Hays is collaborating with an international pharmaceutical company specialized in the development, manufacturing, and commercialization of medicines, with a strong focus on generics and a solid commitment to R&D and clinical development.
The project focuses on the review and validation of clinical and bioanalytical documentation within the Clinical Development area, in close collaboration with CROs and internal teams such as Quality and Pharmacovigilance. The team is currently in an active phase reviewing multiple clinical studies, with potential continuity depending on upcoming regulatory needs.
We are currently looking for a Medical Writer – Clinical Development (Freelance) to support this project, working closely with the clinical team and external partners.
Key Responsibilities
- Review clinical and bioanalytical documentation, including Clinical Study Reports (CSRs), PK/BE reports, and related materials
- Assess bioanalytical reports in compliance with ICH M10 guidelines
- Ensure consistency across clinical, statistical, and bioanalytical data
- Perform quality control (QC) of documentation: PK data, adverse event reporting, and overall consistency
- Liaise with CROs for document review and validation
- Support, when required, the review of study protocols and informed consent forms (ICFs)
- Collaborate with internal stakeholders: Clinical Development, QA, and Pharmacovigilance
- Ensure compliance with regulatory standards (ICH E3, E6, E9, M10;
GCP)
Requirements
- Considerable experience as a Medical Writer in a clinical research environment
- Proven experience in clinical documentation (CSRs, protocols) and bioanalytical documentation
- Strong knowledge of ICH guidelines (E3, E6, E9, M10) and GCP (GLP is a plus)
- Experience working with CROs
- Ability to work independently while collaborating with cross-functional teams
- Advanced level of English
Nice to Have
- Experience in pharmacokinetics and bioequivalence (PK/BE)
- Knowledge of statistics applied to clinical trials
- Previous experience reviewing bioanalytical reports
What We Offer
- Contract opportunity through Hays, working with an international pharmaceutical company
- Part-time project (approximately 3 full days per week)
- Possibility of 100% remote work
- Close collaboration with the Clinical Development team
- Initial duration of 4 months (likely to extend) with immediate start