Sanofi Group Senior Medical Writer, Bridgewater, NJ in Cambridge, Massachusetts

This is a position for an experienced Medical Writer who is able to take full responsibility for the preparation of clinical documents and regulatory dossier, including clinical protocols, study reports, Clinical Investigator Brochures, INDs/IMPDs, and CTD according to company and agency guidelines.

He/she creates clinical documentation according to company guidelines and international government regulations and presents clinical data objectively in a clear, concise format. He/she provides scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and contributes to Submission Task Force meetings and cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.

III – KNOWLEDGE AND SKILL REQUIREMENTS

Background demonstrating fully acquired competencies in writing, editing and reviewing all types of clinical documents and, possibly, registration dossiers. An experience as Medical Writer of at least 3 years, or equivalent. 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. Ability to work both autonomously and collaboratively with a team in a multicultural, multilingual, and geographically dispersed environment. Possesses a sense of urgency and deadline oriented. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. Native English speaker or with proven excellent spoken and written English. Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills.

Formal Education And/or Experience Required:

Advanced scientific degree, Master or Ph.D. in Life Sciences, PharmD, or medically qualified. Work experience of more than 3 years as a Medical Writer or equivalent, or presenting relevant specialist qualifications.

Knowledge And Skills Desirable But Not Essential:

Specific knowledge of company-targeted therapeutic areas is desirable.

IV – PRINCIPAL DUTIES AND RESPONSIBILITIES

Prepare clinical documents including Phase I, II, and III Clinical Protocols, Study Reports, and ensure their timely completion, according to company SOPs and guidelines, with the ultimate aim to gain regulatory approval of therapeutic indications. Discuss and develop concepts for, and produce or update Clinical Investigators’ Brochures (CIBs). Prepare clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Ensure a consistent style of presentation of the clinical documents to maintain quality and ease of review, and adherence to company standards. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Share experience with and train other medical writers.

V – QUALITATIVE DATA

A - Project timeline challenges may be encountered. These are solved within the context of the project team with input from the local Head of Medical Writing.

B – The Senior MW is responsible for making decisions for the documents he/she is responsible for that are aligned with company values, priorities and SOPs, and with regulatory guidelines. Major strategic and budgetary decisions must be discussed with the Head of Medical Writing.

C – Members of Study Teams (including Clinical Study Directors, Clinical Trial Managers, Biometricians, Data Coordinators, Data Programmers and Project Directors), Regulatory Operations, Drug Safety Manager and Preclinical Product Expert, CROs and Co-development partners.

Sanofi 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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