Freelance Medical Writer

We are an oncology-focused biotech company based in Europe. We are seeking a dedicated Medical Writer who can commit to 32 hours per week.

Key Responsibilities:

1. Write clear and concise clinical documents for submission to regulatory authorities, including:
1. Product labels (US PI, EU SmPC, CCDS)
2. Study protocols
3. Interim and final clinical study reports
4. Common Technical Document (CTD) clinical overviews and summaries
5. Safety update/aggregate reports
6. Integrated summaries of safety and efficacy
2. Drive the document preparation process by reviewing primary statistical outputs, drafting and distributing documents for review, and incorporating comments from all reviewers.
3. Conduct literature-based research to support writing activities.
4. Provide scientific and medical writing consultancy to project teams on various aspects, including renewals, benefit/risk assessments, and Independent Data Safety Monitoring Board reports, as needed.
5. Review and edit draft and final documents prepared by other writers before internal and external distribution.
6. Collaborate closely with Global Medical Leads, Medical Experts, Safety Leads, and Regulatory Leads within the organization.
7. Organize and lead document development and review meetings.
8. Oversee documents that are outsourced to contract research organizations (CROs).
9. Develop and ensure adherence to clinical and regulatory writing timelines, standards, and processes.
10. Respond to queries requiring medical expertise.

Qualifications:

1. At least 4 years of experience in a similar role.
2. An advanced degree in life sciences or a relevant scientific, clinical, or regulatory field.
3. Experience with complex diseases, preferably with expertise in oncology.
4. Ability to understand and interpret clinical and scientific data and present results clearly to a diverse audience.
5. Excellent command of the English language, with strong verbal and written communication skills.
6. Attention to detail, with flawless grammar and spelling.
7. Strong problem-solving, analytical, and organizational skills, with proven project and time management abilities.
8. A team player who can quickly build positive and productive working relationships.
9. Experience in interventional trials.
10. Ability to prioritize multiple projects effectively.

If you meet these qualifications and are interested in joining our team, we would love to hear from you!

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Writing/Editing