Senior Medical Writer | Germany

TransPerfect Inc; Berlin; Hybrid; EUR 70,000 - 95,000; Full time

Job summary

TransPerfect Translations International seeks an organized, motivated medical writer to join our medical writing team in Berlin. The senior writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to lead planning and preparation of high-quality regulatory documents for drug development under tight timelines.

The role involves leading document production, coordinating contributors, ensuring templates

Qualifications

• 5+ years of medical writing experience in CRO/biotech/pharma.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2 and 5 documents.
• Flexibility to work across multiple therapeutic areas as needed.
• Experience using established templates and document templates.
• Familiarity with lean authoring approaches and structured content management.
• Knowledge of ICH and US regulatory requirements; some ex-US regulatory knowledge desired.
• Expertise with Microsoft Word and other Office tools.
• Experience developing documents using document management systems, collaborative tools, and review workflows.
• Ability to work independently and collaboratively under competing priorities.
• Strong written and verbal English communication skills.

Responsibilities

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

Skills

Medical writing

Cross-functional collaboration

Regulatory documentation

Attention to detail

Project management

Communication skills

Education

Bachelor’s degree or higher

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 .