Senior Medical Writer
Updated: October 14, 2025
Location: IND – Remote
Job ID: 25101484
Company: Syneos Health®
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We combine clinical, medical affairs, and commercial expertise to create real-world impact and bring therapies to patients faster.
Our Clinical Development model puts both the customer and the patient at the center of everything we do. We strive to make Syneos Health both easier to work with and work for — by simplifying processes, fostering innovation, and encouraging collaboration across teams.
With 29,000 employees across 110 countries, we’re passionate about transforming lives through science.
🟩 Motto: WORK HERE MATTERS EVERYWHERE.
Career growth and continuous learning opportunities.
Supportive and engaged line management.
Technical and therapeutic area training programs.
Peer recognition and total rewards program.
Commitment to Total Self culture — encouraging authenticity and inclusivity.
Diverse global workforce where everyone feels they belong.
As a Senior Medical Writer, you will lead, manage, and develop a wide range of clinical and regulatory documents. The role requires strong scientific writing, communication, and leadership skills, with the ability to manage multiple deliverables independently across functional departments.
You will also mentor junior writers and ensure adherence to international guidelines, regulatory standards, and company SOPs.
Lead assigned writing projects and mentor junior writers on complex assignments.
Manage and coordinate medical writing activities across departments with minimal supervision.
Oversee full document life cycle — from planning, drafting, and review to final delivery.
Handle Standard Operating Procedures (SOPs), process maps, and training documentation.
Resolve issues or escalate as appropriate during the document preparation process.
Communicate effectively with cross-functional teams and clients.
Compile, write, and edit a wide range of deliverables including:
Clinical and regulatory documents (protocols, reports, investigator brochures, narratives).
Operational materials (SOPs, process maps, training guides).
Scientific communications (manuscripts, abstracts, presentations).
Create process maps from technical materials or client input using tools such as MS Visio.
Review statistical analysis plans (SAPs), tables, figures, and listings for accuracy and consistency.
Conduct online clinical literature searches as needed.
Adhere strictly to regulatory standards (ICH, FDA, EMA) and company/client templates.
Serve as peer reviewer on internal review teams.
Ensure all deliverables are scientifically sound, consistent, and aligned with client expectations.
Maintain awareness of current regulatory guidelines and industry trends.
Monitor project budget and timelines, communicating any changes proactively.
Complete administrative and compliance-related tasks within deadlines.
Perform other related duties as assigned.
🔸 Travel Requirement: Minimal (<25%)
Bachelor of Science (B.Sc.) with relevant writing experience, OR
Bachelor of Arts (B.A.) in Social Sciences, English, or Communications with demonstrated scientific/medical understanding.
Minimum 5 years of experience in medical writing.
Proven track record in end-to-end project management.
Prior experience creating SOPs, process documents, and training content.
Proficiency in MS Office Suite (Word, Excel, PowerPoint, Email, Internet).
Experience with MS Visio or equivalent process-mapping tools.
Excellent written and verbal communication skills.
Strong understanding of FDA, ICH, and AMA guidelines.
Familiarity with clinical research principles and interpretation of clinical data.
Excellent proofreading, presentation, and leadership abilities.
P22-level writers are responsible for creating and managing high-quality scientific and regulatory documents, ensuring clarity, compliance, and accuracy.
Manuscripts, monographs, and comprehensive reviews.
Clinical study protocols, amendments, and reports.
Patient narratives, annual and periodic safety reports.
Investigator brochures and informed consent documents.
IND/NDA/eCTD submissions.
Plain language summaries, abstracts, and presentations.
Lead document development independently with minimal supervision.
Coordinate with cross-functional teams to deliver on-time, quality outputs.
Mentor junior writers and provide quality oversight.
Conduct systematic literature reviews and data summarization.
Review statistical outputs and integrate into scientific documents.
Ensure adherence to ICH E3, company SOPs, and client-specific templates.
Participate in regulatory interactions via briefing books and response documents.
Leading and finalizing complex writing deliverables.
Managing and coordinating writing activities across departments.
Ensuring quality and editorial consistency across all outputs.
Reviewing statistical plans, tables, and figures for correctness and format.
Mentoring and training junior writers.
Providing technical guidance and subject-matter expertise.
Developing deep knowledge of evolving industry regulations and standards.
Maintaining adherence to budget and timelines.
Partnered in 94% of all Novel FDA-approved drugs.
Contributed to 95% of EMA-authorized products.
Supported 200+ studies across 73,000 sites and 675,000+ trial participants.
🌐 Website: www.syneoshealth.com
Duties and tasks may change based on business needs.
Equivalent experience, skills, or education may be considered.
The company complies with ADA and EU Equality Directive requirements.
This description does not constitute an employment contract.
👉 Apply Now: Syneos Health Careers
💡 Not ready to apply? Join our Talent Network to stay informed about future opportunities.
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