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Head, Global Medical Operations

Head, Global Medical Operations

Job Title: Head, Global Medical Operations
Contract Type: Permanent
Location: Virginia, USA
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: HQ7401_1503093862
Contact Name: Reece Mitellas
Contact Email: r.mitellas@sciproglobal.com
Job Published: August 18, 2017 23:04

Job Description

ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:

Publications

  • Responsible for the development of publication strategies, tactics, delivery, and budget(s) to support overall medical and business objectives. Tracks execution of plans and budgets, informing key stakeholders of challenges and opportunities.
  • Achieves full understanding of development programs, regulatory and medical strategies, and key scientific and communication objectives for the therapeutic area by interacting directly with internal stakeholders (eg, Medical Affairs, HEOR, etc), in order to develop strategically impactful scientific publications plan.
  • Chairs the Publications Management Committee to ensure rigorous review/approval and scientific excellence of publications plan and presentations
  • Attends conferences, symposia or other meetings as necessary or as assigned and acts as liaison between Communications, US and Global Medical Affairs, Global Publications, and external content contributors
  • Manages publication programs with the external vendor model and assesses performance against global publication and medical strategies. Manages assigned vendor(s) and ensures good publication practices are followed and implemented.
  • Develops and maintains relationships with external authors through scientific discourse and active participation in publication development

Clinical Research

Interacts with colleagues in Reginal Medical Affairs, R&D, and Strategy to conducts a comprehensive, yearly gap analysis which will inform the development and prioritization of the Phase IIIb/IV, Investigator Initiated Studies (IIS), and Indivior Research Awards (IRA) strategies across the lifecycle of assigned product(s)

Phase IIIb/IV studies

  • Supports the management, design and execution of clinical studies (eg, phase IIIb/IV, disease registries, epidemiological studies, outcomes surveys, etc.), collaborating closely with Regional Medical Affairs, Therapeutic Area Clinical Development head and Global Clinical Operations

IIS

  • Leads and supervises IIS program, including initial and committee reviews, approval, and execution of IIS protocols
  • Chairs IIS Committee; Manages and generates appropriate responses to applicants
  • Supervises coordination and processes for approved IIS study contracts; tracks and provides updates on approved IIS
  • Prescriber Concern Report (PCR) Process Supervises the Medical Affairs Coordinator who focuses on the Prescriber Concern Report (PCR) process
  • Evaluates and determines actions to be taken in response to PCRs forwarded by Medical Scientific & Treatment Advisors
  • Chairs the PCR Review Committee, oversees the PCR process and executes decisions
  • Manages and generates appropriate responses and communications with prescribers identified for action through the PCR process