Medical Writer II – Senior Medical Writer

This is a fully remote position, open to applicants in Maine, +3 more states.

📋 Description

• Creates, revises, and organizes content for clinical and regulatory documents.

• Oversees the precise and effective execution of medical writing outputs.

• Manages medical writing tasks associated with specific studies.

• Produces a diverse range of documents, such as clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consent forms, and more.

• Guides the resolution of feedback from clients.

• Serves as a peer reviewer for the internal team to ensure scientific accuracy, clarity, overall consistency, and adherence to format.

• Engages and cultivates positive working relationships with clients, department heads, and colleagues in data management, biostatistics, regulatory affairs, and medical affairs.

• May assist in the development of internal resources and presentations or modifications to internal processes, standard practices, and capabilities.

• Provides mentorship and leadership to less experienced medical writers on intricate projects.

⛳️ Requirements

• Bachelor’s degree in a relevant field with applicable writing experience; a graduate degree is preferred.

• 3-5 years of relevant experience in scientific, technical, or medical writing.

• Required experience in the biopharmaceutical, device, or contract research organization sectors.

• Strong familiarity with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices is essential.

• Proven experience in writing relevant document types is required.

• Comprehensive understanding of English grammar and the ability to communicate effectively; strong knowledge of the AMA Manual of Style is important.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matching 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO) and sick leave.