Principal Medical Writer – Regulatory Submission

Syneos Health

. Develop regulatory documents for global submission to regulatory agencies in accordance with ICH, global guidelines, standards, processes, and applicable Incyte authoring standards .

Posted 10/22/2026full-timeRemote • IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing regulatory documents for global submissions, adhering to ICH guidelines, and managing medical writing projects. Proven ability to mentor junior staff and improve processes for efficient document preparation.

Highest-signal resume keywords

Regulatory Document DevelopmentICH Guidelines KnowledgeMedical Writing Project ManagementCross-Functional CommunicationStandard Operating Procedure Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document DevelopmentMedical WritingProject ManagementProtocol ReviewStatistical Analysis Plan ReviewProcess ImprovementStandard Operating Procedure Writing

Soft Skills

MentoringCommunicationCollaboration

Industry Keywords

Global SubmissionCross-Functional TeamsIncyte Authoring StandardsQuality Documents

About the role

Key responsibilities & impact

Develop regulatory documents for global submission to regulatory agencies in accordance with ICH, global guidelines, standards, processes, and applicable Incyte authoring standards
Manage medical writing projects, including timelines and communication with cross-functional teams regarding review cycles and expectations
Participate in cross-functional meetings and provide input on medical writing deliverables, timelines, and processes
Review associated project documents, including Protocols and Statistical Analysis Plans
Participate in cross-functional process improvement initiatives
Define and write standard operating procedures and best practices for efficient preparation of quality documents
Manage internal and contract medical writing resources to ensure timely project completion
Mentor junior medical writing staff
Express interest for consideration in a potential upcoming opportunity and talent pipeline

Requirements

What you’ll need

Experience developing regulatory documents for submission to regulatory agencies globally
Knowledge of ICH and other global guidelines, standards, and processes
Ability to adhere to study/project timelines and corporate objectives
Ability to manage medical writing projects and develop timelines
Experience communicating with cross-functional team members and participating in cross-functional meetings
Ability to review project documents such as Protocols and Statistical Analysis Plans
Experience with process improvement initiatives
Ability to define and write standard operating procedures and best practices
Ability to manage internal and contract medical writing resources
Ability to mentor junior medical writing staff
Equivalent experience, skills, and/or education may be considered

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Total Self culture supporting authenticity and belonging
Diversity, equity, and inclusion-focused workplace culture
Remote work (Remote (Pre-Approved))