Senior Medical Writer: Clinical Regulatory & Publications

TransPerfect Translations International; Amsterdam; Hybrid; EUR 70,000 - 110,000; Full time

Job summary

TransPerfect Life Sciences is seeking a seasoned medical writer to lead preparation of regulatory documents in a collaborative, fast-paced setting in Amsterdam. The role partners with Clinical Development, Operations, Biostatistics, Regulatory, and Program Management to ensure high-quality submissions.

The ideal candidate has 5+ years in medical writing, a relevant degree, and strong English communication. Experience with ICH/regulatory standards and document management is preferred.

Qualifications

• 5+ years as a medical writer in CRO/biotech/pharmaceutical fields.
• Bachelor’s degree or higher in a relevant discipline.
• Experience writing clinical study reports and regulatory documents.
• Strong command of English, written and verbal.
• Familiarity with document templates, ICH and regulatory practices.

Responsibilities

• Lead preparation of high-quality clinical regulatory documents per guidelines.
• Coordinate cross-functional client contributors and internal resources.
• Manage timelines and project execution for document development.
• Ensure templates and processes are followed and aligned with client needs.
• Lead document messaging in collaboration with clients and teams.
• Interpret data and create shell documents to support authoring.
• Plan and lead kickoff meetings and review feedback sessions.
• Facilitate efficient resolution of review comments and follow-ups.
• Maintain consistency across programs in messaging, formatting, and presentation.
• Conduct literature searches and perform peer QC reviews as needed.
• Contribute to operational initiatives like templates and reference management.

Skills

Medical writing

Project management

Cross-functional collaboration

English communication

Education

Bachelor’s degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Collaborative authoring tools

Review tools

Job description

We’re seekingan organized, motivated, and collaborative individual for our medical writing team.

Theseniormedical writer will partner cross-functionallywith client teams inClinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management inleading theplanning and preparation of high-quality clinical regulatory documents. The medical writer may produceprotocols, publications, study reports, investigator brochures,narratives,and module documents, according to clientand agency guidelines,to support drug development underbrisktimelines.

Responsibilities:

• Lead theexecution of documents, includingproject management tasks such ascreating,maintaining, and communicatingtimelines

• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing)to ensuretimelycompletion ofdocuments

• Ensuredocument developmentadherestoanyrelevantclient processes, templates, and instructionaldocuments

• Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient documentdevelopment

• Lead document message development in collaboration withclient

• Interpret data and create shell documents to supportauthoring

• Plan and lead kickoffmeetings

• Facilitate resolution of review feedback including planningand leadingcomment resolution meetings(curate review comments to ensuremeetings areefficient)

• Follow-up with individual team members asneeded to resolve outstanding reviewfeedback

• Ensure consistency among client programs in terms of messaging, formatting, and presentation ofdocuments

• Conduct literature searches asneeded

• Perform peer QC review asneeded

• Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed

• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field

• Bachelor’s degreeor higherin a relevant field

• Oncology, InfectiousDisease, or Vaccineexperiencedesired

• Experiencedesiredin writingclinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5documents

• Flexibility towork across multiple therapeutic areas, if needed

• Experiencewriting documents according toestablished processes and documenttemplates

• Familiarity with lean authoring approachesand structured content management

• Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements isdesired

• Expertisewith Microsoft Word and other Microsoft applications

• Experiencedeveloping documentsusingdocument management systems, collaborative authoringtools, and reviewtools

• Comfortableadaptingto newtools andtechnologies, if needed

• Ability to work both independently and collaboratively in the face of competingpriorities

• Service-oriented and proactive approach to projectmanagement

• Excellent conflict management and negotiation skills

• Comfortable providing suggestions based onpreviousexperience

• Strong written and verbal communication skillsin English

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law

For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.

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