Senior Medical Writer

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

📋 Description

• Oversee the planning and development of high-caliber clinical regulatory documents.

• Collaborate across various departments including Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management client teams.

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

• Direct document execution and project management, which includes creating, maintaining, and communicating timelines.

• Coordinate contributions from clients, stakeholders, and internal resources such as quality control and publishing.

• Ensure that documents adhere to client processes, templates, and instructional guidelines.

• Act as a specialist in client document management systems, tools, templates, and procedures.

• Guide document messaging development in collaboration with clients.

• Analyze data and develop shell documents.

• Organize and lead kickoff meetings.

• Facilitate the resolution of review feedback and lead meetings to address comments.

• Follow up with team members to clear any remaining review feedback.

• Maintain consistency across client programs in terms of messaging, formatting, and presentation.

• Conduct literature searches when necessary.

• Execute peer quality-control reviews as required.

• Contribute to operational initiatives in medical writing 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.

• A Bachelor’s degree or higher in a relevant discipline.

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

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

• Flexibility to work across various therapeutic areas.

• Experience in crafting documents in accordance with established procedures and templates.

• Familiarity with lean authoring techniques and structured content management.

• Knowledge of ICH and US regulatory standards; familiarity with ex-US regulatory requirements is a plus.

• Proficiency in Microsoft Word and other Microsoft applications.

• Experience in developing documents using document management systems, collaborative authoring tools, and review platforms.

• Capability to adapt to new tools and technologies.

• Ability to work both independently and within a team while managing competing priorities.

• A service-oriented and proactive approach to project management.

• Excellent skills in conflict management and negotiation.

• Strong written and verbal communication skills in English.

• Must reside in Spain and be legally authorized to work in Spain (application question).

🏝️ Benefits

• Equal employment opportunity for all individuals, irrespective of protected characteristics.

• Remote work arrangement.