Senior Director, Digital Governance & LMR Lead

Senior Director, Digital Governance & LMR Lead

Apply for the Senior Director, Digital Governance & LMR Lead role at Bayer
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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where “Health for all Hunger for none” is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us.

If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

• Acts as LMR/PRT process owner and expert for the local organization, including handling of PRT pathways and escalations.
• Partners with relevant stakeholders to ensure the local LMR procedures are well fitted to organizational needs.
• Identifies process gaps and pain points with a construction mindset to enable constant improvements.
• Continuously reviews LMR procedures and co‑creates towards streamlining along with relevant stakeholders.
• Oversees LMR/PRT procedures and activities for compliance and effectiveness.

• Partner with digital asset owners to ensure fulfillment of digital media requirements as per internal and external regulations.
• Oversee compliant digital media including geo‑blocking, safety and legal notices.
• Digital media are appropriately registered (i.e., SNOW and MIRA).
• Compliance with approval system (Content Factory), approval number visibility and metadata are in order.
• Sets procedures for social media engagement and supports.
• Advice and supports digital asset owners with digital vendor oversight.
• Continuously assesses internal procedures (e.g., QSDs/LQSDs and related policies) for simplification and increased efficiency.

• Partners with relevant stakeholders to assess developments and potential leverage of AI initiatives.
• Participates in the development and configuration of AI including implementation of controls.
• Performs a formal risk assessment based upon the intended use and configuration of AI.
• Reviews the testing/validation of AI.
• Prepares an AI risk mitigation plan (as needed).
• Enforces relevant QSDs/LQSDs, documentation and training.

• Supports and monitors the organization against relevant QSDs/LQSDs and documentation by performing periodic spot checks and/or mock audits.
• Supports the function throughout the audit and inspection process as well as assists with any corrective or preventative actions (CAPAs).
• Proactively reaches out and reviews the Audit Plans, making relevant organizations aware of upcoming audits and prepares corresponding readiness plans.
• Identifies subject matter experts in key functions relevant to upcoming audits and focuses readiness on knowledge of process, relevant QSDs/LQSDs, documentation and interview readiness.
• Provides support as needed to the US Partnering & Issue Management organization cohort on Medical Governance and other relevant topics, systems and processes that allow the organization to simply move forward to be accountable for the delivery of high‑quality, ethical standards of service across the lifecycle of Bayer Pharmaceutical products.

• Advanced degree in science‑related field (MD preferred, Pharm
  
  D, PhD, DO, MSN, PA/NP or closely related areas/discipline) is required.
• Experience working in the pharmaceutical or biological regulated environment within a regulated function which may include, Medical Affairs, Quality, Safety, or other similar area is required.
• Strong combination of training, knowledge and experience in areas of pharmaceutical industry‑related practices and related Federal Code of Regulations.
• Strong analytical, interpersonal, communication, team building, and project management skills are necessary.
• The ability to identify and prioritize the risks of the organization and lead project teams to success.
• High ethical standards in decision making and in…