Senior Medical Writer - Publications

About

Roles within the Medical Writing job family are responsible for writing and editing manuscripts and other medical communications on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in‑company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication such as screening, analyzing, and summarizing additional data from other sources as needed. Conducts systematic literature searches and reviews. Prepares literature for new products and revises existing medical communication. Reviews and analyzes statistical outputs to prepare results‑based documents such as clinical study reports and development safety update reports. Supports engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Leads the resolution of comments from the client.
• Completes a variety of documents including clinical study protocols, 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 for scientific meetings.
• Adheres to established regulatory standards including ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides.
• Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Leads team document reviews and reviews documents as needed.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
• Provides feedback to define statistical output required and document needs.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate.
• Provides technical support, training, and consultation to department and other company staff.
• May contribute to development of internal materials, presentations, or changes to internal processes, standard practices, and capabilities.
• Mentors and leads less experienced medical writers on complex projects as necessary.
• Develops deep expertise on key topics in the industry and regulatory requirements and guidelines affecting medical writing.
• Works within budgeted hours and communicates status and changes to medical writing leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Experience writing relevant document types required.
• Extensive knowledge of English grammar and ability to communicate clearly.
• Strong familiarity with AMA Manual of Style.

Benefits

• Company car or car allowance
• Medical insurance
• Dental insurance
• Vision insurance
• Company match 401k
• Employee Stock Purchase Plan
• Commissions/bonus based on company and individual performance
• Flexible paid time off (PTO)
• Sick time

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.