- Expiry Date: 15 August 2021
The Specialist/Sr. Specialist, GRM Inspections and Audits reports to the Associate Director, GRM Inspections & Audits and is based in either Summit NJ, Princeton Pike, NJ, or Uxbridge UK.
This role will be responsible for coordination and project management activities related to supporting Local Markets compliantly implementing product Risk Management Plans (RMPs) including additional risk minimization measures (ARMM) commitments; supporting the GRM internal audit program; ensuring implementation of Corrective Actions/Preventative Actions (CAPAs) and managing timelines; collaborating to maintain a failure investigation process and assisting with development of GRM related procedural document updates. This individual contributor will serve as Liaison with external GRM vendor audits to ensure implementation of CAPAs and proactively managing timelines to ensure completion and support the Associate Director, GRM Inspections & Audits in relation to Quality Processes projects, as needed.
Responsibilities will include, but are not limited to the following:
Participate and support departmental audits and inspections, including developing responses to audit observations and oversight of corresponding Risk Management action plans. This includes supporting overall audit and inspection readiness activities for GRM and other related continuous improvement initiatives impacting GRM
Manage and provide project management support from end to end including project oversight activities related to the transition of REMS procedural documents to Worldwide Patient Safety (WWPS) Quality Management System (QMS). Utilize project management skills to ensure high quality deliverables are provided in a timely manner.
Collaborate with cross functional teams to assist with the assessment and/or development (e.g., drafting, updating, etc.) of procedural documents, as needed.
Liaise with GRM stakeholders to support the development and maintenance of GRM related procedural documents
Organize and manage the review and drafting of planned amendments (deviation) documentation for GRM stakeholders and partner with GRM TA Leads, WWPS PV Process Excellence and Learning Strategy, and R&D Lifecycle Management groups to ensure and enable appropriate review and approval. Facilitate meetings with stakeholders to resolve and adjudicate review cycles and provide status of deliverables.
Support and ensure the trending and analysis of RM non-adherence data/issues from various sources to identify opportunities for improvement impacting GRM.
Serve as a backup Tier 3 PV Risk Management Quality Council Lead/Coordinator to manage meeting logistics, drafting meeting materials (agenda, minutes, slides) and ensuring upload to GPM repository.
Serve as the primary point of contact to provide PSMF support for RM related updates as required
Partner with management of GRM organization to proactively identify opportunities for process improvement to increase the effectiveness and efficiency of the WWPS organization an represent GRM Inspections & Audits on cross-functional projects within GRM, such as U.S. REMS internal process audits and providing onsite support for FDA REMS inspections.
Assist with providing non-compliance data elements included in the FDA REMS Assessment reports and provide guidance to other data providers to ensure quality and accuracy of data elements
Other responsibilities as assigned
A Bachelor's degree with the minimum years of experience required
A minimum of 5 years pharmaceutical industry experience, and with a minimum of 3 years in pharmacovigilance, drug development, clinical development, or regulatory affairs.
Strong writing experience with development, maintenance, and implementation of policies, procedures.
Excellent and effective verbal and written communication skills with the ability to interacts with senior leadership teams, cross functional project teams and external vendors/parties.
Strong analytical experience with Excel, Tableau, or other BI tools is preferable
Prior quality, compliance and/or audit experience.
Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance.
Successful and creative negotiation of compliance issues.
Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.
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