Job Title: Senior Medical Writer
Job Type: Full-time, permanent
Location: UK, Sweden, Denmark & Netherlands (Remote)
Remuneration: Competitive salary and package.
Cpl Life Sciences is collaborating with a cutting-edge oncology-focused CRO that is looking for a highly collaborative Senior Medical Writer (Permanent, Full-time) with 5+ years of experience to join the team.
The Senior Medical Writer will be an integral member of our growing medical writing group and will take on a client-facing, collaborative role with direct engagement alongside medical monitors and senior leadership. In this position, you will contribute to high-quality clinical and regulatory documentation, support strategic discussions, and help shape the scientific narrative across multiple projects. The role offers meaningful visibility within the organization and requires someone who thrives in a dynamic environment, partners effectively with cross-functional experts, and represents the medical writing function with professionalism and confidence.
Key Responsibilities
The primary responsibilities of this position include, but are not limited to, the following:
Regulatory submissions — Preparation of:
* Initial Investigational New Drug (IND) applications and amendments
* Clinical study protocols and protocol amendments
* Investigator Brochures and updates
* Interim and final Clinical Study Reports (CSRs)
* IND Annual Reports
* Development Safety Update Reports (DSURs)
* Patient Informed Consent Forms (ICFs)
Qualifications:
* Bachelor’s degree required / Advanced degree preferred
* 5+ years of prior experience in a CRO/pharmaceutical environment
* 3+ years of prior relevant experience in regulatory Medical Writing (oncology required)
* Lead writer experience on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, IND applications
* Experience collaborating directly with clients/Sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings
* Proven experience with Fast Track Applications: INDs/BTDRs
* Familiarity with eCTD modules
* Familiarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology, and oncology
* Ability to work independently, meet deadlines, and be results-oriented
* Ability to manage critical issues on multiple projects simultaneously
* Function as a team player, highly organized, self-motivated, and extremely detail-oriented
* Strong oral and written communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite
For more information, please contact
This role is 100% remote, but you MUST be based and living in one of the advertised countries above.
The employer does not offer job sponsorship.