Manager, Medical Affairs Operations

2 weeks ago

Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time

Harmony Biosciences is recruiting for a Manager, Medical Affairs Operations our Plymouth meeting, PA location. In this role you will be responsible for supporting the Medical Affairs Operations function through vendor management, budgeting, and project management for the department based on the Medical Affairs strategy. This role will prioritize and prepare project plans, ensure visibility across all key projects, manage project budgets, and ensure timelines and deliverables are achieved.

Responsibilities include but are not limited to:

  • Manage & track progress for ongoing Medical Affairs projects, including developing project charters and plans
  • Plan, implement, and maintain new and existing departmental platforms
  • Oversee vendor management and serve as a liaison between vendors and Medical Affairs staff
  • Collaborate with internal stakeholders including Regulatory Affairs, Clinical Development, and Legal.
  • Process contracts for Medical Affairs and track related deliverables as needed
  • Work with vendors to draft, review, and negotiate agreements (e.g. SOWs, master service agreements)
  • Perform invoice tracking and monthly budget reconciliation
  • Coordinate the development and maintenance of departmental policies and SOPs
  • Identify inefficiencies in current operations and implement solutions
  • Organize and facilitate internal and external team meetings
  • Partner with internal MA colleagues to evaluate and communicate program and platform metrics
  • General support across all Medical Affairs functions

Qualifications:

  • Bachelor's Degree in an allied-health related field
  • 3+ years in the pharmaceutical/biotech industry experience required - Medical Affairs experience is strongly preferred
  • Baseline of medical terminology / pharmaceutical industry experience required
  • Familiarity with Medical Affairs functions and the regulations that govern our interactions.
  • Experience with Investigator Sponsored Studies (Investigator Initiated Studies) is preferred
  • Demonstrated ability to plan, organize, and manage projects from inception to completion.
  • Proficiency in the use of Microsoft Office Suite; experience with MS Project is required
  • Excellent verbal and written communication skills.

Physical demands and work environment:

  • Domestic travel is estimated to be 5% of the time for this position.
  • While performing the duties of this job, the noise level in the work environment is usually quiet.
  • Specific vision abilities required by this job include: Close vision.
  • Manual dexterity required to use computers, tablets, and cell phone.
  • Continuous sitting for prolonged periods.

What can Harmony offer you?

  • Medical, Vision and Dental benefits the first of the month following start date
  • Generous paid time off and Company designated Holidays
  • Company paid Disability benefits and Life Insurance coverage
  • 401(k) Retirement Savings Plan
  • Paid Parental leave
  • Employee Stock Purchase Plan (ESPP)
  • Company sponsored wellness programs
  • Professional development initiatives and continuous learning opportunities
  • A certified Great Place to Work for five consecutive years based on our positive, values-based company culture

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit

Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

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