2 weeks ago

Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain

Syneos Health

Amsterdam

2 weeks ago

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Principal Medical Writer needed for sponsor-dedicated role at Syneos Health, focusing on regulatory documents for global submissions. Requires 5+ years of medical writing experience in biopharma/CRO industry. Remote position based in Poland, Belgium, Netherlands, or Spain.

RemoteFull-timePrincipalMedical WritingRegulatory Submissions

Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain

Apply

RemoteFull-timePrincipalMedical Writing

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

5 years

Employment Type

Full-time

Experience Level

Principal: 5+ years

Core Qualifications

Technical (Must-have)

Medical WritingRegulatory SubmissionsClinical ResearchICH GuidelinesMS WordDocument Management SystemsProject ManagementTime ManagementCommunicationMentoring

Soft Skills

OrganizationalTime ManagementProject ManagementVerbal CommunicationWritten CommunicationInterpersonal CommunicationTeamwork

Key Responsibilities

•Develop regulatory documents for submission to regulatory agencies globally.
•Manage medical writing projects, including developing timelines and communication with cross-functional teams.
•Participate in cross-functional meetings to provide input on medical writing deliverables and timelines.
•Review other documents associated with assigned projects (e.g., Protocols, Statistical Analysis Plans).
•Participate in cross-functional process improvement initiatives.
•Define and write standard operating procedures and best practices for document preparation.
•Manage internal and contract medical writing resources to ensure timely project completion.
•Mentor more junior medical writing staff.

Principal Medical WriterRegulatorySponsor-dedicatedRemoteBiotechnologyClinical ResearchMedical WritingFull-time

Core Qualifications

Technical (Must-have)

Medical WritingRegulatory SubmissionsClinical ResearchICH GuidelinesMS WordDocument Management SystemsProject ManagementTime ManagementCommunicationMentoring

Soft Skills

OrganizationalTime ManagementProject ManagementVerbal CommunicationWritten CommunicationInterpersonal CommunicationTeamwork

Key Responsibilities

•Develop regulatory documents for submission to regulatory agencies globally.

•Manage medical writing projects, including developing timelines and communication with cross-functional teams.

•Participate in cross-functional meetings to provide input on medical writing deliverables and timelines.

•Review other documents associated with assigned projects (e.g., Protocols, Statistical Analysis Plans).

•Participate in cross-functional process improvement initiatives.

•Define and write standard operating procedures and best practices for document preparation.

•Manage internal and contract medical writing resources to ensure timely project completion.

•Mentor more junior medical writing staff.