WMA Governance Director Conutry Partnership

Posted 23 November 2021
SalaryNegotiable
LocationBasel
Job type Limited
DisciplineScienceLife Sciences
ReferenceBBBH496437_1637675223

Job description

For our client, a leading pharmaceutical company with headquarters in Basel, we are looking for a:

WMA Governance Director Country Partnership

Tasks:

  • Lead the End-to-End medical governance of evidence generation activities (Interventional studies, NIS/RWE, IIT, MAP, RC) within the assigned geographical area of responsibility
  • Onboard, support, train, coach and mentor country MGLs ensuring that a strong, motivated and knowledgeable team is built within the geographical area of responsibility. Cooperate with operational managers (CSOs/MDOs) in recruitment, onboarding/transition and performance management of MGLs
  • Monitor adherence to Novartis processes and standards within the assigned geographical area ofresponsibilitySupport data quality/integrity in activities conducted within the assigned geographical area of responsibility
  • Provide input to teams decision making, prioritization of initiatives and drive consistent rollout of global medical compliance and governance initiatives
  • Act as the expert and first point of contact for country MGLs of the assigned geographical area of responsibility about MA processes and Novartis standards
  • Maintain overview and monitor progress of quality issues related to the assigned geographical area of responsibility, ensure & track escalation and follow-up until resolution
  • Ensure regular review, assessment and follow-up of key performance, quality, and risk indicators. Support, guide and maintain oversight of country MGLs in implementing and performing MA Health Check process
  • Provide governance updates to Regional Medical Head as required
  • Ensure that compliance gaps and risks are addressed and mitigated by identifying appropriate opportunities for continuous improvement and leading design and implementation of corresponding actions
  • Maintain oversight and monitor local audit & inspection readiness and execution within the assigned geographical area of responsibility, in close collaboration with respective QA function
  • Maintain oversight and monitoring of deviation and CAPA management process for GxP activities, supporting the G/R/C teams in development of robust CAPAs arising from self-identified deviations, audits, and inspections and ensuring that CAPAs are appropriately documented, tracked, monitored, and followed up, and that appropriate action is taken when CAPA is at risk of becoming overdue or being ineffective
  • Maintain operational knowledge of key systems enabling governance processes in order to give advice and guidance to activity owners and country MGLs within the assigned geographical area of responsibility
  • Lead the MGL Network within assigned geographical area of responsibility for ensuring continuous improvement and best practices sharing. Represent the assigned geographical area of responsibility in the global MGL Network/forums. Might lead/co-lead workstream or working group
  • Share common objectives across MGL Network for ensuring a consistent and harmonized governance and training across MA
  • Provide back-up coverage for temporary (vacancies, long-term leave) absent country MGLs and/or for countries with very small volume of activities. Provide a "second pair of eyes" in conflict of roles situations for country MGLs

Requirements:

  • Education: Scientific Degree, PhD, PharmD or equivalent
  • Extensive and relevant experience in Medical Affairs and/or clinical development of medicines (at least 7-10 years)
  • Knowledge and understanding of:
  • Both scientific and operational aspects of clinical drug development and Medical Affairs.
  • ICH GCP and respective national/supranational regulations within the assigned geographical area of responsibility
  • Novartis standard operating procedures
  • Leadership and proven planning and management skills
  • Strong communication and ability to communicate complex information in simple terms.
  • Process excellence
  • Previous experience in a country and/or cluster/regional role required.
  • Strategic thinking and change management mindset to sustain a culture of high ethical standards and compliance.
  • Negotiation and problem-solving skills for bridging between science and business.
  • Proven self-starter with experience in building capabilities based on defined business needs.
  • Able to act independently but actively seek and incorporate stakeholder feedback.
  • Outstanding interpersonal, problem-solving, negotiation and conflict resolution skills. Fast action oriented, capable of quickly identifying contingency plans.
  • Able to influence decision making and drive project teams for outstanding results.
  • Externally focused to ensure full awareness of trends and proactively address needs based on external demands.
  • Proactive and team-player approach for managing effective international and cross-divisional/matrix collaboration.
  • Languages: English - fluent (oral & written)

Workplace: Basel

Workload: 100%

Start Date: 03.01.2022

Duration: 12 months

Your Application:

Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Judith Atgé Martin (+41 61 270 80 16.