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