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Manager, Commercial and Regulatory Risk - Life Sciences

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization. Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

The Team

Our Regulatory, Risk, & Forensic Operate offering supports clients by delivering Operate services spanning the Regulatory, Risk & Forensic portfolio. We "embed continuous advantage" through domain, industry, technology and process skills to transform and then deliver client business functions that manage risk and deliver value-added outcomes.

Work you'll do

The Manager is responsible for planning and managing IT-Quality projects within an operating construct, including the development and management of staff assigned to projects and supporting the overall operate engagement including managing effective delivery and profitable economics The manager must understand the principals of Quality Management Systems, Validation and Regulatory/Health Authority requirements. Areas of project focus could include:

+ Regulatory compliance

+ Medical and pharmaceutical regulatory review processes, including transformation thereof

+ Deployment of supply chain systems (e.g., SAP S/4HANA, JDE, Veeva Vault)

+ Assessment and remediation of systems and processing in connection with mergers, acquisitions and divestitures

+ Quality Management Systems processes, including transformation thereof

+ Project Management related to the above

We are seeking an individual either with consulting operate experience or with experience working in a related function at a Medical Technology, or Pharmaceutical manufacturer who can make a successful transition to a consulting operate environment.

Required Qualifications:

+ Bachelor's degree required

+ 8+ years' experience in executing validation projects in Medical Technology or Pharmaceutical

+ 5+ years' experience managing operate consulting engagements or the equivalent process within a client environment

+ Strong understanding of the execution of mergers, acquisitions and divestitures in Life Sciences

+ Knowledge and experience with regulations governing MedTech and pharmaceutical activities, including related review and approval processes

+ Understand the end-to-end software development life cycle (SDLC) in Life Sciences

+ Knowledge of regulatory and compliance aspects of business processes across Life Science broadly, to define and implement strategy, design / re-design processes and support technology

+ Experience in Project Management

+ Experience working in a mandated deadline environment and ability to effectively manage multiple client assignments

+ Continually build detailed subject matter expertise and assist in building out the service offerings in Life Sciences

+ Attention to detail; ability to produce client-ready deliverables for a high-level executive client

+ Limited immigration sponsorship may be available

+ Willingness to travel if required 50% for project assignments.

Preferred Qualifications:

+ Experience with implementing large scale IT-Quality projects, broader than execution of validation activities.

+ ERP technology certification (e.g. SAP)

+ Experience constructing and selling consulting operate engagements

+ Extensive experience managing IT Quality projects related to mergers, acquisitions and divestitures within the life sciences sector.

+ Proven track record of leading large, global teams

Information for applicants with a need for accommodation - https://www2.deloitte.com/us/en/pages/careers/articles/join-deloitte-assistance-for-disabled-applicants.html

For individuals assigned and/or hired to work in New Jersey Deloitte is required by law to include a reasonable estimate of the compensation range for this role. This compensation range is specific to New Jersey and takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $113,300 to $188,900.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.