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About the Role
We are seeking an organized, motivated, and collaborative individual to join our medical writing team. The senior medical writer will partner cross-functionally with client teams to lead the planning and preparation of high-quality clinical regulatory documents, supporting 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, to ensure timely completion of documents.
- Ensure document development adheres to relevant client processes, templates, and instructional documents.
- Serve as an expert on client document management systems and related tools, templates, and procedures.
- Lead document message development in collaboration with the 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.
- Follow up with individual team members to resolve outstanding review feedback.
- Ensure consistency among client programs in messaging, formatting, and presentation of documents.
- Conduct literature searches as needed.
- Perform peer QC review as needed.
- Contribute to medical writing operational initiatives, if needed.
Requirements
- 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical 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.
Skills
- Microsoft Word
- Microsoft applications
- Document management systems
- Collaborative authoring tools
- Review tools
- Lean authoring approaches
- Structured content management
- ICH guidelines
- US regulatory requirements
- Ex-US regulatory requirements
Location
- Fully remote in the US
- Must be able to attend key meetings on site with clients as requested
Work Type
- Fully remote
- Onsite attendance required for key meetings
Experience Level
- Senior
Education Level
- Bachelor's degree or higher
About the Company
- For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.
Equal Opportunity
- 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.