Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director, Head of Medical Review in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director working on the Global Compliance team, you will be empowered to Innovate and Collaborate. A typical day will include:
Inter-acting across R&D, the incumbent will serve as the primary interface within Global PV accountable for establishing, reviewing and coordinating the Global PV compliance strategy with the support of the Head, Global Patient Safety Evaluation (GPSE) Global PV Compliance, Standards and Training and Business Partners Relations. The incumbent will coordinate and work alongside associates accountable for PV compliance strategy worldwide including the US, EU and Japan territories.
Principal responsibilities include:
- Ensuring the compliance activities related to PV inspection/audit readiness for Global PV, coordinating with the US, EU and Japan Compliance leads and partnering with QA to determine internal PV audit areas of focus.
- Ensuring the oversight of the coordination of PV activities, PV SMEs, and PV deliverables during inspections and audits in coordination with the Head, PV EU PV and Affiliate Compliance, EU QPPV and Head, Compliance, Japan PV as applicable
- Develop and propose recommendations based on findings from external and internal inspections and audits worldwide to focus GPSE global Compliance more towards preventive actions to sustain our culture of zero tolerance for late cases (except for Japan and EU/EEA territories).
- Collaborating with QA to ensure timely audit and inspection responses for the PV function and appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) worldwide (except for Japan and EU territories).
- Collaborating with the Global PV functions to ensure compliance tracking processes and inspections and audit procedures/processes are in place that reflect alignment with various regulatory authorities regulations worldwide
- Ensuring that adequate processes are in place to maintain current knowledge of and adherence to Compliance and relevant PV regulations, including evolving changes in the regulations that may impact compliance.
- Participating in talent management strategies such as annual reviews, performance management, succession planning and employee development and retention.
- Lead the global pharmacovigilance compliance group. Compliance
- Leads the development of PV compliance programs and quality tools to enhance global PV quality and adherence to SOPs and regulations audits in coordination with the Head, EU PV and Affiliate Compliance and Head, Compliance, Japan and US PV as applicable.
- Coordinates and collaborates with EU, Japan and US Compliance to ensure
- Harmonized Global PV compliance processes
- Support for inspections at LOC sites
- execution of PV focused and related inspection/audit support globally.
- In conjunction with applicable Quality Assurance groups, ensure PV regulatory inspection and internal audit readiness for dedicated PV or GCP inspections/audits globally focused.
- Ensures that PV Compliance data is readily available for inspections and audit purposes.
- Ensures that all Global PV inspection and audit issues and findings are addressed adequately.
- Ensure appropriate identification of CAPA stakeholders owners within PV.
- Serve as the primary link to QA for escalation of PV CAPA compliance.
- Designs and implements appropriate mechanisms for maintaining and communicating compliance information across GPSE departments and R&D.
- Collaborates with QA and all relevant PV functions in the development and management of CAPA including assessment of root cause and establishment of timeframes.
- Directs and manages execution of compliance activities as defined in a PV quality plan including maintenance, collection, compilation and regular assessment of adequate PV compliance metrics related but not limited to expedited and periodic PV regulatory reporting to relevant regulatory authorities for case processing and aggregate safety reporting, and their timely and adequate distribution to LOCs and PV business partners.
- Develops and implements PV systems in compliance with PV regulatory requirements worldwide in collaboration with the GPSE Global PV Standards
- Collaborates with the GPSE Training group in the development of training strategies to ensure that GPSE processes meet PV compliance regulatory requirements worldwide.
- Escalates issues / problems related to PV compliance to senior management timely and as needed.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
- Bachelors Required. Advance degree preferred.
- Minimum 10 years pharmaceutical or health care related industry experience required.
- Minimum 5 years PV experience with 2 years of additional experience with participation in pharmacovigilance and/or GCP audits/inspections
- Significant pharmaceutical or health care related industry experience required.
- Must have proven experience in global PV environment with additional demonstrable experience in leading support of pharmacovigilance and/or GCP audits/inspections
- In depth knowledge and comprehension of global pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
- Familiarity with inspections and audit procedures
- Works strategically to realise organizational goals
- Critical thinking and decision-making skills.
- Exercise independent judgment.
- Understanding Takeda business needs with global business perspective and professional attitude.
- Demonstrate integrity
- Motivate and empower others
- Work productively in a high-pressure environment
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Knowledge of compliance international Regulations and ICH environment foundations
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
- Project Management abilities
- Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, knowledge of safety database
- Take initiative and autonomous action
- Able to lead teleconferences and meetings
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
- Some domestic and international may be required on an infrequent basis
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.