Senior Medical Writer

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 .