Senior Medical Writer, Publications

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

📋 Description

• Oversee the precise and thorough completion of medical writing deliverables.

• Manage medical writing tasks for specific studies and coordinate efforts across departments.

• Address and resolve client feedback effectively.

• 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 scientific meeting presentations.

• Ensure compliance with regulatory standards, SOPs, client specifications, approved templates, authorship criteria, as well as style and formatting guidelines.

• Organize quality and editorial reviews while managing source documentation.

• Facilitate team document evaluations and serve as an internal peer reviewer.

• Assess statistical analysis plans and table/figure/listing specifications.

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

• Conduct online searches for clinical literature.

• Identify issues and suggest solutions, escalating matters as necessary.

• Offer technical support, training, and consultation.

• Contribute to internal materials, presentations, processes, standard practices, and organizational capabilities.

• Mentor and guide less experienced medical writers through complex projects.

• Build expertise in industry trends and regulatory requirements.

• Monitor project budgets and communicate updates and changes to medical writing leadership.

• Execute administrative tasks and other assigned responsibilities.

• Travel minimally, if necessary.

⛳️ Requirements

• Extensive experience and expertise in medical writing and clinical research documentation.

• Capability to lead medical writing deliverables with little oversight.

• Familiarity with ICH E3 guidelines, regulatory standards, SOPs, client specifications, templates, authorship criteria, and style and formatting guidelines.

• Proficient in coordinating quality and editorial reviews.

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

• Competent in performing online clinical literature searches while adhering to copyright regulations.

• Ability to identify and resolve issues, providing technical support, training, and consultation.

• Experience mentoring and guiding less experienced medical writers.

• In-depth knowledge of relevant industry topics and regulatory guidelines.

• Capacity to work within budgeted hours and effectively communicate status and updates.

• Limited travel may be required (under 25%).

• Equivalent experience, skills, and/or education may also be considered.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and total rewards program.

• An inclusive workplace culture.

• Company-provided car or car allowance.

• Medical, dental, and vision health benefits.

• 401(k) company match.

• 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).

• Sick leave.

• Reasonable accommodations provided when appropriate.