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Job Description

Reporting to the Executive Director, RIIM, this role will be accountable to ensure a holistic Regulatory centric Data Management (RDM) capability and related data centric submissions within GRACS, are implemented and maintained. This role has broad accountabilities for the following:

+ Regulatory Data Management (RDM) Strategy & Regulatory Data Standards Governance

+ Regulatory Compliance and Risk Management for Regulatory Data

+ Direct and Indirect(e.g., partnering with CMC, Labeling, etc) execution activities that support Data-based Submissions (e.g. XEVMPD, IDMP, PQCMC, SPLetc.)

+ Internal & External Stakeholder Engagement and Change Management for Regulatory Data Standards

The complexity of gathering, organizing, and validating structured data is critical for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are complete and consistent. Having a robust Regulatory data management capability is critical to maximise connectivity and data flows across our multiple Veeva Vaults.

This role will enable future proofing of regulatory submissions and ensuring compliance with evolving standards beyond 2025 (i.e. IDMP related activities and submissions to Global Health Authorities). This will result in positioning the Company competitively by streamlining product lifecycle management and helping to accelerate time-to-market. This will also enable building stronger relationships with regulatory authorities through improved transparency and communication.

Whilst leading a direct and matrixed team of employees, contractors and vendors, the role is also responsible for collaborating effectively with other key stakeholders to drive the strategic direction of the RDM capabilities and data centric submissions. The ability to influence and negotiate with key cross functional Leaders is critical. The Senior Director should have strong managerial experience, a high-level strategic understanding of regulatory data governance and master data management principles, dataflows and activities that occur at global and regional level as well as the requisite capabilities that enable execution of time sensitive strategies.

This role has considerable responsibilities as it relates to internal and external stakeholder management. Internally, it is critical to define and convince key stakeholders of the value and criticality of the need for Master Data Management at an enterprise level. This includes fostering a culture of data stewardship and ensuring stakeholder engagement throughout the organization. This involves promoting the importance of data governance and aligning goals across different departments. Externally, this role will be a leader in advocating with trade, consortia and as appropriate with Health Authorities to promote harmonization and adoption of global standards around regulatory data management practices to promote interoperability and efficiencies to benefit both HAs and industry constituents.

Primary Activities include but are not limited to:

+ Data Centric Submissions: Lead the data submissions team that is accountable for the on-time, accurate and compliant submission of XEVMPD deliverables in the EMA region with responsibility of meeting the reporting deadlines and quality measures specified in local SOPs

+ Data Centric Business System Owner Operations: Lead the regulatory data governance and standards team, which manages regulatory data governance and mediation, ownership, and stewardship roles, including business system operations.

+ Veeva ARC: Playing a lead role in the Veeva ARC implementation and ongoing capabilities that support effective regulatory data management practices - ensuring to the widest extent possible interoperability for cross functional decision making and configuration choices.

+ Develop a framework for understanding and managing regulatory requirements related to data governance and RDM. This involves keeping up on changes in regulations across different markets and ensuring that data practices comply with them. Accountable for maintaining a framework for regulatory control vocabularies (e.g. SPOR)

+ Focuson broader data governance rules and mediation in and collaborate closely with other divisional, enterprise and functional data centric teams in the business and IT

+ Define the development of Global IDMP Data strategy within GRACS. Work with key stakeholders to implement the strategy andintegrate the needs and requirements from Cross functional partners ensuring that the right data is captured and structured in a way that aligns with ISO IDMP’s guidelinesand is enriched andmaintained (e.g. eAF and EMA PMS)

+ Represent the Company in international trade association committees and meeting groups associated with Regulatory Data, IDMP and associated regulatory IT/telematics topics (for example EFPIA, PhRMA and ICH groups).As the opportunity arises, take on leadership roles within the trade association committees and represent the industry in meetings and negotiations with health authorities and other stakeholders.

Education:

+ B.S. with 15+ years of industry experience, at least 6 of those in a regulated environment

**Required** :

+ Experience in developing strategies to establish master data management and governance structures in a regulated business environment

+ Knowledge of key regulatory data that is tracked and managed within regulatory, clinical & pharmacovigilance processes

+ Demonstrated ability to collaborate with senior management and information workers on the importance and need for master data management _I_ governance

+ Experience in working within relevant Industry Trade Associations/Health Authorities with the ability to influence topics/outcomes in the best interest of the Company

+ Strong knowledge of regulatory information assets

+ Business system operations accountability experience

+ Experience in understanding complex regulatory information relationships

+ Broad organizational awareness; can work across multiple levels within an organization

+ Project management skills

+ Excellent communication skills

+ Able to operate effectively in ambiguity

+ Strong business acumen

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$169,700.00 - $267,200.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, People Leadership, Product Lifecycle, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Management, Regulatory Submissions, Stakeholder Engagement, Strategic Planning

Preferred Skills:

Job Posting End Date:

06/7/2025

*A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.

**Requisition ID:** R350234