Posted to MedZilla on 3/27/2017


Takeda Pharmaceuticals

US-IL, Sr Manager, Global Regulatory Affairs Business Continuity 1700696-MZ


 
 

OBJECTIVES:
The Sr. Manager, GRA Business Continuity is in charge of teaming with the Director of Business Continuity to support Vendor Management and related Business Continuity activities. Key aspects include: 1) direct engagement with workstreams identified in the business continuity initiative with a focus on partnership engagement and process improvement 2) manage and support operational activities associated with the outsourcing and integration of Regulatory projects with external vendors and associated operating models 3) support the development of key performance indicators and monitor metrics in-line with the assigned operating model.

ACCOUNTABILITIES:

Business Continuity
  • In partnership with Director of Business Continuity, support all activities associated with effectively building and maintaining external third party vendor relationships and ensure alignment with business and regulatory strategies.
  • Support the development and implementation of new or modified policies, processes and procedures and operational support along with internal/cross-functional team members.
  • Partner with Director to identify process and program improvement opportunities and implement them as appropriate.
  • Raise and facilitate resolution of issues identified by stakeholders and support mitigation plans to proactively reduce risk.
  • Assist in supporting Director in the development of internal monthly management reports, metrics dashboards and maintaining executive dashboard as needed.
  • Collaborate with internal and external stakeholders to create clear program goals and creates a plan to achieve them and communicate goals internally for staff awareness of expectations
  • Support the development and implementation of a Future State Partnership Working Model and share best practices across the organization.
  • Continually works with functional owners to identify and implement improvements.
  • Manage and support a network of workstreams designed to facilitate the transition to an embedded partnership model.
Change Management
  • Leads project-based change management initiatives as needed.
Reporting Vendor Performance
  • Assist in the development of internal monthly management reports.
  • Monitor the accuracy and timeliness of all business partners reporting. Ensures that reporting meets needs.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education and Experience Required:
  • Bachelor s degree (or equivalent) required. Masters preferred.
  • 10 + years experience in Pharmaceutical industry, preferably with 5 years in Regulatory Affairs, research and development or quality assurance/compliance.
  • Demonstrated knowledge of pharmaceutical and regulatory affairs requirements and practices
  • Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets
  • Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment
  • Ability to work independently and focus on multiple issues/deadlines simultaneously
  • Ability to critically analyze complex and/or ambiguous information and the impact on products and process.
  • Extensive knowledge of communication theory/practice and Business Change Management
  • Ability to effectively communicate complex issues both verbally and in writing.
  • Experience in the development, implementation and maintenance of a homepages and/or other communication media
  • Facilitator as well as team player with excellent interpersonal skills
  • Ability to negotiate and form consensus among various parties important
Skills and Knowledge Desired:
  • Systems Knowledge extensive knowledge of Communication theory/practice and Business Change Management
  • Regulatory Familiarity knowledge of global regulatory agencies and regulations relative to activities covered in regulatory affairs in order to facilitate communication activities as relevant
  • Industry Knowledge strong understanding of the pharmaceutical industry and pharmaceutical companies operations processes and strategies including Regulatory Affairs processes.
  • Takeda Operations in-depth understanding of Takeda s operating philosophy, structure and methods including a thorough knowledge of the foreign owned parent company and any affiliates. Ability to work effectively with any internal and external Takeda department.
  • Analytical Skills ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.
  • Communication ability to express oneself clearly and concisely to a variety of audiences
  • Team Working - ability to work with team members in a friendly, professional manner.
  • Knowledge Sharing ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use.
  • Interpersonal Flexibility ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
  • Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization.

LICENSES/CERTIFICATIONS:

  • PMP, APR, Change Management (IMA certification) (recommended)
PHYSICAL DEMANDS:
  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:
  • 10%, some international required.



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