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Director R&D Reg Data Mgmt Expert DSAI
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Director, R&D Data Management Expert, DSAI are to:
This role will be responsible for a holistic approach to R&D data management with an initial specific focus on product and regulatory data. This role has broad accountabilities for the following
Regulatory Data Management (RDM) Strategy & Data Standards Governance,Direct and Indirect (e.g., partnering with CMC, Labeling, etc.) execution activities that support Data-based Submissions (e.g. XEVMPD, IDMP, etc.),Internal & External Stakeholder Engagement for Regulatory Data Management.Bayer is in the process of optimizing the flow of data across R&D functions, processes and systems. This role will be responsible for streamlining and maximizing connectivity of data flows across Regulatory Affairs and Operations, Pharmacovigilance, Clinical and Supply Chain etc. by way product data lifecycle management and compliance with evolving standards beyond 2025. Such streamlining will accelerate time-to-market and equip Bayer for data-based submissions in a future set up. It will also position Bayer competitively by building stronger relationships with internal and external stakeholders through improved transparency and communication.
Leading the creation and execution of a comprehensive data strategy to support regulatory compliance, filings, and reporting requirements and in alignment with organizational goals;Describing and streamlining the data flow from early and late development to production and submissions and other regulatory interactions;Reporting and translating needs of this streamlined data flow into data product requirements to equip the organization for data-based submissions of the future;Optimize the creation of related data products including the use of AI in the management of relevant data and data products;Managing the entire lifecycle of data products e.g. master data, reference data, data models from ideation and development through to deployment, user adoption, and continuous improvement, and as it relates to pharmaceutical data for regulatory reporting and submissions;Defining, implementing, and enforcing data governance frameworks, policies, FAIR data principles (Findable, Accessible, Interoperable, Reusable), data standards (e.g. IDMP), to enhance the quality, efficiency and effectiveness of regulatory operations and pharmaceutical product development and submission activities;Establishing data quality metrics, overseeing data quality monitoring, remediation processes, in the management of pharmaceutical data for regulatory submissions and monitoring;Liaising extensively with internal stakeholders such as Regulatory Affairs, Clinical Development, Pharmacovigilance, Product Supply, Commercial, IT, Data Science, and Quality Assurance and external stakeholders such as data and digital product vendors. Regulatory authorities and other pharma to achieve the ambition of data based regulatory submission;Promoting a data-centric culture, enhancing data literacy across the stakeholder base and championing data-driven decision-making;Co-shape DS&AI and subcluster strategy to ensure capability excellence and act as a mentor for junior colleagues;Staying current with industry trends in data-based submissions and steering organizational efforts for data-based submissions to relevant authorities in key geographies;Understanding the implications of AI and AI related regulations and approaches on regulatory information management and incorporating these in an evolving data strategy.WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
Master's degree in Life Sciences, Information Technology, Data Management, Data Science, Bioinformatics, Computer Science, or a related discipline;Deep understanding of Pharmaceutical R&D business processes (preclinical, Clinical, CMC, Regulatory, PV) and underlying data, procedures, policies and guidelines. A fair knowledge of Product Supply and Commercial will also be essential;Knowledge of the processes leading up to various regulatory packages, regulatory exchanges and data therein;Understanding of global pharmaceutical regulatory requirements, data standards (e.g., IDMP, XEVMPD, SPOR), GxP principles, and 21 CFR Part 11;Significant experience in enterprise level technology setup in R&D- Experience with RIMS and EDC platforms (especially Veeva), and general cloud enabled technologies such as AWS, Databricks etc;Knowledge of data governance frameworks, data quality methodologies, metadata management, data modeling, and data architecture, data catalogs, data modeling, ontologies, knowledge graph technologies;Experience in data/software product management methodologies, including defining vision, strategy, roadmaps, and managing software product lifecycles and using AI in the next generation of data management activities;Demonstrated experience in project management and cross-functional collaboration;Experience with Agile methodologies for process and software development highly desirable;Strong business analysis skills analytical, conceptual, critical and strategic thinking, and smart decision-making and pragmatic solutioning capabilities;Detail oriented, highly structured and well- organized with process-oriented thinking with ability to manage ambiguity in a changing environment;Self-starter, ability to work independently, initiate ideas, contribute these to a globally distributed team based working environment and bring them to a successful implementation;Excellent written and verbal communication skills in English;Collaboration, influencing and stakeholder management skills are paramount;Ability to focus on multiple issues at one time, organize and direct diverse activities in a matrixed and global environment;Proven ability to engage and influence internal and external stakeholders including vendors.
Preferred Qualifications:
12+ years of experience in roles related to R&D information management, data management, data governance, data stewardship, enterprise level technology setup, preferably within the pharmaceutical R&D sector;Experience in management consulting roles.
Employees can expect to be paid a salary between $164,151 to $246,226. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
This posting will be available for application until at least 8/14/2025.
YOUR APPLICATIONBayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.