• Job Description

  Req#: R320814

  Job Description

  The EMEAC Medical Writer EU HTA Dossier is a regional role within Global Medical & Value Capabilities (GMVC), responsible for developing and writing product specific EU HTA Dossiers, in accordance with the requirements of the EU Regulation on Health Technology Assessment (HTAR); actively engages with key stakeholders to facilitate the creation and writing of product specific EU HTA dossiers; develops a clear understanding of the EU HTA dossier template and associated content requirements as well as the implementation/submission procedures.

  The EMEAC Medical Writer EU HTA Dossier represents GMVC in the product specific regional HTA dossier generation teams, and is responsible to assure incorporation of appropriate and relevant content into the EU HTA 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 EU HTA dossier content.

  All core activities have a regional scope and impact. The EMEAC Medical Writer EU HTA reports into the regional GMVC organization, and will work closely with other key functions on the local, regional and global level involved in the strategy and content for the EU HTA dossier.

  Main Responsibilities include, but are not limited to:

  • Lead the writing of product specific EU HTA dossiers in line with the overall product value strategy
  • Be responsible for the timely development of the required sections of the EU HTA dossier template
  • Work closely with the EU HTA Submission Manager to assure timely execution of tasks
  • Actively provide input into strategic options related to dossier content
  • Work 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), assure timely communication and information to countries about HTA dossier
  • Conduct comprehensive literature research where needed to support content generation for the dossier
  • Stay up-to-date with process and implementation rules for the EU HTA dossier
  • Ensure all written materials comply with required standards and regulations
  • Assure accuracy of dossier content
  • Keep oversight of vendor activities and deliverables

  Qualifications:

  Education and minimum requirements:

  • MS degree in Life Sciences or related field
  • Minimum 5 years experience as Medical Writer / HTA writer

  Required experience and skills:

  • Experience in writing HTA dossiers preferred
  • Relevant working experience as Medical Writer / HTA writer the pharmaceutical industry or at a MedComm/Medical Writing Agency is desired
  • Knowledge in related Therapeutic Area
  • Proven ability for solid networking, prioritization, and cross-functional collaboration skills
  • Organizational and Prioritization skills
  • Project management experience
  • Multi-tasking and problem-solving skills (solution-driven)
  • Experience leading the development of large manuscripts and dossiers
  • Negotiation skills for interaction with cross-functional teams
  • Solid understanding of technical writing following template guidance
  • Understanding of literature searches
  • Prior experience working in a regional or global role or proven track record of working effectively in close collaboration with regional/global
  • Strong analytical skills Must be able to work in a complex organization environment and have ability to effectively operate in a global and team-oriented structure
  • Proficiency in MS Office, including Word, Excel, PowerPoint and SharePoint
  • Good understanding of statistical terminology and analysis

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  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.

  Employee Status:

  Regular

  Relocation:

  VISA Sponsorship:

  Travel Requirements:

  Flexible Work Arrangements:

  Hybrid

  Shift:

  Valid Driving License:

  Hazardous Material(s):

  Job Posting End Date:

  11/18/2024

  *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

• About the company

  Merck & Co., Inc.

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