Sanofi Group Senior Medical Writer in Swiftwater, Pennsylvania

Senior Medical Writer

Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development.

The Senior Medical Writer is a member of the Clinical Team. He/she is responsible for the production of key documents related to Clinical Department and Medical Affairs activities (e.g., protocol, CSR, IB, Informed Consent Forms, clinical expert reports/

integrated summaries, CTD Modules 2 and 5, Clinical Overviews) in line with the Company as well as external standards, e.g., regulatory requirements or guidelines. For submissions), the Manager, Medical Writing can also play a key role in coordinating and overseeing the medical writers in the preparation of submission documents and the overall development of the submission.

The Senior Medical Writer

  • Is in charge of creating, writing, and coordinating protocols, informed consent forms, IBs and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs

  • Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards

  • Coordinating the medical writing CTD activities (interaction with RA and other functions involved) and providing the CTD supportive activities within the medical writing department

  • Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of medical writer).

  • Is involved in the peer-review and QC of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as the SAP from Biostatistics).

  • Contributes to the development of document templates and relevant SOPs. Leads on Process or Template improvement initiatives as requested.

  • Provides mentoring support to less experienced colleagues and new Company staff members.

  • Is in charge of supervising subcontracted medical writing activities.

The technical/functional environment is the Medical Writing platform within Clinical Operations. The Medical Writer reports to the Local Head of Medical Writing for appraisal and training. He/she may be the representative of his/her function in one or several clinical teams according to the number of projects he/she has to manage. In this case, he/she is accountable to the Clinical Team Leader for all project issues.

Education and Qualifications:

BA/BS in Biology, Life Sciences and 5 plus years of medical writing experience; Masters in Science degree, PharmD or PhD in Science is preferred.

Demonstrated experience in clinical development, strong interpersonal, time management, project management, and technical writing skills highly desirable.

Sanofi Pasteur SA 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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life