Freelance Senior Medical Writer

4 weeks, 1 day ago
Contract
Senior
Project and Program Management
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014

Description

  • Write and edit complex medical writing deliverables, including informed consent forms, clinical study reports, clinical evaluation reports, and CTD submissions.
  • Coordinate cross-functional stakeholders across Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Pharmacovigilance to gather and align scientific and clinical content.
  • Support the development of clinical study protocols, IBs, and INDs by ensuring timely review and integration of required materials.
  • Ensure accuracy, consistency, and regulatory compliance of all information, data, and references in deliverables.
  • Perform quality control reviews for data accuracy, formatting, language, and compliance with industry guidelines.
  • Mentor less experienced Medical Writers on complex projects.
  • Support the Principal Medical Writer in coordinating other Medical Writers or Senior Medical Writers.
  • Liaise with sponsors to negotiate changes and align on deliverables and expectations.

Requirements

  • Degree in Life Sciences.
  • At least 3 years of proven experience in medical writing.
  • Experience writing protocols, CSRs, CTDs, informed consent forms, and lay summaries.
  • Fluent in English.
  • Project management and coordination skills.
  • Previous experience in a CRO is a plus.

Benefits

  • Part-time freelancer arrangement.
  • Opportunity to work from the EU.
  • High-impact projects in Medical Affairs.
  • Supportive environment that nurtures talent and professional growth.
  • Opportunity to contribute to meaningful work that supports patient outcomes.

Interested in this position?

Apply directly on the company website

Apply Now

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