Senior Medical Writer

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee the planning and creation of high-quality clinical regulatory documentation

• Collaborate across departments with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documents

• Manage document execution and project management tasks, which includes developing, updating, and communicating timelines

• Organize client contributors, stakeholders, and internal resources, including quality control and publishing

• Ensure the development of documents adheres to client processes, templates, and instructional materials

• Act as an authority on client document management systems, tools, templates, and procedures

• Drive document message development in collaboration with clients

• Analyze data and create shell documents to facilitate authoring

• Plan and conduct kickoff meetings

• Manage review feedback and lead comment resolution discussions

• Follow up with team members to address pending review feedback

• Ensure uniformity in messaging, formatting, and presentation across client programs

• Conduct literature searches when necessary

• Perform peer quality control reviews as needed

• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

⛳️ Requirements

• A minimum of 5 years of experience as a medical writer in the CRO/biotech/pharmaceutical sector

• Bachelor’s degree or higher in a relevant discipline

• Experience in Oncology, Infectious Disease, or Vaccine development is preferred

• Proven experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents is desired

• Willingness to work across various therapeutic areas, if required

• Proficient in producing documents in accordance with established processes and templates

• Understanding of lean authoring methodologies and structured content management

• Knowledge of key clinical and regulatory document requirements, including ICH and US regulations

• Familiarity with ex-US regulatory requirements is a plus

• Proficient in Microsoft Word and other Microsoft applications

• Experience creating documents utilizing document management systems, collaborative authoring tools, and review platforms

• Comfortable adapting to new tools and technologies

• Ability to work both independently and collaboratively while managing competing priorities

• A service-oriented and proactive attitude towards project management

• Excellent skills in conflict management and negotiation

• Strong verbal and written communication skills in English

• Must reside in Poland and have legal authorization to work there

🏝️ Benefits

• Equal employment opportunity irrespective of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law