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About the Role
The Associate Director, Joint Clinical Assessment (JCA) Dossier Content is responsible for developing and writing product-specific JCA Dossiers in accordance with the EU Regulation on Health Technology Assessment (HTAR). This role involves engaging with stakeholders, understanding dossier requirements, and ensuring content aligns with the overall value strategy.
Responsibilities
- Lead the writing of product specific JCA Dossiers in line with the overall product value strategy.
- 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.
- 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.
Skills
- Cross-Functional Collaboration
- Global Team Collaboration
- Health Technology Assessment (HTA)
- Medical Content Writing
- Medical Writing
- Oncology
- Regulatory Submissions
- Regulatory Writing
- Scientific Writing
Location
- European location
Work Type
- Hybrid
Experience Level
- Associate Director
Education Level
- MS degree in Life Sciences or related field
About the Company
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.