Sanofi Group Manager, Medical Writing in United States
Manager, Medical Writing
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health.
Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world.
Our extensive research and development efforts address key health care challenges in cardiology, oncology, and internal medicine, as well as metabolic diseases and central nervous system disorders.
Sanofi US, along with the other US affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, employs more than 17,000 people across the country.
As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system. The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.
Commitment is our Strength. Ready to grow together.
Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call1-800-207-8049 Option 7, then Option 3.
Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Job Summary: Principal Medical Writer
The Principal Medical Writer is a key member of the Medical Writing team. The Principal Medical Writer is responsible for the development and management of medical writing deliverables that support the clinical portfolio.
Duties & Responsibilities:
In this role, the Principal Medical Writer:
Works with project teamsto prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development.
Contributes scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.
Provides leadership in completing major summary submission documents (e.g., pivotal study reports, Clinical Summary of Efficacy, Clinical Summary of Safety, and Clinical Overview) to support high-quality submission dossiers.
Ensures a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
Works effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
Mentors more junior medical writers and provides leadership in completion of large writing projects.
Bachelors degree with 8-10 years of experience as a medical writer, advanced degree preferred (e.g., Masters or Ph.D. in life sciences).
Experience preparing clinical regulatory submission documents, including CTD Module 2 summaries.
Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
Detail-oriented with excellent inter-personal and communication skills.
Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment.
Demonstrated leadership, problem-solving ability, to work simultaneously on multiple projects, and the ability to prioritize tasks leading to timely completion of high-quality documents.
Specific knowledge of company-targeted therapeutic areas is strongly desirable.
Job: Clinical Development
Primary Location: United States-US Remote-US Remote
Job Posting: Oct 25, 2016, 1:46:43 PM
Job Type: Regular
Employee Status: Regular