Sr Medical Writer (FSP)
About The Position
Syneos Health is seeking a Senior Medical Writer for its Clinical Solutions team. The role leads the production of clear, accurate medical-writing deliverables for individual studies, coordinating activities across departments with minimal supervision and leading resolution of client comments. Deliverables may include clinical study protocols and 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, and scientific-meeting abstracts, posters, and presentations. The writer follows applicable regulatory standards, including ICH E3, as well as company and client procedures, templates, authorship requirements, and style and formatting guides. The role coordinates quality and editorial reviews, manages source documentation, conducts peer and team document reviews, reviews statistical analysis plans and table, figure, and listing specifications, and provides feedback on statistical outputs and document needs. The writer works with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs; performs online literature searches while observing copyright requirements; and provides technical support, training, consultation, and mentorship. The position also includes resolving or escalating issues, developing expertise in relevant industry topics and regulations, monitoring project budgets and status, and completing administrative tasks. Minimal travel may be required, less than 25%. Syneos Health describes a culture focused on career development, training, peer recognition, inclusion, and total rewards. The stated salary range is $80,600 to $175,700; actual pay varies based on qualifications, skills, competencies, and proficiency. Benefits may include a company car or car allowance, medical, dental, and vision coverage, a company 401(k) match, eligibility for an employee stock purchase plan, eligibility to earn commissions or a performance-based bonus, flexible paid time off, and sick time subject to applicable requirements.
Requirements
- 3–5 years of relevant experience in science, technical, or medical writing.
- Experience in the biopharmaceutical, medical-device, or contract research organization industry.
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.
- Experience writing relevant document types.
- Extensive knowledge of English grammar and ability to communicate clearly.
- Strong familiarity with the AMA Manual of Style.
Responsibilities
- Lead the clear and accurate completion of medical-writing deliverables and manage study-related writing activities with minimal supervision.
- Coordinate medical-writing activities within and across departments and lead resolution of client comments.
- Prepare documents such as protocols and amendments, clinical study reports, patient narratives, investigator brochures, informed consents, safety and annual reports, regulatory submissions, manuscripts, and scientific-meeting materials.
- Follow applicable regulatory standards, company and client procedures, approved templates, authorship requirements, and style and formatting guides; deliver work on time and within budget.
- Coordinate quality and editorial reviews, manage source documentation, lead team document reviews, and review documents as needed.
- Peer-review documents for scientific content, clarity, consistency, and format.
- Review statistical analysis plans and table, figure, and listing specifications, and provide feedback on statistical outputs and document needs.
- Build working relationships with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs.
- Conduct online clinical literature searches and comply with copyright requirements.
- Identify and propose solutions to issues, escalating them as appropriate.
- Provide technical support, training, and consultation to department and company staff; contribute to internal materials, presentations, processes, standards, and capabilities.
- Mentor and lead less experienced medical writers on complex projects as needed.
- Develop expertise in industry topics and regulatory requirements and guidelines relevant to medical writing.
- Monitor project budget specifications, work within budgeted hours, and communicate status and changes to medical-writing leadership.
- Complete required administrative tasks within specified timeframes and perform other assigned work-related duties.
- Undertake minimal travel as required (less than 25%).
Benefits
- Medical, dental, and vision health benefits.
- Company match for 401(k).
- Eligibility to participate in an Employee Stock Purchase Plan.
- Eligibility to earn commissions or a bonus based on company and individual performance.
- Flexible paid time off and sick time, subject to applicable requirements.
- Company car or car allowance may be included.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
