Senior Medical Writer

August 10

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

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Veristat

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Biotechnology • Pharmaceuticals • Science

Veristat is a specialty Contract Research Organization (CRO) that offers comprehensive clinical trial and consulting services. Particularly focused on the pharmaceutical and biotechnology sectors, Veristat supports their clients' development and regulatory strategy for complex and novel therapies. The company's expertise spans biologics, gene therapies, rare diseases, and regulatory submissions. Their services include full-service clinical trial planning, clinical trial conduct, and regulatory affairs, with a strong emphasis on adaptive designs, biostatistics, and pharmacovigilance. Veristat has been pivotal in advancing therapies through strategic consulting and clinical operations, from oncology and neurology to infectious diseases.

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Private Equity Round on 2021-04

📋 Description

• The Senior Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. • The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. • The Senior Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams. • Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. • 105+ approved therapies for marketing applications prepared by Veristat • 480+ oncology projects in the past 5 years • 350+ rare disease projects delivered in the past 5 years • Flexible, inclusive culture — 70% remote workforce, 66% women-led teams • Equal Opportunity Employer Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives.

🎯 Requirements

• Bachelor’s degree required; science-related field preferred. • Minimum of 5 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. • A minimum of 3 years of formal medical writing experience is required. • 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.