Senior Director, Digital Governance & LMR Lead

Bayer•Hanover, NJ

About The Position

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. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports Medical Governance processes enabling cross-functional teams to be accountable for the delivery of high quality, ethical standards of service. The role combines digital expertise with the provisioning of process consultancy and guidance to cross-functional stakeholders related to their activities. This interplay is an important driver in advancing digitalization in a regulated environment adhering to company policies and standards we well as relevant legislation to protect the interest of patients. The role is responsible for oversight of external communications and digital media. This role via enhanced strategic USMA Governance, proactively oversees the local Legal-Medical-Regulatory approval procedures and ensures maximal effectiveness while mitigating compliance risks. Actively partners with stakeholders to enable optimal decision making, protecting patient safety, license to operate and compliant business conduct. Enables innovation and realization of the full medical value of our products, ensuring progress towards sustained business success.

Requirements

Advanced degree in science-related field (MD preferred, PharmD, 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 day-to-day activities
Problem solving abilities to work effectively with other functional areas and business disciplines which include Medical Affair, Commercial, Safety, and Quality areas.

Nice To Haves

A minimum of 10 years of experience in the pharmaceutical or biological regulated environment, of which, a minimum of (3) years in a regulated function which may include, Medical Affairs, Quality, Safety, or other similar area
Experience in or a strong working knowledge of Medical Affairs/ Digital, LMR/PRT processes, is preferred
A proven track record for leading and facilitating cross-functional improvement teams is strongly preferred
Dynamic Shared Ownership (DSO) skills: Catalyst : Continuously challenge and improve LMR and digital governance pathways, fostering agility and rapid adaptation to digital innovation. Visionary Leadership : Shape long-term strategies for responsible digital media, AI adoption, and external communication aligned with business and medical objectives. Architect : Build robust frameworks for LMR approvals, AI validation, and compliant vendor oversight that sustain excellence. Coach : Enable cross-functional stakeholders to confidently navigate digital and LMR responsibilities through mentoring, training, and inclusive leadership.

Responsibilities

Oversight of External Communication Procedure: 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 of LMR/PRT procedures and activities for compliance and effectiveness.
Oversight of Digital Media: 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.
Oversight and Governance of Artificial Intelligence (AI): 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). Enforce relevant QSDs/LQSDs, documentation and training.
Organization Readiness: Supports and monitor the organization against relevant QSDs/LQSDs and documentation by performing periodic spot checks and/or mock audits. Support the function throughout the audit and inspection process as well as assist with any corrective or preventative actions (CAPAs). Proactively reach out and review the Audit Plans, make relevant organizations aware of upcoming audits and prepare corresponding readiness plans. Identify subject matter experts in key functions relevant to upcoming audit(s) and focus readiness on knowledge of process, relevant QSDs/LQSDs, documentation and interview readiness.
Provides support as needed to the US Partnering & Issue Management organization team-mates 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.