Senior Medical Writer: Regulatory Docs & Project Lead

TransPerfect Translations International; Paris; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

TransPerfect Life Sciences in Paris is seeking an organized, motivated, and collaborative senior medical writer to lead planning and preparation of high-quality clinical regulatory documents.

You will partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to produce protocols, publications, study reports, investigator brochures, narratives, and module documents under tight timelines.

Qualifications

• 5+ years as a medical writer in CRO/biotech/pharma.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing protocols, protocols amendments, investigator brochures, module 2 and module 5 documents.
• Flexible to work across multiple therapeutic areas.
• Experience writing documents using established templates and processes.
• Familiarity with lean authoring and structured content management.
• Knowledge of ICH and US regulatory requirements; ex-US knowledge desirable.
• Expertise with Microsoft Word and related applications.
• Experience developing documents using document management systems and collaborative tools.
• Comfortable adopting new tools and technologies.
• Ability to work independently and collaboratively amid competing priorities.
• Service-oriented and proactive project management approach.
• Excellent conflict management and negotiation skills.
• Strong written and verbal English communication.

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines.
• Coordinate cross-functional client contributors and internal resources to ensure timely completion of documents.
• Ensure document development adheres to client processes, templates, and instructional documents.
• Serve as an expert on client document management systems and related tools, templates, and procedures.
• Lead document message development in collaboration with client.
• Interpret data and create shell documents to support authoring.
• Plan and lead kickoff meetings.
• Facilitate resolution of review feedback including planning and leading comment resolution meetings.
• Follow-up with team members to resolve outstanding review feedback.
• Ensure consistency among client programs in messaging, formatting, and presentation of documents.
• Conduct literature searches as needed.
• Perform peer QC review as needed.
• Contribute to medical writing operational initiatives (templates, style guides, reference management) if needed.

Skills

Medical writing

Project management

Cross-functional collaboration

English communication

Process documentation

Education

Bachelor's degree or higher

Tools

Microsoft Word

Document management systems

CollaborationTools

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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