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

Syneos Health

. Develop regulatory documents for submission to regulatory agencies globally, following ICH and other global guidelines, standards, processes, and client authoring standards .

Posted 11/3/2026full-timeRemote • PolandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing regulatory documents in compliance with ICH guidelines and global standards, while effectively managing medical writing projects and mentoring junior staff. Proficient in organizing clinical information and adhering to project timelines within the biopharmaceutical industry.

Highest-signal resume keywords

Medical Writing ExperienceRegulatory Document DevelopmentProject Management SkillsKnowledge of Global Regulatory RequirementsMS Word Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingRegulatory Document DevelopmentClinical Information OrganizationProject ManagementStandard Operating Procedures DevelopmentCross-Functional CollaborationProtocol ReviewStatistical Analysis Plan ReviewProcess Improvement InitiativesTherapeutic Area Knowledge

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationInterpersonal CommunicationOrganizational SkillsTime Management

Tools & Technologies

Electronic Document Management SystemDocument Templates

Industry Keywords

BiopharmaceuticalCROClinical DevelopmentPreclinical DevelopmentOncology

About the role

Key responsibilities & impact

Develop regulatory documents for submission to regulatory agencies globally, following ICH and other global guidelines, standards, processes, and client authoring standards
Adhere to study/project timelines and corporate objectives
Manage medical writing projects, including developing timelines and communicating with cross-functional team members about review cycles and expectations
Participate in cross-functional meetings and provide input on medical writing deliverables, timelines, and processes
Review associated project documents such as protocols and statistical analysis plans
Participate in cross-functional process improvement initiatives
Help define and write standard operating procedures and best practices for efficient preparation of quality documents
Manage internal and contract medical writing resources as required
Mentor more junior medical writing staff

Requirements

What you’ll need

Oncology experience preferred, but not required
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, or comparable experience within clinical or preclinical development
Proficiency in organizing and communicating clinical information with minimal oversight
Strong organizational, time management, and project management skills
Strong verbal, written, and interpersonal communication skills
Proficient understanding and knowledge of global regulatory requirements
Knowledge of therapeutic areas in all phases of clinical development desired
Proficient in MS Word
Experience with an electronic document management system and templates required
Equivalent experience, skills, and/or education will also be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate