Managing Consultant – Program Manager In Regulatory Affairs

Job Order ID:104
Employment Type:Permanent
Number of Positions:1
Job Location:NJ USA
Brief Description:

Our Client is pursuing an aggressive growth plan to be a disruptive and transformative partner to clients leveraging full service CRO services, FSP services in regulatory, safety and technology along with the enabling domain consulting services and insights from our NETs networks with more than 100 clients.    

Job Function:

  • Lead complex change programs, demonstrate strong program management skills and the ability to drive forward projects
  • Ability to lead cross-functional teams, coordinate with multiple client stakeholders, other vendors, holding others accountable where required
  • Lead a portfolio of consultancy projects to ensure effective delivery of robust consulting and integrated consulting + services solutions
  • Support project teams and clients with insights, with focus on regulatory, pharmacovigilance, and technology
  • Support discussions with senior client stakeholders around industry trends in regulatory and what opportunities and issues can be addressed
  • Deliver projects to client workshops, take the lead facilitation role in delivering the workshop agenda and facilitating the delivery of client agreed objectives and outcomes
  • Influence and act as a change agent, build consensus and manage conflict in challenging situations
  • Work with clients to define requirements, scope projects, prepare business case and statement of work
  • Prepare project management plan, project structure, controls and reporting tools, and routine status reports
  • Manage and track project scope, deliverables, risks, issues, dependencies, documentation and timelines
  • Active leadership in client solutions to build the Client brand – acts as SME on projects and/or Client NETs
  • Leverage relationships to drive selling and marketing of Client’s services to contribute to revenue, pipeline and profitability of programs
  • Manage client relationships ad ensure effective communication, develop solutions, and extend relationships
  • Coach and manage project teams to encourage team work and support development
  • To act as a Client role model to lead company initiatives and collateral development
  • Contribute and drive key initiatives for the practice such as author Thought Leadership publications and white papers, develop new solutions and services
Job Requirement:

  • An advanced degree preferred
  • Minimum 10 years experienced as a consultant in project and program management within the life sciences domain
  • Familiarity with life sciences value chain, industry issues and 5+ years in the regulatory affairs space (e.g., labeling, submissions, publishing)
  • Exposure to PV / Safety, clinical development processes, challenges and products and services
  • Understanding of risk management, quality and compliance in the LS space
  • Honed consulting skills – methodologies/tools, frameworks
  • Compelling communications and proven facilitation skills
  • Strong client and stakeholder management: senior levels, social awareness
  • Excellent project management: manage complexity, resources, profitability
  • Good business development and evidence of BD success through
  • Lead generation and networking
  • Conduct client briefs/senior stakeholder meetings
  • Scoping, requirements, business case definition
  • Development of needs based proposals
  • Negotiation and contract management
  • Account and relationship management
  • Good leadership skills, gravitas, self-starter