Senior Medical Writer

Undisclosed; United States; Remote; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive salary and performance incentives

Health and wellbeing programs

Retirement and pension plans

Life assurance and disability coverage

Employee assistance and wellbeing resources

Structured learning and career development opportunities

Job summary

A leading global clinical research organization is seeking a Senior Medical Writer I for a 12-month FTC, fully remote. In this role, you will spearhead the development and execution of medical writing initiatives supporting innovative therapies.

The ideal candidate will have 3-5 years of experience in the pharmaceutical, biotechnology, or CRO industry and possess exceptional communication and regulatory knowledge. Competitive salary and benefits, including health programs and career development opportunities, are offered.

Qualifications

• Minimum of 3–5 years of medical writing experience within the pharmaceutical, biotechnology, or CRO industry.
• Thorough understanding of regulatory requirements, including ICH-GCP, FDA, and EMA guidelines.
• Proven ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Lead the preparation, review, and editing of clinical study protocols and reports.
• Collaborate with cross-functional teams to interpret clinical trial findings.
• Contribute to publication plans and scientific manuscripts.

Skills

Medical writing

Data interpretation

Regulatory knowledge

Communication skills

Education

Advanced degree in Life Sciences, Pharmacy, Medicine

Job description

Senior Medical Writer I 12 Months FTC I Fully Remote I Based in EU

A leading global clinical research organization is seeking a Senior or Principal Medical Writer to join its diverse and dynamic team. In this role, you will lead the development and execution of medical writing activities supporting clinical research programs and the advancement of innovative therapies.

Key Responsibilities

• Lead the preparation, review, and editing of clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submission documents.
• Collaborate with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and communicate clinical trial findings.
• Provide scientific and strategic input into clinical development programs and research initiatives.
• Contribute to publication plans, abstracts, posters, and manuscripts for scientific conferences and peer-reviewed journals.
• Mentor junior medical writers and promote best practices within the medical writing function.

Ideal Candidate

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field.
• Minimum of 3–5 years of medical writing experience within the pharmaceutical, biotechnology, or CRO industry.
• Strong ability to interpret and summarize complex clinical and scientific data.
• Thorough understanding of regulatory requirements, including ICH‑GCP, FDA, and EMA guidelines.
• Proven ability to manage multiple projects in a fast‑paced environment.
• Excellent communication, collaboration, and stakeholder management skills.

Benefits

• Competitive salary and performance incentives.
• Health and wellbeing programs.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance and wellbeing resources.
• Structured learning and career development opportunities.