Principal Medical Writer – Clinical Focus

🔥 16 hours ago

🌐 Germany, Portugal – Remote

🇩🇪 Germany – Remote 🇵🇹 Portugal – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

👻 Ghost score 10%

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Veristat

WebsiteLinkedInAll Job Openings

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 • Ensure work complies with ICH, other regulatory guidelines, and company document standards • Lead submission-level sections of complex clinical documents within timeline and budget • Take responsibility for clarity of purpose and lead others toward common project goals • Integrate expertise across multiple therapy areas to deliver business successes • Transfer medical writing knowledge to strengthen organizational capabilities • 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 this minimum requirement, as determined on a case-by-case basis • Ability to lead submission-level sections, including Clinical Study Reports, Protocols, Investigator Brochures, Integrated Summary of Safety, and Integrated Summary of Effectiveness • Broad experience and technical expertise across more than one therapy area • 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, including advanced Microsoft Word proficiency • Driving/travel requirements: 0–10% (national and international) • Ability to occasionally lift/move up to 25 lbs • Minimum weekly work hours set in accordance with local regulations

🏖️ Benefits

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