Sanofi Group Medical Writer , Manager in Bridgewater, New Jersey
Manager, Medical Writing – Diabetes/other therapeutics areas
The Manager, Medical Writing is a key member of the Medical Writing team. The Manager, Medical Writing is responsible for the development and management of medical writing deliverables that support the clinical portfolio.
• Work with project teams to 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.
• Contribute 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.
• Provide 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.
• Ensure a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
• Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
• Mentor more junior medical writers and provides leadership in completion of large writing projects.
• Bachelors’ degree (or equivalence) and 8 years of experience as a medical writer OR Master’s degree and 6 years of experience as a medical writer
• Experience preparing clinical regulatory submission documents
• Advanced degree (e.g., Masters or Ph.D. in life sciences).
• Specific knowledge of company-targeted therapeutic areas is strongly desirable.
• 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.
•Project management experience desirable
•Aptitude for/interest in new technologies applicable to Medical Writing
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.
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