Principal​/Sr Medical Writer; Regulatory & Publications

Principal/Sr Medical Writer (Regulatory & Publications)

Updated: Yesterday

Location: USA-MS-Remote

Job :

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model places the customer and the patient at the center of everything we do, simplifying and streamlining our work to be both easier to work with and easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovate as a team, and help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

• We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself.
• We continuously build the company we want to work for and our customers want to work with, fostering a place where everyone feels they belong.

• Lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities associated with individual studies, define document strategy, and coordinate activities within and across departments with minimal supervision. Lead the resolution of client comments.
• Complete a variety of documents, including 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 abstracts, posters, and presentations for scientific meetings.
• Adhere to established regulatory standards (e.g., ICH E3 guidelines) and company SOPs, client standards, approved templates, authorship requirements, and style guides on time and within budget.
• Advise clients and study teams on data presentation and production strategies to meet client objectives while maintaining quality standards.
• Lead team document reviews, review documents for technical issues, coordinate quality and editorial reviews, and ensure source documentation is managed appropriately.
• Serve as an expert peer reviewer, providing comments that maximize clarity, accuracy, and relevance, ensuring client objectives are met.
• Review statistical analysis plans and table/figure/specification documents for content, grammar, format, and consistency; provide feedback to define required statistical outputs and document needs.
• Interact and build working relationships with clients and cross‑functional teams in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables and advance company priorities.
• Perform online clinical literature searches while complying with copyright requirements.
• Identify and propose solutions to resolve issues, escalating as appropriate; serve as a key technical SME and contribute to internal materials and presentations.
• Mentor and lead less experienced medical writers on complex documents.
• Develop deep expertise on key industry topics and regulatory requirements that affect medical writing; engage externally with industry groups on initiatives.
• Maintain awareness of budget specifications for assigned projects, communicate status and changes to leadership, and contribute to bid projections.
• Represent the medical writing department on clinical study teams, at conferences, meetings, and for client presentations regarding writing projects.
• Complete required administrative tasks within specified time frames.
• Perform other related duties as assigned.
• Travel may be required (less than 25%).

We are excited to connect with great talent. This posting is intended for a…