Associate Director, JCA Dossier Content (EU HTA)

Description

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).

• Actively engage with key stakeholders to facilitate the creation and writing of product specific JCA Dossiers

• Develop a clear understanding of the JCA Dossier template and associated content requirements as well as the implementation/submission procedures

• Represents GMVC in the product specific regional JCA Dossier generation teams

• Responsible to assure incorporation of appropriate and relevant content into the JCA Dossier working with cross-functional content experts

• Works closely with Market Access, HTA statistics, regional Medical Affairs, Regulatory and the Global Value & Implementation (V&I) team to align dossier content with the value strategy

• Aligns with countries on JCA Dossier content

All core activities have a Regional scope and impact. The Associate Director, JCA Dossier Content reports into the GMVC EUCAN & EEMEA Hub and will work closely with other key functions at the Local, Regional and Global level involved in strategy and content for the JCA Dossier.

Accountabilities

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:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.