Associate Director, Final Medical Signatory

3 months ago

London, United Kingdom Organon Full time

Job Description

Position Overview The primary responsibilities of the Medical Services Lead is to triage and respond to all inquiries received through different channels from healthcare providers and other external stakeholders, and manage the processes related to promotional review ensuring the highest standards in medical communications.

Primary Responsibilities

Medical Review

  • Manage all the processes related to promotional material review and approval (i.e. review flows, priorities, outsourcing, metrics, SOP, implementation of regional initiatives).
  • Be knowledgeable of the different regulations and laws governing promotional materials in the country.
  • Ensure that medical review of materials is completed with accuracy and in a timely manner, meeting company policies and country regulations prior to public release.
  • Provide compliance leadership and training to country staff.

Medical Information

  • Respond to or triage unsolicited on-label and off-label inquiries received from healthcare providers and other external and internal stakeholders.
  • Ensure that responses to medical inquiries are high-quality professional communications.
  • Set-up standardized answers for frequently asked questions or routine requests, in collaboration with Medical Advisors and Medical Science Liaisons.
  • Research, assess, and compile responses from published and unpublished literature to create clinical support in a fair, balanced, and scientifically accurate format.
  • Report adverse events and product quality complaints to the appropriate departments.

DPOC (Designated Point of Contact) Process Management

  • Ensure receipt, classification, and appropriate routing of product inquiries for further processing to meet regulatory and business requirements.
  • Assure DPOC database is accurately maintained.
  • Generate and report DPOC monthly key performance metrics.
  • Identify gaps within the medical information process and provide rapid resolution.
  • Support and train Medical Advisors/Medical Science Liaison and other staff in the management of DPOC/medical information requests.

Education / Certificates

  • GPhC registered pharmacist or GMC registered doctor
  • UK Final Medical Signatory

Competencies and experience​

  • At least 5 years' experience in the pharmaceutical industry
  • In-depth understanding of the ABPI code.
  • Ability to understand and apply SOP´s and regulations related with promotional review, MIR, DPOC
  • Ability to identify and escalate risks/issues that arise within ORD functional areas
  • Ability to manage the different systems related with the position
  • KPI´s analysis on regular basis
  • Ability to work with partners (Commercial and medical affairs) in order to ensure the proper alignment and accelerate the approval process

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

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