Freelance Medical Writer - Clinical Development (100% …, Cuesta La Bana

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 .

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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

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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

Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.