Head of External Engagement
- To define and implement an external engagement strategy, governance and associated capabilities to ensure that BMS is recognized by regulatory authorities and industry peers as a thought leader in the areas of innovation, science and technology, quality and compliance. Leading a network of company KOLs across GPS that can monitor and influence the evolving external environment and execute internal change where needed based on external signals to continuously improve our products, systems and submissions in service of our patients and company goals and priorities, is a key outcome of the role.
- Ensure that internal processes and strategies are in place to support external representation. Design and implement internal processes and communication mechanisms to assess emerging regulatory expectations for their impact on the company, and to achieve the overall vision and objectives described above.
- Ensure that benchmarking information which is obtained through external engagement is effectively shared within the company and used to continuously improve products, development and manufacturing processes, regulatory submissions and overall quality system.
- Actively engage with regulators and industry peers in industry associations, working groups, activities and topics supporting the implementation of the external engagement strategy and vision for BMS.
This position will report to the Head of Regulatory Compliance and External Engagement, and is an executive level position in the integrated Global Quality Organization.
Major Activities of the role
1. Assess the landscape of major industry associations and joint regulator/industry initiatives to decide where the company must be represented and why, including major impact expected. Ensure that representation covers the executive level for policy setting and strategy as well as the technical subject matter expert level.
2. Design and implement governance processes and cross-divisional/cross-functional governance bodies that support the nomination and participation of internal key opinion leaders in Industry Associations and joint Regulator/Industry initiatives.
3. Ensure that a network of subject matter experts exists and supports the internal key opinion leaders in their external engagement activities.
4. Engage with regulators and industry associations to represent the company on strategic topics.
5. Ensure early identification and assessment of emerging topics/expectations to define the company's strategy and involvement.
6. Ensure effective communication of the outcome of external engagement across the organization, and ensure that there is a close loop mechanism to drive company action and impact where needed to incorporate changes to products and processes, regulatory submissions and quality systems. Ensures that external engagement activities are shared throughout the company, including the company quality council and other business forums across R&D and Global Product Development and Supply (GPS).
7. Ensure timely and effective cross-functional review and commenting on emerging and new regulations/guidelines.
8. Ensure that there is a process in place to assess emerging and new regulations on their impact to the company and support the organization in timely and effective implementation of new requirements. Ensure that a feedback loop is in place and effectively working to integrate such new requirements into the company's products, submissions and overall development and manufacturing processes and quality system. Report on the progress of these activities and their impact to executive leadership in R&D and GPS.
Ensure that external engagement is used to effectively benchmark best practices in the industry to continuously improve products, submissions, and internal development and manufacturing processes and systems.
Desired Expertise of the Candidate
- Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline.
- Languages: Fluent in English (oral and written); additional languages desirable
- Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Quality, Manufacturing and/or Product Development/Regulatory.
- Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, WHO).
- Actively engaged in major industry associations (e.g. EFPIA, PhRMA, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH).
- Highly regarded within regulatory/industry peer groups and recognized as a key opinion leader by major regulatory bodies as a thought leader on Quality and/or Regulatory topics.
- Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
- High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams.
Key Factors to measure success of the role
- An external engagement strategy is defined and implemented (aligned with BMS business imperatives) to ensure that the company is represented across the GxP areas of the product lifestyle in major Industry Associations/Regulatory forums at both the strategy/policy setting level as well as for technical topics, to achieve the overall vision that BMS is recognized as a thought leader in the external environment.
- Internal processes and systems to support external representation are implemented and effectively working.
- Benchmarking results and emerging expectations from external activities are communicated effectively across internal divisions/functions and used to drive action and continuously improve internal products, submissions and quality and scientific processes and systems.
- Through the incumbent's engagement with regulators and industry peers, the reputation of the company is continuously enhanced. The company is involved in strategic initiative with regulators and considered a "go to" organization for benchmarking by peer companies and regulators.
- An internal robust pipeline of talent and external engagement succession planning process is in place to ensure continuous representation in major Industry Associations/Regulatory forums on the strategy and policy setting level as well as for technical topics.
Strategic Importance and Impact of the Global External Engagement Role for BMS
- Achieve the vision to be recognized by Regulatory Authorities as a thought leader in the Industry in the areas of innovation, science and technology, quality and regulatory compliance, and continuous improvement.
- Strategic role to prepare the internal organization for emerging regulatory expectations in GxP areas, across the lifecycle of biopharmaceutical products at BMS.
- High visibility of the incumbent representing the company in major industry initiatives and in interactions with regulators, as well as internal visibility with executive leadership, up to and including BMS executive leadership team members.