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Associate Director of Regulatory & Medical Affairs

Alpha Consulting Lawrence Township ,NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
ASSOCIATE DIRECTOR OF REGULATORY & MEDICAL AFFAIRS
LAWRENCE TOWNSHIP, NJ

Project Description:
Independently and proactively leads a matrixed cross-functional medical project management team within US Medical Affairs, spanning across both Oncology and Innovative Medicines. This role will be a strategic and operational portfolio partner for the medical lead and team in identifying, planning, risk identification/mitigation and delivering on key portfolio related priorities. This includes supporting and partnering on key portfolio processes supporting Medical. Examples: data generation related ideation, prioritization (ISRs, Client sponsored NRDG, HEOR), medical planning, annual portfolio budgeting, and portfolio governance/decision making. The role will partner across key strategic/operational functions across the matrix (GCO, finance, development project management, business operations) to support One Medical Voice, prioritization and decision making. Leading program/projects with passion, innovation, speed and accountability.
  • Partner strategically with the Head, Oncology External Medical Affairs and Medical Team (MT) Leads in her group to facilitate the development and execution of Medical Plans for assigned products and collaborations. Ensure Medical Plan is aligned with TA portfolio objectives/strategies.
  • Drive transparency of the NRDG/ISR book of work, including decision making and support operational improvements in that space by partnering with the NRDG leads.
  • Direct the activities of multi-disciplinary groups to meet the strategic objectives and implementation milestones outlined in the Medical plan(s).
  • Maintain Medical plans and manage dependencies across functions and provide transparency to medical leads and senior leaders. Prepare comprehensive project plans and progress reports for team leads, senior management and other stakeholders, as needed.
  • Track & measure performance and identify risk areas or barriers impeding successful execution. Work with teams, Medical leadership, and/or senior management to resolve.
  • Partner with Medical Team Lead/core team to facilitate medical matrix team meetings, ensure the agenda is focused on key deliverables, risk management, issue identification and resolution. Ensure that key actions and agreements are understood and the team is held accountable for their commitments.
  • Partner with Finance to facilitate the budget process including trade-off discussions and on an ongoing basis ensure the brand budgets (including facilitation of annual budget, monthly projections, accruals, and variance analysis) are on track.
  • Identify, develop and implement new processes to facilitate continued evolution of the Operations function and improve efficiency of the Medical organization.
  • Build relationships with key stakeholders, including Development, FDT PMs, Health Economics and Outcomes Research, Commercial and Medical team members, to influence strategic alignment on key Medical objectives.
  • Ensure MT members are fully represented in the decision-making process and knowledge exchange is taking place.
  • Ensure key communication points are captured and disseminated.
  • Train/Onboard of new project managers, junior level support, and/or contingent workers.

Required Skills:
  • MBA, MS, PhD, PharmD or other advanced degree or equivalent experience preferred.
  • Advanced project management skills and relevant experience on matrix management, budget management, metrics and senior leadership communication.
  • 10+ years relevant experience preferred.
  • Ability to develop clear action plans and execute.
  • Ability to build relationships, influence and drive organizational engagement at all levels.
  • Highly effective written/verbal communication and interpersonal skills.
  • Highly organized and motivated individual with the ability to work independently/effectively with cross functional matrixed teams.
  • Comfort with ambiguity, driving change and innovation across a matrix.
  • Experience with drug development, commercialization, healthcare, clinical trial management a plus.


This 3+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindi@alphaconsulting.com

ALPHA'S REQUIREMENT #20-00589
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Alpha Consulting

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Lawrence Township, NJ
USA