Requisition ID 17195BR
Title Medical Writer/ Sr. Medical Writer
Job Category Medical Information
Job Description PURPOSE:
The Medical Writer/ Sr. Medical Writer, working under the supervision of more senior SSC colleagues, is responsible for the preparation and tracking of documents that support the regulatory and publication activities for assigned NNI therapeutic areas.
RELATIONSHIPS:
This position reports to Associate Director in Strategic Scientific Communications (SSC). Internally, the Medical Writer/Sr. Medical Writer interacts with temporary help, administrators, internal medical writers, e-publishers, and other personnel at many levels within NNI, NN A/S, as well as other NN affiliates. Externally, the Medical Writer interacts with freelance/contract medical writers and agencies, investigators, journals, and colleagues in relevant professional associations.
ESSENTIAL FUNCTIONS:
ADVISORY BOARDS AND RESULTS MEETINGS:
With guidance assist, assist organizers in preparing slides and minutes
GENERAL:
Assists other medical writers, as per project timeline and workload demands.
Remains current with medical and regulatory guidelines as well as the literature in therapeutic areas.
Works within SSC to understand and implement document preparation procedures and Standard Operating Procedures (SOPs). Understands and follows regulatory, legal, and other relevant guidelines.
PUBLICATIONS:
With general direction, interacts with NNI and HQ publication teams, journals, editors, authors, and others as necessary to ensure the successful completion of manuscripts and other publication projects. Capable of managing multiple projects and tracking.
With guidance, prepares manuscripts, meeting abstracts, scientific poster presentations, and other items necessary for publication support. Has knowledge of, and follows, Good Publication Practices.
REGULATORY:
With general direction, assists and/or prepares clinical trial reports, summary documents, package inserts, and other documents that support the regulatory needs of a project.
With guidance assist Biostatistics group with preparation of Key Results Meeting (KRM) slides.
SCIENTIFIC MEETING ACTIVITIES:
With general direction, interacts with Medical Affairs, clinical Developments, HQ, and others as needed to assure that NNI interests are represented at designated US scientific meetings through abstracts, slide presentations, poster presentations, and other venues as appropriate. Assists HQ and other affiliates as needed with scientific presentations for meetings conducted outside the U.S.
Attend scientific meeting to gain knowledge and assist as required by authors and other colleagues
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A M.S. or PhD in a life science or PharmD required (A minimum of two years relevant scientific/medical/ regulatory medical writing experience required with an M.S.)
Demonstrated scientific writing (e.g., manuscripts, research grants, etc…) ability.
General understanding of statistical methods, ability to learn and understand regulatory requirements and drug development processes and regulatory requirements.
Generally proficient in the use and understanding of computer software.
Department CMR - STRATEGIC SCIENTIFIC COMM (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Master's Degree Required
Title Medical Writer/ Sr. Medical Writer
Job Category Medical Information
Job Description PURPOSE:
The Medical Writer/ Sr. Medical Writer, working under the supervision of more senior SSC colleagues, is responsible for the preparation and tracking of documents that support the regulatory and publication activities for assigned NNI therapeutic areas.
RELATIONSHIPS:
This position reports to Associate Director in Strategic Scientific Communications (SSC). Internally, the Medical Writer/Sr. Medical Writer interacts with temporary help, administrators, internal medical writers, e-publishers, and other personnel at many levels within NNI, NN A/S, as well as other NN affiliates. Externally, the Medical Writer interacts with freelance/contract medical writers and agencies, investigators, journals, and colleagues in relevant professional associations.
ESSENTIAL FUNCTIONS:
ADVISORY BOARDS AND RESULTS MEETINGS:
With guidance assist, assist organizers in preparing slides and minutes
GENERAL:
Assists other medical writers, as per project timeline and workload demands.
Remains current with medical and regulatory guidelines as well as the literature in therapeutic areas.
Works within SSC to understand and implement document preparation procedures and Standard Operating Procedures (SOPs). Understands and follows regulatory, legal, and other relevant guidelines.
PUBLICATIONS:
With general direction, interacts with NNI and HQ publication teams, journals, editors, authors, and others as necessary to ensure the successful completion of manuscripts and other publication projects. Capable of managing multiple projects and tracking.
With guidance, prepares manuscripts, meeting abstracts, scientific poster presentations, and other items necessary for publication support. Has knowledge of, and follows, Good Publication Practices.
REGULATORY:
With general direction, assists and/or prepares clinical trial reports, summary documents, package inserts, and other documents that support the regulatory needs of a project.
With guidance assist Biostatistics group with preparation of Key Results Meeting (KRM) slides.
SCIENTIFIC MEETING ACTIVITIES:
With general direction, interacts with Medical Affairs, clinical Developments, HQ, and others as needed to assure that NNI interests are represented at designated US scientific meetings through abstracts, slide presentations, poster presentations, and other venues as appropriate. Assists HQ and other affiliates as needed with scientific presentations for meetings conducted outside the U.S.
Attend scientific meeting to gain knowledge and assist as required by authors and other colleagues
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
A M.S. or PhD in a life science or PharmD required (A minimum of two years relevant scientific/medical/ regulatory medical writing experience required with an M.S.)
Demonstrated scientific writing (e.g., manuscripts, research grants, etc…) ability.
General understanding of statistical methods, ability to learn and understand regulatory requirements and drug development processes and regulatory requirements.
Generally proficient in the use and understanding of computer software.
Department CMR - STRATEGIC SCIENTIFIC COMM (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Master's Degree Required