Senior Principal Medical Writer – Regulatory Submission Docs, ISE/ISS/Clinical Overview, Oncology Preferred

Syneos Health

Senior Principal Medical Writer at Syneos Health developing clinical documents for regulatory submissions globally. Collaborating with cross-functional project teams and mentoring junior writers.

Posted 6/12/2026full-timeRemote • Arizona, Maine, New Jersey, Ohio, Rhode Island • 🇺🇸 United StatesSenior💰 $95,000 - $210,900 per yearWebsite

About the role

Key responsibilities & impact

Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
Participate in cross-functional process improvement initiatives.
Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
Mentor more junior medical writing staff.

Requirements

What you’ll need

Bachelor's degree required
Advanced degree in a relevant scientific/clinical/regulatory field preferred
At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development
Proficiency in organizing and communicating clinical information required with minimal oversight
Strong organizational, time management, and project management skills are required
Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment
Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired
Proficient in MS Word
Experience with an electronic document management system and templates is required.

Benefits

Comp & perks

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time
Company car or car allowance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingregulatory documentsclinical information organizationproject managementstandard operating proceduresbiopharmaceutical experienceCRO experienceclinical developmentpreclinical developmentglobal regulatory requirements

Soft Skills

organizational skillstime managementcommunication skillsinterpersonal skillsteam collaborationmentoringprocess improvementattention to detailproblem-solvingleadership