Sanofi
USA - Technical Writer II (Scientific) (contract)
Sanofi, Convent Station, New Jersey, us, 07961
Technical Writer II (Scientific) (contract)
Title:
Technical Writer II
Location:
100% Remote (hybrid for Morristown, NJ area candidates only)
Work Schedule:
Mon‑Fri; 9am‑5pm ET
Contract Length:
12‑month
Sanofi’s contingent workforce program, FLEXT Direct, is seeking a Technical Writer II for a 12‑month contract. The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in Sanofi’s lifecycle management (LCM) programs. They collaborate directly with Sanofi’s global business units (GBU) – Specialty Care, Vaccines, General Medicines, and Consumer Healthcare – by contributing to US, EU, and rest of world (ROW) dossiers (e.g., NDA, MAA, IND, and IMPD).
Key Responsibilities
Develop and author chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines.
Write responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports.
Author and evaluate change controls for global regulatory impact and occasionally author technical reports, position papers, white papers, or SOPs.
Ensure regulatory dossier compliance and independently author high‑quality CMC content by following regulatory guidelines, source documentation, and Sanofi’s templates.
Collaborate and coordinate with key stakeholders across GBU’s, contract manufacturing organizations (CMO), and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA).
Avoid unsolicited regulatory burden and support development of regulatory risk mitigation strategies.
Maintain up‑to‑date knowledge of Sanofi’s ways of working, SOPs, and CMC regulations and guidelines.
Support planning and preparation of timelines.
Skills And Experience
Experience with Chemistry, Manufacturing and Controls (CMC) and CTD authoring (Modules 2 and 3).
Background in pharmaceutical manufacturing or quality control/quality assurance is a plus.
Minimum 5 years of experience in the pharmaceutical industry.
Proficiency with document management systems such as Veeva or Documentum.
Working knowledge of cGMP’s is desired.
Experience with Microsoft Office suite.
Experience with small molecules and some aseptically manufactured products; medical device experience is a plus.
Excellent interpersonal communication skills; ability to interact within a multi‑disciplinary team.
Self‑motivated, highly organized, strong attention to detail, and independent prioritization.
Knowledge of U.S. pharmaceutical regulations; exposure to ex‑U.S. regulations desired.
Education BS/BA, MS, or PhD from an accredited science/health field (biology, analytical chemistry, pharmacy, or related).
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Marketing, Public Relations, and Writing/Editing
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Sanofi by 2×.
#J-18808-Ljbffr
Technical Writer II
Location:
100% Remote (hybrid for Morristown, NJ area candidates only)
Work Schedule:
Mon‑Fri; 9am‑5pm ET
Contract Length:
12‑month
Sanofi’s contingent workforce program, FLEXT Direct, is seeking a Technical Writer II for a 12‑month contract. The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in Sanofi’s lifecycle management (LCM) programs. They collaborate directly with Sanofi’s global business units (GBU) – Specialty Care, Vaccines, General Medicines, and Consumer Healthcare – by contributing to US, EU, and rest of world (ROW) dossiers (e.g., NDA, MAA, IND, and IMPD).
Key Responsibilities
Develop and author chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines.
Write responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports.
Author and evaluate change controls for global regulatory impact and occasionally author technical reports, position papers, white papers, or SOPs.
Ensure regulatory dossier compliance and independently author high‑quality CMC content by following regulatory guidelines, source documentation, and Sanofi’s templates.
Collaborate and coordinate with key stakeholders across GBU’s, contract manufacturing organizations (CMO), and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA).
Avoid unsolicited regulatory burden and support development of regulatory risk mitigation strategies.
Maintain up‑to‑date knowledge of Sanofi’s ways of working, SOPs, and CMC regulations and guidelines.
Support planning and preparation of timelines.
Skills And Experience
Experience with Chemistry, Manufacturing and Controls (CMC) and CTD authoring (Modules 2 and 3).
Background in pharmaceutical manufacturing or quality control/quality assurance is a plus.
Minimum 5 years of experience in the pharmaceutical industry.
Proficiency with document management systems such as Veeva or Documentum.
Working knowledge of cGMP’s is desired.
Experience with Microsoft Office suite.
Experience with small molecules and some aseptically manufactured products; medical device experience is a plus.
Excellent interpersonal communication skills; ability to interact within a multi‑disciplinary team.
Self‑motivated, highly organized, strong attention to detail, and independent prioritization.
Knowledge of U.S. pharmaceutical regulations; exposure to ex‑U.S. regulations desired.
Education BS/BA, MS, or PhD from an accredited science/health field (biology, analytical chemistry, pharmacy, or related).
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Marketing, Public Relations, and Writing/Editing
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Sanofi by 2×.
#J-18808-Ljbffr