Medical & Scientific Affairs Project & Operations Manager (ASP)

Company: Advanced Sterilization Products
Location: Irvine
Posted on: May 14, 2025

Job Description:

The Medical & Scientific Affairs Project & Operations Manager will work under the supervision of the Chief Medical & Scientific Officer (CMO). This role involves providing project coordination expertise to support Medical & Scientific Affairs functions, promoting standard work development, and ensuring MSA projects meet schedules. The manager will interact with personnel across the organization, including Quality, Risk Management, R&D, and Regulatory, as well as customers when needed.
Under limited supervision, general direction, etc., and in accordance with all applicable government laws, regulations, ASP policies, procedures, and guidelines, this position:

• Supports efficient operations, vendor oversight, training, budgeting, reporting, and project support for the Medical Affairs department, ensuring compliance.
  
• Maintains project flow and ensures task deadline delivery for MSA projects.
  
• Assists in planning, executing, and monitoring medical affairs projects, tracking timelines, deliverables, and budgets.
  
• Develops and maintains daily management workstreams and dashboards.
  
• Supports workshops, meetings, and department deadline tracking.
  
• Identifies process improvement opportunities and implements best practices to enhance operational efficiency.
  
• Organizes and coordinates medical affairs events, such as advisory board meetings, conferences, and training sessions.
  
• Coordinates Medical Affairs attendees at scientific congresses.
  
• Participates in executing Medical & Scientific Affairs strategies aligned with Fortive objectives.
  
• Assists in developing and implementing medical information systems and databases.
  
• Maintains and develops the scientific reference library/database.
  
• Manages Investigator Initiated Study (IIS) Program activities, including proposal review, committee meetings, and compliance checks.
  
• Coordinates IIS contract and FMV processes with legal, reviews budgets, and tracks milestones and payments.
  
• Oversees Software and AI tools portfolio for MSA.
  
• Supports medical information generation, including drafting responses to MIR requests.
  
• Collaborates with regulatory, QA, and SMEs to ensure medical information accuracy and confidentiality.
  
• Maintains records related to medical affairs activities, including clinical studies and regulatory submissions.
  
• Conducts literature reviews and supports medical writing as needed.
  
• Willing to travel up to 10% within the USA.
  
  Qualifications
  

• 
  
• Bachelor's Degree in Life Sciences, Healthcare Administration, Nursing, Pharmacy, or related fields.
  
• 5-10 years of relevant project management experience, preferably in medical device or pharmaceutical Medical Affairs.
  
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Keywords: Advanced Sterilization Products, Lake Forest , Medical & Scientific Affairs Project & Operations Manager (ASP), IT / Software / Systems , Irvine, California