Associate Director, Strategic Due Diligence Work (CIA)
Otsuka Pharmaceutical
2021-12-03 08:53:49
Princeton, New Jersey, United States
Job type: fulltime
Job industry: Other
Job description
Position Summary. As a member of the Global Pharmacovigilance (GPV) department, the Associate Director responsibilities include but is not limited to develop and execute the integration strategy of Otsuka affiliates and collaborate with alliance companies working cross-functionally with GPV teams to establish mutual understanding, respect, trust and good communication between GPV and affiliate companies and alliances. Key Job Responsibilities. Collaboration, Integration & Alliances (CIA): Responsible to globalize/harmonize affiliate companies into GPV processes across functional areas and regions through opportunities for increased collaboration. Work cross-functionally within GPV and with collaborating companies to ensure compliance in all aspects of PV. Collaborate and support CIA lead to facilitate discussions on topics identified by colleagues which need creation, improvement and/or harmonization of a process. Collaborate with leadership teams and other necessary stakeholders to formulate a strategy for ongoing success in alliances and execute and facilitate that strategy, by establishing mutual understanding, respect, trust, and good communication between GPV, affiliate and alliance companies. Manage and direct the PV alliance activities that require consensus by working to gain internal alignment and achieve resolution within the alliance while maintaining positive relationships. Escalate issues to GPV CIA lead/management and collaborate with cross functional teams to coordinate and track to resolution in a timely manner. Engage and influence internal & external key stakeholders to drive the strategy, development and continuous improvement processes and services within CIA. Support CIA lead with Business Continuity Plan (BCP) activities for assigned affiliate. Collaborate with Global PV Alliance Management (GPVAM) and Otsuka Alliance Management teams and other key functions. Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes. Perform other tasks as assigned by the management of Global PV. Required Knowledge, Skills, Competencies, Education, and Experience. Knowledge: Knowledge of the interworking's of Global Pharmacovigilance organization is preferred. Extensive knowledge of US, ICH and EU PV and GCP Regulations. Experience and knowledge to assist teams to prepare for and responding to Health Authority Inspections. Experience in process improvement initiatives. Ability to work collaboratively across partnerships. Experience working with Global teams. Skills: Excellent problem solving, strategic decision-making and analytical skills. Strong communication and interpersonal skills. Strong verbal, writing and organizational skills. Demonstrate qualities of competency, accountability, and initiative. Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Knows how/when to apply organizational policy to a variety of situations. Ability to work under pressure to meet tight timelines. Able to work effectively in a matrix environment. Strong attention to detail along with the ability to problem solve. The ability to provide direction to a team, and to influence peers and team members appropriately. Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous priority tasks. Ability to adapt to a dynamic work environment. Education and Related Experience: A minimum of a bachelor's degree is required. RN, NP, PA, PhD or Pharmacist (RPh/PharmD) with 4 or more years of drug safety experience or bachelor's degree in a life science field or equivalent, with 6 years or more of drug safety experience in the pharmaceutical industry. Physical Demands and Work Environment. Occasional teleconferencing at off business hours resulting from meetings being held with US and Japan Approximately 20-30% travel within US, EU, Asia and Japan. Come discover more about Otsuka and our benefit offerings; Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status. Statement Regarding Job Recruiting Fraud Scams. 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