Requisition ID 43150BR<br/>Title Industry Practice Fellowship- Regulatory Review (PharmD)<br/>Job Category Fellowships<br/>Job Description As part of this 1 year fellowship, the fellow will gain experience in Regulatory Affairs Promotional Review, learning about compliance with internal policies and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. As fundamentals are established, the fellow will review advertising and promotional materials and participate in Promotional Review Board meetings. The fellow will be selected on a nationally competitive basis.<br/><br/>The Postdoctoral Industry Practice Fellowship is a one-year, experiential program based in Plainsboro, New Jersey. This fellowship is intended to provide experience for Doctors of Pharmacy within the pharmaceutical industry. The postdoctoral fellow will focus on Regulatory Affairs Promotional Review at Novo Nordisk Inc., where a PharmD’s training and expertise will provide value to the organization. The fellow will gain the skills needed to pursue a career within the pharmaceutical industry where their education and experience can make a significant contribution to satisfying customer needs and achieving company goals.<br/>RELATIONSHIPS:<br/>The fellow will report to their Fellowship Manager/preceptor within Regulatory Affairs – Promotional Review throughout the 12-month program. Additional key internal relationships may include other areas of Regulatory Affairs. External relationships may include interaction with FDA personnel regarding assigned projects and roles.<br/><br/>ESSENTIAL FUNCTIONS:<br/>GENERAL: All postdoctoral fellows will complete a Fellowship project for presentation. Additionally, fellows may be asked to attend other relevant scientific conventions, national team meetings and other travel as required for business needs related to fellow projects as appropriate.<br/>GENERAL: The fellow will have regular contact with cross functional areas including Medical Operations, Marketing and Market Shaping, Legal, Medical Affairs, among others. This structured approach will allow for a broad, “hands-on” experience enabling the fellows to gain the skills needed to pursue a career within the pharmaceutical industry.<br/><br/>PROMOTIONAL REVIEW: Assure company compliance with FDA and FTC requirements and strategy, including timely and accurate submission of promotional materials to FDA in Form 2253.<br/><br/>PROMOTIONAL REVIEW: Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company of these requirements. Assist in establishing procedures to assure compliance with these requirements<br/><br/>PROMOTIONAL REVIEW: Review draft and final advertising/promotional materials assuring full regulatory compliance of all promotions for all assigned products.<br/><br/>PROMOTIONAL REVIEW: Assist in development and implementation of strategy to maintain efficient and compliant PRB process.<br/><br/>PHYSICAL REQUIREMENTS: May require some overnight travel<br/><br/>KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS<br/>· A Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy with strong academic track record required<br/>* Demonstrate strong attention to detail skill, well organized, deadline oriented.<br/>* Demonstrated leadership capabilities<br/>* Possess excellent communication skills, both oral, written and presentation, and ability to engender trust and respect of peers and superiors.<br/>* Presentable, highly articulate, goal-oriented, honest, with high integrity and strong ethics.<br/><br/>* Good interpersonal skills; ability to interact with staff on all levels.<br/>* Proficiency in PowerPoint, Excel and MS word software applications and overall computer skills.<br/><br/>Department CMR - REG AFFAIRS (2a)<br/>Position Location US - Princeton, NJ<br/>City Plainsboro<br/>State/Provinces US - NJ
<br/><br/>At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
<br/><br/>With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
<br/><br/><p class="eeo_desc">Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.<br/><br/>
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.<br/><br/>
If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: <a href="https://www.surveymonkey.com/r/novoaccommodation" target="_blank" title="Accomodation Survey">https://www.surveymonkey.com/r/novoaccommodation</a>. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.</p>
↧