Job Details

ID #41031514
State Massachusetts
City Boston
Job type Contract
Salary USD competitive competitive
Source Real Staffing
Showed 2022-05-17
Date 2022-05-17
Deadline 2022-07-16
Category Systems/networking
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Director, Systems and Operations Excellence

Massachusetts, Boston, 02108 Boston USA

Vacancy expired!

Objectives

  • Ensures that all TAs follow a standard methodology and quality for evidence generating activities.
  • Ensures compliance by cooperating with relevant internal partners to oversee the administration and correct usage of GMA-related research IT systems/digital applications, such as iEenvision, CTMS, Nexus, and FMV tools.
  • Collaborates with Company Solutions & Analytics to give metrics and KPIs to the business.
  • Responsible for collaborating with the regions on training and spreading operational excellence in evidence creation, including best practice sharing.
  • Assists in the creation of evidence-gathering policies and SOP trainings.
  • Ensure high-quality outputs by leading and managing a team that works across GMA Therapeutic Areas (TA) and functions.

Accountabilities
  • Oversees the creation, implementation, administration, and correct use of procedures, systems, and tools to ensure that Medical Affairs evidence generation is delivered in a timely and compliant manner.
  • Facilitates alignment with other business departments within the company, notably GPTs, Regions/BUs, and R&D, to guarantee consistency in asset level research and data standards understanding and implementation.
  • Oversees data curation and creation processes, systems, and activities from a range of internal and external sources to ensure data is centrally kept, controlled, and accessible in real-time to multiple stakeholders.
  • Assists in the creation and implementation of suitable tools, creative techniques, and collaborations with various business units within the organization to support evidence generation planning and excellence.
  • Assists with plans and efforts to ensure that best practices are maintained throughout TAs and Medical Affairs Units at the global, regional, and local levels.
  • Serves on several cross-functional leadership teams as a research functional specialist.
  • Ensures that audits and inspections linked to medical evidence generating IT systems/digital applications and procedures are supported.

Decision-making and Autonomy
  • Broad decision making responsibilities:
- Ability to make exceedingly complicated, enterprise-wide judgments - Responsible for the Regional Evidence Generation Operations function's decision-making. - Ability to get feedback from a variety of constituencies and stakeholders in order to develop unique solutions - Ability to assimilate input and make quick choices to guarantee faultless performance

Education/Experience
  • An advanced degree in a health sciences related field is required, with PharmD, PhD or MD, or geographic equivalent, preferred.
  • An advanced degree in a health sciences related field is required, with PharmD, PhD or MD, or geographic equivalent, preferred.
  • 8-10 years in Medical Affairs, Clinical Research within a biopharmaceutical industry setting is preferred.
  • Medical Evidence Generation Operations team leadership experience is desired.
  • A working knowledge of research methodology and how to apply it to medical research planning is desired.
  • A thorough awareness of the major international legislation guiding human research
  • Outstanding interpersonal, strategic, and negotiating abilities
  • Ability to anticipate and resolve challenges in advance
  • Ability to lead multidisciplinary, multi-regional matrix teams in decision-making
  • Diplomacy and good persuasion skills

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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