Senior Medical Writer

Transperfect Gaming Solutions; Princeton (NJ); Remote; USD 110,000 - 160,000; Full time

Job summary

TransPerfect is seeking an organized medical writer to lead planning and preparation of high-quality regulatory documents for clinical development. You will collaborate with Clinical Development, Operations, Biostatistics, Regulatory, and Program Management to produce protocols, study reports, investigator brochures, and module documents within timelines.

The role is fully remote in the United States with on-site meetings as requested, requiring strong MS Word skills, regulatory knowledge, and

Qualifications

• 5+ years of medical writing experience in CRO/biotech/pharma.
• Experience writing regulatory documents (protocols, study reports, IRBs, modules).
• Familiarity with ICH and US regulatory requirements.

Responsibilities

• Lead planning and preparation of regulatory documents.
• Coordinate cross-functional client contributors and internal resources.
• Ensure adherence to client processes, templates, and SOPs.
• Serve as expert on document management systems and templates.
• Plan and lead kickoff meetings and review sessions.
• Ensure consistency across programs in messaging and formatting.
• Perform literature searches and peer QC when needed.

Skills

Medical writing

Project management

Cross-functional collaboration

Microsoft Word

Communication skills

Attention to detail

Education

Bachelor's degree or higher

Tools

Document management systems

Collaborative authoring tools

Review tools

Microsoft Office

Job description

We're seeking an organized, motivated, and collaborative individual for our medical writing team.

The senior medical writer 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. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.

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

Responsibilities

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents
• Ensure document development adheres to any relevant 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 (curate review comments to ensure meetings are efficient)
• Follow-up with individual team members as needed to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• Perform peer QC review as needed

• 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 degree or higher in a relevant field
• Oncology, Infectious Disease, or Vaccine experience desired
• Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility to work across multiple therapeutic areas, if needed
• Experience writing documents according to established processes and document templates
• Familiarity with lean authoring approaches and 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 is desired
• Expertise with Microsoft Word and other Microsoft applications
• Experience developing documents using document management systems, collaborative authoring tools, and review tools
• Comfortable adapting to new tools and technologies, if needed
• Ability to work both independently and collaboratively in the face of competing priorities
• Service-oriented and proactive approach to project management
• Excellent conflict management and negotiation skills
• Comfortable providing suggestions based on previous experience
• 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.