Principal Medical Writer – Clinical Focus

🔥 1 minute 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

• Prepare high-quality documentation for regulatory submissions to streamline the regulatory documentation process for clients • Contribute to authorship of various documents across different service lines • Lead projects and contribute as an author for all types of client engagements • Mentor others in authoring regulatory documents • Lead submission-level sections for clinical documents, including Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE • Lead sub-teams for pharmacovigilance and transparency and disclosure deliverables • Take responsibility for clarity of purpose and lead others toward common goals within timelines and budgets on complex projects • Manage crisis communications and risks • Identify and promptly address potential problems, particularly in sensitive or high-pressure situations • Integrate expertise across multiple therapy areas to deliver business successes and transfer knowledge across the organization

🎯 Requirements

• Bachelor’s degree (minimum) • 7+ years of regulatory writing experience with clinical-related documentation • Understanding of regulatory requirements for different phases of development and different regulatory pathways • Knowledge of global health authority requirements • Experience writing and leading a range of documents in their entirety, including study and submission level and pharmacovigilance documents • Strong understanding of the document creation process and drug development lifecycle • Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, and inserting figures • Experience with document management techniques • Ability to synthesize data across multiple data sources and documents to create summary reports • Ability to lead submission-level sections, including Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE • Ability to lead sub-teams for deliverables, including pharmacovigilance documents and transparency and disclosure deliverables • Understanding of communication best practices • Broad experience and technical expertise across more than one therapy area • Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders

🏖️ Benefits

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