At a Glance
- Tasks: Lead the creation of impactful JCA Dossiers for health technology assessments.
- Company: Join a global leader in pharmaceuticals with a focus on innovation.
- Benefits: Flexible hybrid work, competitive salary, and opportunities for professional growth.
- Other info: Work in a dynamic environment with a focus on cross-functional teamwork.
- Why this job: Make a difference in healthcare by shaping critical assessment documents.
- Qualifications: 5+ years in medical writing, strong oncology knowledge, and collaboration skills.
The predicted salary is between 63000 - 77000 £ per year.
The Associate Director, Joint Clinical Assessment (JCA) Dossier Content is a role within the Global Medical & Value Capabilities (GMVC) EUCAN & EEMEA Hub, responsible for developing and writing product specific JCA Dossiers in accordance with the requirements of the EU Regulation on Health Technology Assessment (HTAR).
Key Responsibilities Include, But Not Limited To:
- Lead the writing of product specific JCA Dossiers in line with the overall product value strategy.
- Is responsible for the timely development of the required sections of the JCA Dossier template.
- Works closely with the EU HTA Dossier Lead in Market Access to assure timely execution of tasks.
- Actively provides input into strategic options related to dossier content.
- Works with the relevant functions to assure availability of content in a timely manner and a format which can be easily translated into dossier content.
- Together with the Regional Director Medical Affairs (RDMA), ensures timely communication and information to country medical teams about the JCA Dossier.
- Conducts comprehensive literature searches when needed to support content generation for the dossier.
- Stays up to date with process and implementation rules for the JCA Dossier.
- Ensures all written materials comply with the required standards and regulations according to the EU Regulation on HTAR.
- Ensures accuracy of the JCA Dossier content.
- Oversees the systematic literature review (SLR), including alignment with JCA requirements, coordination with contributing functions/vendors, and integration of outputs into the dossier.
- Actively leverages technical tools and digital solutions to streamline the creation and maintenance of the JCA Dossier.
Requirements:
- Minimum 5 years experience as an HTA writer or Medical Writer for the pharmaceutical industry, preferably in an in-house role.
- Prior experience writing large, complex documents and dossiers in English, with required adherence to template guidance.
- Demonstrated ability to integrate complex clinical, statistical, and methodological evidence into clear and scientifically robust text.
- Strong working knowledge of oncology.
- Prior experience working in a Regional or Global role or a proven track record of working effectively in close collaboration with Regional/Global teams.
- MS degree in Life Sciences or related field.
Location: The role could potentially be based in any European location where there is a local office presence, provided candidates have the required skills and experience.
Required Skills: Cross-Functional Collaboration, Global Team Collaboration, Health Technology Assessment (HTA), Medical Content Writing, Medical Writing, Oncology, Regulatory Submissions, Regulatory Writing, Scientific Writing.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Associate Director, JCA Dossier Content (EU HTA) in London employer: Merck Sharp & Dohme (MSD)
As a global healthcare leader, our company offers an inspiring work culture that prioritises ethical integrity and scientific excellence. Located in the vibrant city of London, the Associate Director role in External Discovery Chemistry provides exceptional opportunities for professional growth and collaboration with top-tier scientists across Europe. We are committed to fostering an inclusive environment where diverse ideas thrive, ensuring that every employee can contribute to meaningful advances in global healthcare.
