Senior Medical Writer | US

OpenKrill; United States; Remote; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

TransPerfect seeks a senior medical writer to partner with Clinical Development, Regulatory, Biostatistics, and Program Management in planning and preparing high-quality regulatory documents for drug development. The role may include protocols, publications, study reports, investigator brochures, narratives, and module documents, with on-time delivery.

The ideal candidate has 5+ years of medical writing experience in CRO/biotech/pharma, a Bachelor's degree or higher, and familiarity with ICH and

Qualifikationen

• 5+ years of experience as a medical writer in CRO/biotech/pharmaceutical fields.
• Bachelor’s degree or higher in a relevant field.
• Oncology, Infectious Disease, or Vaccine experience desired.
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2 and module 5 documents.
• Familiarity with ICH and US regulatory requirements; knowledge of ex-US requirements is a plus.

Aufgaben

• Lead the execution of documents and manage timelines.
• Coordinate cross-functional client contributors and internal resources to ensure timely completion.
• Adhere to client processes, templates, and instructional documents.
• Serve as an expert on client document management systems and related tools.
• Lead document message development in collaboration with clients.
• Interpret data and create shell documents to support authoring.
• Plan and lead kickoff meetings.
• Facilitate resolution of review feedback and plan comment resolution meetings.
• Ensure consistency across client programs in messaging, formatting, and presentation.

Kenntnisse

Project management

Cross-functional collaboration

Excellent written communication

Editorial QA

Literature searching

Ausbildung

Bachelor's degree or higher

Tools

Microsoft Word

Document management systems

Review tools

Jobbeschreibung

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.