Principal Medical Writer – Nonclinical Focus

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $132k - $151k / year

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

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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 according to ICH and other regulatory guidelines and company document standards • Collaborate with cross-functional internal and external document production teams under Medical Writing management direction • Lead internal project teams and anticipate the effects of writing conventions on health authority approval or acceptance • Develop submission-level documents and own submission-level sections such as nonclinical Module 2.6 • Create summary reports by synthesizing data across multiple sources and documents • Provide subject matter guidance for document preparation, review, comment resolution and incorporation, and finalization • Lead others toward common goals within timelines and budgets on complex projects • Coach others on communication implications of decision-making • Develop professional client relationships and maintain current industry knowledge • Identify and institutionalize effective work practices to ensure consistent performance • Resolve problems in sensitive or high-pressure situations • Integrate technical expertise across multiple therapy areas and transfer knowledge across the organization

🎯 Requirements

• Bachelor’s degree required; MS or PhD preferred • 7+ years of regulatory writing experience or equivalent experience with nonclinical CTD sections • Experience with CTD sections 2.4 Nonclinical Overview and 2.6 Nonclinical Summaries • Experience with pharmacology, pharmacokinetic (ADME), or toxicology reports • Understanding of regulatory authority guidelines and requirements • Experience leading internal project teams • Experience developing submission-level documents • Intermediate Microsoft Word proficiency, including editing tools, table creation and modification, and figure insertion • Document management techniques • Strong understanding of document creation processes and the drug development lifecycle • Ability to synthesize data across multiple data sources and documents • Expertise in quality document preparation, document review, accurate comment resolution/incorporation, and document finalization • Ability to own submission-level sections and lead complex projects within timeline and budget • Understanding of communication best practices • Experience developing professional client relationships • Broad experience and technical expertise across more than one therapy area

🏖️ Benefits

• Applicable bonus • Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans