Senior Medical Writer – Clinical Focus

🕒 Yesterday

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $116k - $128k / year

⏰ Full Time

🟠 Senior

🏥📝 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

• Contribute to authorship of a variety of documents across different service lines • Lead smaller projects as project lead and interface directly with clients • Support larger, more complex engagements as a member of a larger delivery team • Use clinical regulatory writing expertise to lead teams and help clients achieve their goals • Understand regulatory authority guidelines and requirements • Anticipate how writing practice conventions affect final products submitted for health authority approval or acceptance • Develop submission-level documents • Develop clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE • Synthesize data across multiple data sources and documents to create summary reports • Conduct or lead a CRM and lead project teams to consensus • Present ideas and suggestions using logical arguments and respond positively to opposing views • Develop professional client relationships and maintain current industry knowledge • Identify and institutionalize effective work practices to ensure consistency in performance

🎯 Requirements

• Bachelor’s degree or higher in a scientific discipline strongly preferred • 3+ years of regulatory writing experience or equivalent experience with clinical-related documentation • Understanding of regulatory authority guidelines and requirements • Experience developing submission-level documents • Experience developing clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE • Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, and inserting figures • Knowledge of document management techniques • Strong understanding of the document creation process and drug development lifecycle • Ability to synthesize data across multiple data sources and documents • Ability to conduct or lead a CRM • Ability to lead a project team to consensus • Ability to use logical arguments to persuade others and respond positively to opposing views • Ability to develop professional relationships with clients • Ability to identify and institutionalize effective work practices

🏖️ Benefits

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans • Applicable bonus • Equal employment opportunities • Reasonable accommodations for the application, assessment, or interview process