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.
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.