Principal Medical Writer

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

📋 Description

• Oversee the precise and effective completion of intricate medical writing deliverables.

• Manage medical writing tasks for specific studies, establish document strategies, and synchronize activities among various departments.

• Produce clinical and regulatory documents, including manuscripts, abstracts, posters, and presentations.

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

• Facilitate team document reviews and orchestrate quality and editorial assessments.

• Act as a knowledgeable peer reviewer for internal teams.

• Evaluate statistical analysis plans alongside table, figure, and listing specifications.

• Cultivate relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs.

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

• Identify solutions, serve as a technical subject matter expert, and aid in the enhancement of internal materials and processes.

• Mentor and guide less experienced medical writers.

• Develop expertise in industry-specific topics and regulatory requirements, while engaging with industry groups.

• Monitor project budgets, assist in bid projections, and communicate updates on status and timelines.

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

• Carry out administrative tasks and fulfill other assigned responsibilities.

⛳️ Requirements

• An advanced degree in a scientific field is required (MS, PhD, PharmD, MD, or equivalent).

• A PhD or PharmD is strongly preferred.

• At least 5 years of relevant experience in the pharmaceutical, biotechnology, medical communications, or consulting sectors.

• Proven experience in leading publication planning, publication strategy, and execution programs.

• A solid record of developing and implementing integrated publication plans across various studies and assets.

• Strong practical experience in scientific writing and content development, including manuscripts, congress abstracts, posters, and presentations.

• Experience with AI tools and technologies to assist in publication development is preferred.

• Preferred location: U.S. East Coast.

• Ability to comply with ICH E3 guidelines, company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guidelines.

• Minimal travel may be required (less than 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive total rewards program.

• Company car or car allowance offered.

• Medical, dental, and vision health benefits available.

• 401k with company matching.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO) policy.

• Sick leave provided.

• Reasonable accommodations available when appropriate.