Veristat
501 - 1000 employees
đź’Š Pharmaceuticals
🧬 Biotechnology
🤝 B2B
đź’° 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.
Senior Medical Writer
đź•’ February 16
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Veristat
501 - 1000 employees
đź’Š Pharmaceuticals
🧬 Biotechnology
🤝 B2B
đź’° 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.
đź“‹ 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 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.
🏖️ Benefits
• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans
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