職位描述
職位描述：
ROLE SUMMARY
The PCH Regional CEP Lead (APAC, LATAM or EMEA) will be responsible for ensuring compliance, usage of the CEP Processes and manage their respective Regional CEP Approval Committee for the regional teams. The role will report into the Sr. Manager, PCH NA Regional CEP Lead.
ROLE RESPONSIBILITIES
? PCH Oversight
o Will provide oversight into the PCH CEP activities for their regions and will share their findings with te NA PCH Regional CEP lead
? Program Owners support
o Provide support to Program Owners in design phase and navigating the CEP process in a compliant manner
o Monitor CEP compliance during the conduct and close-up phases
? Training and Change Management
o Provide thought leadership and periodic CEP updates in Region and Markets or equivalent In partnership with GCO Lead
o Conduct training of key stakeholders in CEP process (e.g. POs, CEP Champions, Vendors, etc.)
o Monitor training compliance in CEP process (e.g. Program Owners, Vendors, etc.)
? Local CEP Committee Management
o Develop the agenda and logistics of the CEP Committees
o Lead the CEP Committees during approval meetings and mediate between the Program Owner and the Committee’s recommendations
o Inform corresponding Regional Committees of the multi-country programs that apply to the country
? Best Practices and Improvement Initiatives
o Identify and communicate to PCH NA Regional CEP Lead best practices and improvement opportunities in the CEP process
o Incorporate best practices and improvement initiatives pushed by the CEP CoE and GCO Regional CEP Lead
o Support Committee in the oversight of key metrics and quality measures
o Review best practices resulting from programs conducted in the region
? Policies and Procedures follow up
o Communicate changes to CP 902 and CP 902a to internal and external stakeholders
o Monitor changes in country regulations relevant to CP 902 and CP 902a and communicate them to PCH NA Regional lead and into the GCO Regional CEP Lead
? Audits, Inspections and Quality Monitoring
o Support countries to be prepared for audits and inspections
o Monitor the implementation of CAPAs defined by MQO (SRQ in US)
o Keep track of CEPs, providing status and trends to key internal stakeholders
o Review of exception reports and follow up with POs for flagged programs until it is solved
o Share CEP quality report results with Local CEP Committee and CMF or equivalent to build CEP awareness
o Participate and be involved in post-audit meetings if findings cover CEPs
? Vendor Oversight
o Support the activities of vendor oversight as needed in partnership with Global Procurement and the CEP CoE
o Monitor Ariba for vendors being on-boarded for potential CEP engagements
o Identify vendors not complying with CEP processes and requirements and define applicable CAPAs
? CEP Issue Resolution and Transition
o Actively resolve outstanding CEP tasks and issues with the correspondent functional areas (e.g. Regulatory, Legal, Compliance, etc.) and the PO
o Support PO transition with the PO Manager to transition CEP ownership, even after the program end date
QUALIFICATIONS
? Bachelor's degree required
? 8+ years experience in the pharmaceutical industry with OTC experience preferred
? Detail-oriented with strong organizational skills and a proven ability to prioritize and work independently to complete quality work on a timely basis
? Strong project management, organizational and excellent platform / communication skills
? Experience in working through a matrix organization
? Ability to work effectively and collaboratively with CEP Center of Excellence and other PCH Regional CEP Leads
PHYSICAL/MENTAL REQUIREMENTS (not all roles will have physical or mental requirements)
Indicate any physical or mental requirements necessary for the performance of an essential function of this particular role. Requirements should be unique to the work being performed in this role and consistent with business necessity. Examples: Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
? Understand the fundamentals of drug safety and risk management (e.g. Adverse Event reporting), CEP processes, policies and procedures and/or compliance background
? Strong analytical skills; ability to analyze information, draw insights and recommend improvements; ability to synthesize problems and develop innovative solutions and strategies
? Strong customer service skills
? Ability to demonstrate strong facilitation and collaboration skills
? Proficient in project management skills
? Proven ability to drive execution of strategies
? Proficient in common technical tools (e.g. Microsoft Office)
? Strong written and oral communication skills
? Strong English language skills
? Ability to manage multiple tasks and work across a matrix organization
