Sanofi Group Sr. Medical Writer in Cambridge, Massachusetts

Senior Medical Writer

The Senior Medical Writer is a key member of the Medical Writing team. The Senior Medical Writer is responsible for the medical writing deliverables that support the clinical portfolio.

Major Duties/Responsibilities :

  • Works 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.

  • 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.#

  • 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.

Required Education/Experience

  • Bachelors degree with 5 years of experience as a medical writer.

  • 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.

Preferred Education/Experience

  • Advanced degree (e.g., Masters or Ph.D. in life sciences).

  • Specific knowledge of company-targeted therapeutic areas is strongly desirable.

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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Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.