et analytisk og detaljeret dokumentationsarbejde. Du faciliterer problemløsninger, gennemskuer komplekse problemstillinger og processer og omsætter dette til værdifuld sparring med dine kolleger i afdelingen. Endeligt gennemfører du ændringssager, håndterer afvigelser, indgår i projektarbejde og yder generel GMP support og sparring.

Kvalifikationer
Du er uddannet ingeniør, farmaceut eller har en anden højere naturvidenskabelig uddannelse med flere års erfaring indenfor lager eller logistikprocesser. Du har optimalt set kendskab til GMP og ved hvad dokumentation betyder for kvalitetsarbejde. Alternativt har du interessen for at forstå og arbejde med GMP krav og mindset. Du trives godt i et til tider hektisk miljø, hvor vi har fokus på at hjælpe hinanden på tværs. Du er udadvendt og har lyst til at interagere med alle medarbejdergrupper. Alt dette for at sikre, at de gode løsninger du sammen med teamet finder frem til forankres hos medarbejderne på lageret.

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der hjælper os med at forbedre mange menneskers liv. Til gengæld tilbyder vi dig muligheden for at arbejde sammen med usædvanligt talentfulde kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

Kontakt
Vil du vide mere om stillingen, så kontakt Thomas Algot Søllested på tlf. +45 3079 7725. Ansøgninger vil blive vurderet løbende.

Ansøgningsfrist
2. december 2013

Pharma Field Sales - Diabetes Care Specialist (DCS) Richmond W, VA Job (Richmond, VA, US)

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Requisition ID 18195BR
Title Pharma Field Sales - Diabetes Care Specialist (DCS) Richmond W, VA
Job Category Sales
Job Description Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

Pharma Field Sales - Diabetes Care Specialist (DCS) Richmond W, VA

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 15% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - RICHMOND VA
Position Location US - Field Based - Across US
City Richmond
State/Provinces US - VA
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-Diabetes Care Specialist (DCS)-Reston, VA Job (Reston, VA, US)

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Requisition ID 17205BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Reston, VA
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Reston, VA

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - CENTRAL VIRGINIA
Position Location US - Field Based - Across US
City Reston
State/Provinces US - VA
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales - District Business Manager (DBM)-Hershey, PA Job (Hershey, PA, US)

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Requisition ID 17481BR
Title Pharma Field Sales - District Business Manager (DBM)-Hershey, PA
Job Category Field Sales
Job Description Pharma Field Sales - District Business Manager (DBM)-Hershey, PA

PURPOSE:
To develop and lead sales teams in the execution of sales strategies that increase profitability to maximize sales objectives. Works with RBD to manage, train, develop staff, and prepare regional budget and business plans. This is an entry level district business manager position.

RELATIONSHIPS:
Reports to the Regional Business Director. Manages a region’s sales force, and has direct supervisory responsibility for Pharmaceutical Sales Representatives. Works closely with RBD, peers and the home office to achieve sales objectives and to ensure the development of people. Other relationships include physicians, key accounts, co-promotion partners, associations, field and home office personnel.

PRINCIPAL ACCOUNTABILITIES:

BUSINESS PLANNING
•Work to develop a full understanding of the content and then execute the regional business plan to achieve the fulfillment of Plan objectives/requirements. This includes delivery-of-care system delineation, account targeting, needs assessment, and program implementation.
•Execute regional level account targeting strategy in business unit to fulfill regional account targeting strategy requirements.
•Manage business unit customer needs assessment. Apply assessment frameworks against accounts in region by overseeing DCS account assessment activities. Identify program/service requirements for addressing needs. Work with the VP Diabetes Sales, Field Sales, Regional Directors and appropriate home office management to feed requirements into program development (contracting, marketing programs).
•Oversee regional account relationship development/management. Manage critical regional account relationships and set account relationship development objectives for regional staff.
•Manage regional resource allocation.
•Monitor regional program/initiative effectiveness.
•Monitor performance against strategic account management objectives/directives.

COORDINATION/PARTNERSHIP
•Ensure contractual requirements are met for the region (# of physician calls per day).
•Work with RBD, DBMs, home office and CSO counterparts to gain insight into programs and initiatives.
•Gain an understanding of regional level coordination between field resources, intra-organization resources and inter-organizational resources. Work with RBD to incorporate district.
•Ensure appropriate level of coordination to attain regional business plan objectives.

ADMINISTRATION
•Communicate Regional activity of competitive products through timely submission of monthly highlight reports as directed.
•Review and audit expense reports.
•Evaluate appropriate use of regional resources to ensure attainment of profitability goals.
•Develop and monitor performance against regional budgets.
•Establish and oversee regional implementation, and monitor adherence to administrative policies and procedures.
•Ensure timely and accurate submission of administrative requirements.

ADHERE TO AND SUPPORT COMPANY POLICIES, PROCEDURES AND SALES/MARKETING DIRECTION. IMPLEMENT COMPANY POLICIES, PROCEDURES AND SALES/MARKETING DIRECTION THROUGHOUT THE RBU
•Monitor and reinforce the use of the Sales Force Automation System.
•Ensure timely and accurate transmission of DCS call data.
•Adhere to the Prescription Drug Marketing Act of 1987 and all related Novo Nordisk policies regarding the judicious use of physician samples and stock items.

DEVELOPMENT OF PEOPLE/MANAGEMENT
•Fill open territories with high quality talent within 6 weeks.
•Ensure that reporting personnel have Performance Achievement Plans with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
•Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management.
•Ensure that development and training plans are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
ATTAIN AND MAINTAIN PROFICIENT LEVELS OF NNPI AND COMPETITIVE PRODUCT KNOWLEDGE
•Continuously improve the knowledge of Novo Nordisk products, competitive products, and management skills through ongoing home study and participation in company sponsored/approved training programs.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• At least 5 Years Progressive Pharmaceutical/Healthcare Sales experience required
• 2 Years Previous Supervisory experience preferred
• Bachelor Degree required from College or University accredited by an organization recognized by the US Department of Education; major in Business or Marketing preferred.
• Top 20% sales ranking for 1 out of last 2 years, documented (Regionally)

OTHER:
•Works within NNPI’s established policies and procedures and ensures alignment of their work to Novo Nordisk Fundamentals.
•Minimum of 5 years of progressive pharmaceutical/healthcare sales experience required.
•Significant record of sales accomplishments.
•Two years previous supervisory experience preferred.
Department SALES - HERSHEY PA
Position Location US - Field Based - Across US
City Hershey
State/Provinces US - PA
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%

Pharma Field Sales-Diabetes Care Specialist (DCS)-New Haven, CT Job (NEW HAVEN, CT, US)

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Requisition ID 18068BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-New Haven, CT
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - New Haven, CT

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - FAIRFIELD CT
Position Location US - Field Based - Across US
City NEW HAVEN
State/Provinces US - CT
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-Diabetes Care Specialist (DCS)-Great Neck, NY Job (GREAT NECK, NY, US)

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Requisition ID 18077BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Great Neck, NY
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Great Neck, NY

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - LONG ISLAND WEST NY
Position Location US - Field Based - Across US
City GREAT NECK
State/Provinces US - NY
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-Diabetes Care Specialist (DCS)-Great Neck, NY Job (Great Neck, NY, US)

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Requisition ID 18202BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Great Neck, NY
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Great Neck, NY

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - LONG ISLAND WEST NY
Position Location US - Field Based - Across US
City Great Neck
State/Provinces US - NY
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-Diabetes Care Specialist (DCS)-Somerville, NJ Job (Somerville, NJ, US)

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Requisition ID 18186BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Somerville, NJ
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Somerville, NJ

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - CENTRAL JERSEY NJ
Position Location US - Field Based - Across US
City Somerville
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Pharma Field Sales-Diabetes Care Specialist (DCS)-Somerville, NJ Job (Somerville, NJ, US)

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Requisition ID 17204BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Somerville, NJ
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Somerville, NJ

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - CENTRAL JERSEY NJ
Position Location US - Field Based - Across US
City Somerville
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

QC Microbiologist I Job (clayton, NC, US)

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Requisition ID 18290BR
Title QC Microbiologist I
Job Category Quality
Job Description Position Purpose:
Perform and review analysis of in process and filled product in accordance with cGMP, site and corporate procedures and policies.

Education: BS/BA in microbiology, biological sciences, or related field of study.

Experience:
Minimum 1 yr. experience in a clinical or industrial/pharmaceutical microbiology laboratory.
Environmental monitoring experience preferred.
Isolator experience preferred

Technical/Process/Functional Knowledge:
Knowledgeable in the following: Microbiological testing, GMPs and laboratory techniques. In addition, strong communication skills (verbal and written) and the ability to author scientific and technical reports.
Able to perform Sterility, Bacterial Endotoxin testing and Microbial Identification. Basic troubleshooting for laboratory equipment. Must demonstrate attention to detail, proofreading and strong computer skills with a willingness to learn new IT applications.

Physical Requirements: Other Requirements:
Able to work with hazardous materials and chemicals.
Corrected vision to 20/30 , Able to lift 25 Lbs. with assistance
Able to work extended hours to support manufacturing operations.

Department QC Microbiology
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required

Pharma Field Sales-Diabetes Care Specialist (DCS)-Charleston, WV Job (Charleston, WV, US)

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Requisition ID 18203BR
Title Pharma Field Sales-Diabetes Care Specialist (DCS)-Charleston, WV
Job Category Field Sales
Job Description Pharma Field Sales - Diabetes Care Specialist (DCS) - Charleston, WV

Novo Nordisk is a focused healthcare company and a world leader in diabetes care. We are actively working to change the course of the diabetes pandemic, improve the daily lives of people with diabetes, and to expand the possibilities for people with hemophilia.

This position represents Novo Nordisk within an assigned territory with the goal of maximizing sales and positioning Novo Nordisk as the leading company in diabetes care. The DCS must assume responsibility for achieving sales goals by implementing marketing and sales strategies aimed at effectively selling and promoting Novo Nordisk’s portfolio of diabetes products to physicians, pharmacists, nurses, and other paramedical customers and current co-promotion partners who make or are involved in purchasing and prescribing decisions. This position also determines and recommends the most appropriate Novo Nordisk product and approved usage for the needs of the customers.

The DCS reports to the District Business Manager of the specific sales territory and interacts regularly with territory partners. The DCS sells and promotes Novo Nordisk’s portfolio of diabetes products with a focus on targeted and non-targeted primary care physicians, pharmacists, nurses, and other members of patients’ primary care team.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
•At least one year pharmaceutical sales experience OR at least one year business-to-business (B2B) sales required.
•Bachelor’s Degree from college or university accredited by an organization recognized by the US Department of Education required. Advanced degree preferred.
•Top 20% sales ranking for 1 out of last 2 years in a sales role, documented (regionally or nationally) or equivalent documentation for B2B candidates
•Proven leadership and decision-making ability.
•Solid understanding of diabetes disease state and Novo Nordisk’s products, coupled with aptitude for learning and ability to communicate technical and scientific product and disease management information.
•Must have a consistent proven track record of winning sales results
•Must be a self-starter and be able to evaluate options and make decisions with minimal supervision.
•Intermediate computer skills required (Windows, Word, Excel)
•Prior computer experience using sales data/call reporting software ideal
•Must maintain a valid driver’s license and obey all applicable traffic laws.
•Approximately 10% overnight travel

A winning attitude and passion for making a real difference in the lives of our patients ensures the right fit for you and the team at Novo Nordisk. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing information to physicians and customers. Our Sales professionals ensure that the latest therapies and products reach the people who need them most, by listening to their needs and advocating for even greater enhancements.
Department SALES - CENTRAL WEST VIRGINIA WV
Position Location US - Field Based - Across US
City Charleston
State/Provinces US - WV
Degree Required Bachelor's Degree Required
Percent Travel 0 - 10%

Regional Clinical Research Associate (CRA)- Norfolk, VA Job (Norfolk, VA, US)

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Requisition ID 18064BR
Title Regional Clinical Research Associate (CRA)- Norfolk, VA
Job Category Clinical
Job Description PURPOSE:
Responsible for performing study activities regarding the implementation, monitoring and summarization of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR.

RELATIONSHIPS:
Reports to a Manager/Senior Manager/Associate Director of Field Management (FM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.

ESSENTIAL FUNCTIONS:

COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.

FUNCTIONAL SUPPORT:
- May participate in continuous improvement processes for function.

PROJECT SUPPORT:
- Act as primary liaison for assigned study sites while on-site to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation. Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
- Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
- Attends Investigator Meetings and study-specific training for assigned trials.
- Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate.
- Collaborates with the Lead CRA(s) to obtain/share trial specifics issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and CRAs as appropriate.
- Completes follow up letters from all visit types according to SOPs and completes reports to quality standards within company specified timelines.
- Completes Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and completes reports to quality standards within company specified timelines.
- Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
- Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites.
- Performs on-site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.
- Responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines while on site.
- Responsible for assuring adequate and appropriate dissemination of information according to the study specific communication plan between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.

STAFF DEVELOPMENT:
- May provide active mentorship of CTM staff to build talent across the department.
- May support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.

TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams.
- Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration, IVRS and updates, and ensure CSIM entries and updates are made.
- Responsible for maintaining focus, locally, for specific project activities within CMR priorities.
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.

PHYSICAL REQUIREMENTS:
- Approximately 70% overnight travel to visit assigned sites for monitoring and attending trainings/meetings.
- Must live within 50 miles of the regional workload center within assigned region.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (science-related discipline preferred) with a minimum of 4 years’ clinical trial experience within the pharmaceutical and/or healthcare setting, of which at least 2 years has been in the role of an on-site monitoring CRA, OR a Registered Nurse (RN) with a minimum of 5 years on-site monitoring experience.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - FIELD MGMT NORTHEAST (1)
Position Location US - Field Based - Across US
City Norfolk
State/Provinces US - VA
Degree Required Bachelor's Degree Required
Percent Travel 70 - 80%

In-House Clinical Research Associate (CRA) Job (Princeton, NH, US)

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Requisition ID 18237BR
Title In-House Clinical Research Associate (CRA)
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR. May be responsible for monitoring assigned sites in accordance with GCP/ICH and NNI SOPs.

RELATIONSHIPS:
Reports to a Manager/Senior Manager/Associate Director of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.

ESSENTIAL FUNCTIONS:

COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.

FUNCTIONAL SUPPORT:
May participate in continuous improvement processes for function.

PROJECT SUPPORT:
- Accountable for the setup, quality and maintenance of the electronic Trial Master
Files (TMF) in accordance with NNI SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide develop regulatory documentation to support study start up
activities, including all site supplies.
- Act as primary liaison for assigned study sites to convey project information, answer
questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues.
- Arranges for certified translation of study documentation as appropriate.
- Assists the project team in preparation for audits/inspections and is responsible for the
quality and completeness of in-house documentation.
- Attains thorough understanding of study management tasks and responsibilities
necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
- Collaborates with the Lead CRA(s) to obtain/share trial specifics issues across all
study sites concentrating on areas related to quality, site performance and metrics. - Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and CRAs as appropriate.
- Ensure all regulatory documents and study supplies are maintained during the
lifecycle of any assigned project in collaboration with the assigned CRA.
- Liaises with Clinical Budget Management to secure confidentiality agreements, master
services agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval.
- Preparation and review of various study related tracking systems to determine and
report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc.) and responsible for the follow up to collect outstanding documents.
- Provides quality overview and consistency check on all developed ICFs and
completes the informed consent checklist.
- Responsible for the submission and correction of regulatory green light packages to
the Quality Management Group within CTM for approval.
- Responsible for assuring adequate and appropriate dissemination of information
according to the study specific communication plan between sites, in house and regionally based staff to ensure project success.
- Responsible for coordinating and securing IRB approval (local and central).
- Responsible for providing step by step guidance and partnership with sites to secure IRB approval.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure
quality and deliverables are met across assigned sites.

STAFF DEVELOPMENT:
- May provide active mentorship of CTM staff to build talent across the department.
- May support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.

TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams, contributor to Clinical Team Unit (CTU) Meetings.
- Participates in cross-functional teams, locally, to assure timely attainment of project
milestones.
- Responsible for conducting oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible for ensuring that the mandatory trial entries are made in IMPACT,
NovoDOCs, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible for maintaining focus, locally, for specific project activities within CMR
priorities.

TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.

PHYSICAL REQUIREMENTS:
- Approximately 20% overnight travel to visit assigned sites for monitoring and/or trainings office.
- Based in Princeton, NJ.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree required (science-related discipline strongly preferred).
- A minimum of 5 years of clinical trial experience within pharmaceutical, biotechnology, CRO company and/or healthcare setting.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Direct expertise of site management and logistical execution of clinical trials for at least 2 years.
- Knowledge of GCP as relates to clinical trial management.
- Previous on-site monitoring experience preferred.
Department CMR - SITE MANAGEMENT (1b)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NH
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%

Supporter til IM2 Fermentation Support, Kalundborg (Kalundborg, Danmark)

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Supporter til IM2 Fermentation Support, Kalundborg

Du kan lære mere om Novo Nordisk�s største produktionssite ved at bruge www.novonordisk.com/kalundborg-careers

- Produktion
- Danmark - Kalundborg

Brænder du for et job i et travlt produktionsmiljø med ansvar for frigivelse af produkt, udarbejdelse af instruktioner, rapporter, reviews og anden dokumentation? Kan du lide at lave problemløsning på baggrund af data, ved brug af LEANværktøjer, og trives du med at arbejde på tværs af faggrænser? Så er du måske den supporter vi søger til vores gæringssupport team.

Om afdelingen
Har du flair for dokumentation og kvalitet, og vil du være med til at sikre kvaliteten af insulinprodukter på de allerførste trin i produktionsprocessen? Så er du måske vores nye kollega i afdelingen Fermentation, hvor vi har ansvaret for både gæringsproces og produktionsudstyr. Dit team består både af tekniske supportere og kemikere, som frigiver produkter og konstant overvåger procesafvikling, gæringstanke og de fysiske anlæg i fabrikken – Insulin Manufacturing II (IM2) i Kalundborg. Glæd dig til et job, hvor du er med til at gøre en forskel for produktionen af bl.a. human insulin og moderne insuliner.

Jobbet
Sammen med teamet får du ansvaret for at sikre, at produktkvaliteten er i orden i henhold til gældende myndighedskrav. Din primære opgave bliver at frigive produkt via review af batchrapporter og sikring af at al frigivelsesberørt dokumentation er lukket før produktet kan sendes videre til finrensningsfabrikkerne. Ligeledes skal du lejlighedsvist udarbejde SOPs, e-logs og afvigelsesrapporter. Vi arbejder indgående med Lean, og på vores daglige tavlemøder bidrager du med ideer til at sætte struktur på vores problemløsning og igangsætte f.eks. workshops. Du kan se frem til en stilling med fokus på administrativt arbejde, hvor du får rig mulighed for at udvikle dine personlige kompetencer og sætte dit præg på samarbejdet i afdelingen.

Kvalifikationer
Din baggrund er en relevant teknisk uddannelse og gerne erfaring fra kemisk, farmaceutisk eller fødevareproduktion. Du har god forståelse for samspillet mellem proces og udstyr og kendskab til GMP eller et lignende kvalitetssystem. Med andre ord er du yderst kvalitetsbevidst, og har du erfaring med optimering af administrative processer, er det en fordel. Dine kolleger eller studiekammerater kender dig som en engageret og positiv person, der er meget bevidst om sit ansvar. Du kan både arbejde selvstændigt og indgå i tæt samarbejde – også selvom det er på tværs af team og faggrænser. Endelig interesserer du dig for Lean, og du er positivt indstillet over for forandringer, da du er god til at se muligheder frem for begrænsninger. Stillingen bliver i høj grad administrativ og orienteret imod udarbejdelse af dokumentation og involvering i de frigivelsesprocesser, som ligger til grund for at vores gæringsvæske kan sendes videre til oprensningstrinene i finsrensningsfabrikkerne.

I Novo Nordisk stræber vi efter at være de bedste. Vi er førende i verden indenfor diabetesbehandling og en større spiller indenfor behandling af blødninger, behandling med væksthormon og behandling med hormonterapi. Derfor kan vi tilbyde vores medarbejdere mulighed for en stærk professionel udvikling.

Kontakt
Vil du vide mere om stillingen så kontakt Ane Christensen på +45 3075 5478.

Ansøgningsfrist
10. december 2013
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