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Sanofi US

Sanofi US is hiring: Medical Writer in Morristown

Sanofi US, Morristown, NJ, United States, 07961

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Medical Writer

Location: US, Morristown, NJ / M Station

Job type: Full time

About you

Sanofi is seeking a highly organized, detail-oriented Medical Writer to join our team. In this role, you will develop regulatory-compliant clinical documents supporting our product lifecycle while embracing innovative digital solutions. The ideal candidate will possess excellent communication skills, regulatory acumen, and the ability to work independently on multiple projects within tight deadlines. You should have an in-depth understanding of medical terminology and the ability to interpret complex data for various stakeholders. We are looking for a creative and passionate candidate eager to contribute to our mission of developing innovative solutions to improve people's health and well-being.

Responsibilities

  • Create high-quality regulatory-compliant clinical documents supporting product life cycle.
  • Ensure timely delivery while maintaining compliance with company SOPs and guidelines.
  • Support implementation of new digital technologies and AI solutions.
  • Participate in process improvements for efficiency gains.
  • Prepare clinical for registration dossiers and Health Authority responses under guidance.
  • Maintain awareness of regulatory documentation requirements.
  • Work effectively with cross-functional teams and update relevant stakeholders on project progress and needs.
  • Maintain accurate information in planning, tracking, and reporting tools.
  • Oversee writing activities from vendors and review vendor deliverables.
  • Ensure consistent document style and adherence to company standards.
  • Build effective relationships with stakeholders and partners.

Core Experience

  • Minimum 1 year as medical writer or equivalent experience in Clinical Research, preferably in pharma.
  • Ability to clearly, accurately, and concisely write/prepare clinical documents in English.
  • Experience in preparing clinical documents and regulatory submissions.

Clinical Development Knowledge

  • Basic understanding of clinical development processes.
  • Knowledge of clinical study methodology and basic statistics.
  • Familiarity with regulatory environment and medical terminology.
  • Proficient in document management systems and authoring platforms.

Professional Attributes

  • Strong attention to detail and deadline management.
  • Strong organizational and follow-up abilities.
  • Ability to work independently and in global teams.

Technical Skills

  • Proficiency in electronic document management and Microsoft Office.
  • Interest in implementing emerging innovative digital technologies, including AI-assisted document authoring solutions.

Education

Advanced scientific degree in life sciences, PharmD, or medical qualification (MD, clinician, nurse practitioner).

Equal Opportunity Statement

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. 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.

Salary range: $100,500.00 - $145,166.66. Additional benefits information can be found through the link.

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