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.
Principal Medical Writer – MedPubs Focus
🔥 0 minutes ago
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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/or medical communications to support all phases of product development. • Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines.
🎯 Requirements
• Bachelor’s degree required; PhD, MD or PharmD preferred; science-related field preferred. • Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. • Experience as a lead writer on a minimum of 20 manuscripts, 20 abstracts, 20 posters or oral presentations across all phases of drug development and therapeutic areas. • Advanced knowledge of ICH and related regulatory guidelines and/or ICMJE and GPP guidelines; ISMPP CMPP certification preferred. • Proficient in MS Office Suite (advanced MS Word, PowerPoint and Excel); Adobe Acrobat for developing and editing poster slides, pdf poster layouts and slide sets • Knowledge publication guidelines and industry standards, adherence to client publication policies and procedures, confidentiality, secure file transfer, copyright and privacy protection.
🏖️ Benefits
• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans
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