Principal Medical Writer

🕒 5 days ago

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Logo of Veristat

Veristat

501 - 1000 employees

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

💰 Private equity on 2021-05

Pharmaceuticals • Biotechnology • B2B

Veristat is a clinical development services company that provides end-to-end, regulatory-focused support for biopharmaceutical and medical device sponsors. The firm offers full-service clinical trial planning and conduct, regulatory affairs and submission support (including NDA/MAA and interactions with agencies like PMDA), statistical and biometrics services, medical writing, pharmacovigilance, and project management for complex therapeutic areas such as oncology, rare diseases, neurology, biologics, and cell & gene therapies. Veristat operates as a B2B partner to biotech and pharmaceutical organizations to reduce development risk and accelerate regulatory approval.

📋 Description

• Independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. • Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with ICH and other regulatory guidelines. • Works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.

🎯 Requirements

• Bachelor’s degree required; science-related field preferred. • Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. • Advanced knowledge of ICH and related regulatory guidelines. • Excellent written English and keen attention to detail. • Strong interpersonal and communication skills. • Experience with Microsoft Office Suite is essential, including advanced Microsoft Word proficiency.

🏖️ Benefits

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans

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