Principal Medical Writer – Publications

This is a fully remote position, open to applicants in Vermont.

📋 Description

• Oversee the precise and thorough execution of intricate medical writing deliverables.

• Manage medical writing tasks for specific studies, establish document strategies, and coordinate efforts across various departments.

• Produce clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations.

• Implement regulatory standards, company SOPs, client guidelines, approved templates, authorship stipulations, as well as style and formatting manuals.

• Provide guidance to clients and study teams regarding data presentation and production methodologies.

• Lead document reviews and organize quality and editorial assessments.

• Act as an expert peer reviewer and a technical subject-matter authority.

• Evaluate statistical analysis plans and specifications for tables, figures, and listings.

• Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online clinical literature searches while adhering to copyright regulations.

• Detect and resolve issues, and contribute to internal materials, procedures, standards, and capabilities.

• Mentor and guide less experienced medical writers.

• Cultivate knowledge in industry topics and regulatory requirements; engage with industry associations.

• Monitor project budgets, assist with bid forecasts, and communicate project status and modifications.

• Represent medical writing in study teams, at conferences, meetings, and client presentations.

• Execute administrative tasks and other assigned responsibilities.

• Occasional travel may be necessary, not exceeding 25%.

⛳️ Requirements

• Extensive experience and in-depth knowledge in medical writing and clinical research documentation.

• Capability to manage complex medical writing deliverables with limited supervision.

• Familiarity with ICH E3 guidelines and regulatory standards.

• Understanding of company standard operating procedures, client requirements, approved templates, authorship standards, and style and formatting guides.

• Ability to counsel clients and study teams on data presentation and production strategies.

• Proficiency in reviewing statistical analysis plans and table/figure/listing specifications.

• Competence in conducting online clinical literature searches and ensuring compliance with copyright laws.

• Expertise in industry-related topics and regulatory requirements influencing medical writing.

• Ability to mentor and oversee less experienced medical writers.

• Skills to negotiate timelines and assigned deliverables.

• Limited travel availability, less than 25%.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Peer recognition and comprehensive rewards program.

• An inclusive workplace culture.

• Company vehicle or vehicle allowance.

• Medical, dental, and vision health benefits.

• Company-matching 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on company and individual performance.

• Flexible paid time off (PTO).

• Sick leave benefits.