Principal Medical Writer

Key Responsibilities:

• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications.
• Organizes, analyzes, interprets, and presents scientific and statistical information according to ICH, ICMJE, and GPP guidelines.
• Works under the direction of Medical Writing management and collaborates with internal and external cross-functional teams.

Qualifications:

• Bachelor’s degree required; PhD, MD or PharmD preferred in a science-related field.
• Minimum 7 years of medical writing experience in a CRO or pharmaceutical/biotechnology setting.
• Advanced knowledge of ICH and related regulatory guidelines or ICMJE and GPP; ISMPP CMPP certification preferred.

What We Offer:

• Remote working environment with flexible time off and paid holidays.
• Medical insurance, tuition reimbursement, and retirement plans.
• A diverse, inclusive culture with 70% remote workforce and 66% women-led teams.