Senior Medical Writer | UK

TransPerfect Inc; Greater London; Hybrid; GBP 65,000 - 95,000; Full time

Job summary

TransPerfect Translations International seeks a highly organized, motivated, and collaborative senior medical writer to join our medical writing team in Greater London.

You will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents for drug development under tight timelines.

Qualifications

• Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing documents according to established processes and templates.
• Familiarity with lean authoring approaches and structured content management.

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 (e.g., QC, publishing) 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 system and related tools, templates, and procedures to ensure efficient document development.
• 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.

Skills

Medical writing

Project management

Cross-functional collaboration

Regulatory document knowledge

Communication skills

Education

Bachelor’s degree or higher (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.