Medical Writer , Manager
Bridgewater, New Jersey
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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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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