Senior Medical Writer

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

📋 Description

• Lead the formulation and implementation of medical writing strategies for clinical research initiatives.

• Independently generate clinical and regulatory documents in partnership with Principal/Senior Principal Medical Writers.

• Create documents such as Clinical Study Protocols and Clinical Study Reports spanning Phase 1 to Phase 3 and various therapeutic areas.

• Analyze and critically evaluate data to identify the optimal method for drafting each document.

• Utilize lean writing methodologies.

• Serve as the main point of contact for study teams concerning document preparation, planning, and timelines.

• Facilitate document reviews to ensure that all materials are submission-ready and receive final approval.

• Work directly with Quality Control personnel and publishing specialists throughout the document preparation process.

• Mentor and guide junior medical writers on best practices, writing techniques, and scientific principles.

• Promote excellence, collaboration, and ongoing learning within the medical writing team.

⛳️ Requirements

• 3-5 years of experience as a regulatory writer.

• Required experience in protocol writing for Phase II or III studies.

• Experience with Clinical Study Reports is preferred.

• Bachelor's degree in a relevant scientific discipline or a healthcare-related field.

• Competence in interpreting and summarizing intricate clinical trial data, scientific research results, and statistical analyses.

• Exceptional writing, editing, and proofreading abilities.

• Strong knowledge of regulatory requirements, including ICH-GCP, FDA, and EMA, that govern the preparation and submission of clinical documents and publications.

• Experience engaging with regulatory agencies during the review and approval phases.

• Outstanding interpersonal and communication skills.

• Ability to effectively collaborate with cross-functional teams, cultivate relationships with key stakeholders, and influence decision-making processes.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, which may include medical, dental, and vision coverage.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.