Freelance Senior Medical Writer

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

📋 Description

• Responsible for composing and refining intricate medical writing deliverables (such as informed consent forms, clinical study reports, clinical evaluation reports, and CTD submissions) in line with the sponsor’s and Excelya’s standard operating procedures, guidelines, and relevant legislation.

• Facilitate collaboration among cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Pharmacovigilance) to guarantee the prompt gathering, examination, alignment, and integration of scientific and clinical content necessary for creating high-quality medical writing outputs (including clinical study protocols, Investigator's Brochures, and Investigational New Drug applications).

• Ensure the precision, consistency, and regulatory adherence of all information, data, and references incorporated in the produced publications/documents while upholding elevated standards of scientific quality.

• Contribute to the quality control of documents (assessing data accuracy, formatting, language appropriateness, and compliance with industry standards).

• Mentor and guide less experienced Medical Writers on complex projects and assist the Principal Medical Writer in coordinating the efforts of other Medical Writers or Senior Medical Writers.

• Engage with sponsors to negotiate necessary changes and ensure alignment on deliverables and expectations.

⛳️ Requirements

• Bachelor’s degree in Life Sciences.

• Minimum of 3 years of demonstrated experience in medical writing.

• Proficient in writing protocols, Clinical Study Reports, CTDs, Informed Consent Forms, and lay summaries.

• Fluent in English.

• Previous experience in Contract Research Organizations (CROs) is advantageous.

• Strong project management and coordination abilities.

🏝️ Benefits

• Health insurance

• Remote work options