Principal Medical Writer – CMC Focus

Job not on LinkedIn

🔥 2 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $132k - $151k / year

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Prepare high-quality regulatory documentation for client submissions • Contribute to authorship of documents across different service lines • Lead projects and author regulatory documents for client engagements • Mentor others in regulatory document authoring • Author and lead Modules 3 and Module 2.3 • Serve as document lead for submission-level documents • Provide subject matter guidance on document preparation, review, comment resolution, and finalization • Lead project teams toward goals within timelines and budgets • Build professional client relationships and support business relationships • Identify and institutionalize effective work practices • Resolve sensitive or high-pressure project problems • Transfer knowledge across the organization

🎯 Requirements

• Bachelor’s degree or higher, scientific discipline strongly preferred • 7+ years of regulatory writing experience with Chemistry, Manufacturing, and Controls documentation • Experience in vaccines, gene/cell therapy, biologics, small molecule, manufacturing, analytical, or stability • Experience with NDAs, INDs, BLAs, or IMPDs • Experience authoring and leading Modules 3 (e.g., Modules 3.2.S and 3.2.P) and Module 2.3 • Understanding of regulatory authority guidelines and requirements • Ability to lead a project team • Understanding of regulatory requirements for different phases of development and regulatory pathways • Knowledge of global health authority requirements • Experience as a document lead in submission-level documents • Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, inserting figures, and document management techniques • Strong understanding of document creation processes and the drug development lifecycle • Ability to synthesize data across multiple sources and documents to create summary reports • Expertise in quality document preparation, document review, comment resolution/incorporation, and document finalization • Ability to own submission-level documents and lead others toward common goals within timelines and budgets • Understanding of communication best practices • Solid time management and organizational skills • Ability to develop professional client relationships and maintain current industry knowledge • Ability to identify and institutionalize effective work practices • Ability to resolve problems in sensitive or high-pressure situations • Ability to transfer knowledge and strengthen organizational capabilities

🏖️ Benefits

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