Governance and Standards Manager - Groton, CT | Biospace
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Governance and Standards Manager

Pfizer Inc.

Groton, CT
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Governance and Standards Manager provides leadership in planning and execution of the Protocol Review Committee (PRC), the Operations Committee (OpCo) Review processes and with the Global Standards Governance Board (GSGB). This role is responsible to support the efficient conduct of governance processes for GPD governance committees and boards and for monitoring the operational effectiveness of the committees and boards through robust set of metrics. This role will report to the Governance Leader and will work closely with the chair of the Global Standards Governance Board (GSGB), the Chairs of the PRC and the Chair of OpCo as well as with the Data and Analysis & Reporting Standards Teams.Responsibilities for governance and board management include but are not limited to the following:

  • In collaboration with the Governance Leader and the Committee Chairs, monitor, develop and implement streamlined processes for effective and timely study protocol development. review and approval
  • Create and maintain governance agenda watch and coordinate review periods with governance and team members.
  • Develop and apply tools and approaches to identify and correct areas of redundancy or weakness in existing or proposed processes for governance and standards.
  • Evaluate content and context of meeting materials to ensure effective interactions; work with teams to resolve discrepancies/gaps.
  • Develop and provide regular reports and recommendations to the Governance Leader to enable assessment of Protocol Review Committee (PRC), Operations Committee (OpCo) and Global Standards Governance Board (GSGB) performance, as well as timely corrective action as appropriate.
  • Maintain and develop the Governance and Board communication tools for users to obtain information enabling efficient review and approval
  • Work with appropriate functional lines to champion, develop and apply robust and efficient methodology to determine the impact of PRC, OpCo and GSGB on efficiency of protocol design
  • Where required, engage governance and board members directly to ensure effective operations
  • Partner directly and effectively with the Data and Analysis & Reporting Standards Teams
  • Oversight, monitoring and consolidation of all issues requests raised weekly related to Pfizer's standards.
  • Create GSGB agenda working directly with the chair, deputy chair and standards team leads, facilitate meeting, and document review decisions.
  • Use own expertise to contribute to and influence discussions pertaining to standards.
  • Interact and partner with relevant subject matter experts and senior leaders to confirm completeness and appropriateness of proposals to modify standards.
  • Coordinate and lead global, cross functional meetings/teleconferences to the extent necessary (e.g. defining requirements) to ensure adequate business and technical review of complex issues raised regarding potential modification to the standards.
  • Baseline current impact to the standards and develops metrics needed to assess the ability of the GSGB to manage and mitigate change effectively; adopt a continuous improvement approach to both process and outcomes.
  • Provide clear and timely communications with study teams and other customers who have open requests and assist them in advancing to resolution as efficiently as practical to avoid any delays to study timelines.


Basic Qualifications

  • Minimum requirement of a Bachelor's Degree in biomedical discipline plus pharmaceutical industry experience (5 or more years).
  • Advanced (M.S., PharmD, PhD) degree or equivalent experience desirable.
  • Project management experience; demonstrated ability to manage multiple competing priorities in with minimal guidance using own judgment and experiences.
  • Candidate should understand the integration of the various disciplines which make up a successful drug development program.
  • Advanced knowledge of and/or experience in multiple drug development disciplines, such as Clinical Development, Project Management, Statistics, Pharmaceutical Sciences, Drug Safety, or Medical Writing.
  • Candidate should be familiar with how the external environment can influence internal strategy and implementation.
  • Understanding of data, analysis and reporting standards and how they are applied within the pharmaceutical industry.

Additional Offer Details:

  • Last Date to Apply for Job: September 18, 2017
  • This job is Pfizer Exempt US Grade: 008 for all locations except New York, NY which is a grade 010
  • Additional Location Information: MA-Remote, New York, NY, Collegeville, PA
  • Eligible for Employee Referral Bonus