Senior Medical Writer

transperfect; Princeton (NJ); Remote; USD 110,000 - 160,000; Full time

Job summary

TransPerfect seeks an organized, motivated senior medical writer to join our medical writing team. You will partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management to plan and prepare high-quality regulatory documents for drug development under tight timelines.

The role emphasizes lead document development, cross-functional coordination, and expert use of document management tools.

Qualifications

• Five+ years of medical writing experience in CRO/biotech/pharmaceutical fields.
• Experience writing regulatory documents (protocols, study reports, etc.).
• Familiarity with ICH and US regulatory requirements.

Responsibilities

• Lead the execution of documents and manage timelines.
• Coordinate cross-functional client contributors and internal resources.
• Ensure documents adhere to client processes and templates.
• Lead kickoff meetings and manage review feedback.
• Maintain consistency across messaging, formatting, and presentation of documents.

Skills

Medical writing

Cross-functional collaboration

Project management

Communication skills

Attention to detail

Education

Bachelor's degree

Tools

Microsoft Word

Document management systems

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.

Location: Fully remote in the US, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients asrequested.

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 skills

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.