Director in Operations Consulting at PwC specialising in operational efficiency and effectiveness in manufacturing. Analyzing product development lifecycles and enhancing manufacturing processes.
About the role
- Director, Medical Affairs Operations at BridgeBio Pharma managing medical initiatives across the organization. Serving as a liaison between vendors and stakeholders to support the company's goals.
Responsibilities
- Play a key cross-functional role supporting the development, coordination, and execution of strategic medical initiatives across medical affairs
- Serve as a core liaison between external vendors/stakeholders, field medical teams, and internal stakeholders
- Drive medical insights and execution excellence to support the organization’s strategic goals
- Design and manage the Medical Affairs Group’s Operational infrastructure
- Support other key medical affairs activities, such as driving all grants, IITs, and sponsorships
- Be the medical member of the medical/regulatory/legal (MRL) review committee
- Provide project management support to the Medical Affairs organization in alignment with its objectives and strategies
- Own, manage, oversee and update the library of MSL training material, standard response letters, medical presentation material, contracts, publications and other materials
- Manage and own provide operational and functional aspects of congresses, advisory boards, complex meeting planning and execution
- Ensure that timelines, initiatives and resources align with Home Office Medical Affairs and Field MSL objectives
- Develop and maintain a calendar of meetings across programs, including congress and internal meetings
- Liaise with HCPs, and Legal and Contracts teams by submitting and tracking Medical Affairs contracts for timely submission and full execution
- Coordinate the development of Standard Operating Procedures (SOPs) and compliance updates on an as needed basis
- Lead and drive medical affairs in identifying potential investigators and research projects, grants, investigator-sponsored trials (IITs), sponsored study site identification etc.
Requirements
- Advanced healthcare degree, including PharmD, Ph.D., or MD, required
- 7+ years of experience in the field of medical affairs or medical affairs operations
- Experience in rare diseases, especially rare neuromuscular diseases preferred
- 3+ years of project and operations management experience, including at least 3 years in Biotech or Pharmaceutical industry, required
- At least 3 years of active working experience in Medical Affairs organizations and functions (including but not limited to HCP interactions, MSLs, content management, Sunshine Act Reporting, Agency Management, Contract management, KOL/HCP management) required
- Proficient in managing medical affairs operations systems, including Veeva CRM, Veeva Promomats, and document management systems
- Proficient in managing DocuSign, Concur, Coupa, and vendor management systems required
- Knowledge of pharmaceutical regulations, regulatory compliance and quality assurance
- Able to manage department budgets, purchase orders (P.O.s), statements of work (SoWs), and payments on time and with quality required
- Ability to manage simultaneous priorities, changing deadlines, and limited resources required
- High sense of urgency, attention to detail, and commitment to execution required
- Great organizational and prioritization skills
- Excellent communication and interpersonal skills (including networking) highly organized, and detail-oriented required
- Advanced knowledge of Microsoft Office (Word, Access, Excel, PowerPoint, Teams) required
- Communicate to influence facts and logical approaches
- Able to participate in a scientific dialogue with KOLs and researchers
- Travel – 20% time used for travel
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
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