Veristat
501 - 1000 employees
💼 Consulting
🏥 Healthcare
💊 Pharmaceuticals
💰 Private equity on 2021-05
Consulting • Healthcare • Pharmaceuticals
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.
Principal Medical Writer – Clinical Focus
🔥 0 minutes ago
🌐 United States, Canada – Remote
🍂 Massachusetts – Remote
💵 $142k - $153k / year
⏰ Full Time
🔴 Lead
🏥📝 Medical Writer
🦅 H1B Visa Sponsor
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Veristat
501 - 1000 employees
💼 Consulting
🏥 Healthcare
💊 Pharmaceuticals
💰 Private equity on 2021-05
Consulting • Healthcare • Pharmaceuticals
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 plan and prepare regulatory documents and medical communications supporting all phases of product development • Organize, analyze, interpret, and present scientific and statistical information according to ICH and other regulatory guidelines • Prepare documents in accordance with company document standards • Work under the direction of Medical Writing management • Collaborate 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 • Other professional and/or educational experience may contribute toward the minimum experience requirement on a case-by-case basis • Advanced knowledge of ICH and related regulatory guidelines • Excellent written English • Keen attention to detail • Strong interpersonal and communication skills • Experience with Microsoft Office Suite is essential
🏖️ Benefits
• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans • Applicable bonus • Inclusive culture • Reasonable accommodations and accessible application experience
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