Associate Director, Shared Services Delivery Model

The SSDM Associate Director role reports to the SSDM (Sr) Director and will partner cross functionally within GRACS and cross divisionally where applicable to ensure the regulatory post-approval operations in scope of SSDM (i.e.: Renewals, Deletions, Mergers, Acquisitions, Transfers, Legal Entities changes, Site name changes, Tender Bids, CPPs, ancillary documents and artwork implementation) are planned, managed, and executed timely and accurately, issues are identified and resolved, and opportunities for improvement of the business processes are pursued. NOTE: Applicants from locations in LATAM beyond those listed will be considered Specific responsibilities include:

• Manages the selected business processes by providing governance, leadership, and end-to-end support (critical business decisions, changes that affect business processes, roles, and responsibilities)
• Serve as the point of contact and acts as a resource for process(es) design and performance.
• Interprets and applies process objectives and performance metrics (establishing a baseline and trending), monitors and reports process performance against metric targets.
• Ensures process documentation updates and periodic revisions.
• Supports training, education, knowledge sharing and communication activities for the process.
• Assess regularly the E2E process and lead or contribute to improvement or re-engineering/ simplification of the business process and related tools.
• Maintains an effective interface with other relevant cross-functional and cross-divisional processes.

• Represents Regulatory in cross functional/divisional projects for the regulatory planning and implementation of Marketing Authorizations Transfers (MATs), legal entity changes, site name changes, mergers & acquisitions, and advice/facilitates product transition plans execution in close cooperation with country regulatory affairs.
• Performs necessary impact assessments on the regulatory information, collects and analyses regulatory intelligence that is required to develop a regulatory transition strategy and integrates it into cross-divisional planning.
• Identifies and reports regulatory risks.
• Drives and oversees regional scheduling and planning activities, ensures high level accuracy, and minimizes disruptions by overseeing the connections between the different stakeholders.
• Secure continuous follow-up & interaction with RAI stakeholders on execution status and on tracking milestones' achievements of the project plans.
• Manages the ongoing GRACS-Partner relationship with a focus on overall service delivery, issue management, resolution, and escalation, change management.
• Defines and tracks the performance of the functional activities and service level targets by the Partner.
• Maintain close and seamless working relations with the other members of the RAI community, RAI HQ teams, Regional and Country teams, Regulatory Operations, and Information Management teams and GRACS functional teams operating in the international space.
• This position will manage a team of regulatory professionals.

Required Qualifications/Experience: Education:

• Bachelor's degree in life science, engineering, business or a related field (ideally pharmaceutical science degree)
• Master's degree (desired)

Requirements:

• Minimum 5-7 years' experience in pharmaceutical industry
• Previous experience in Regulatory Affairs, CMC, compliance management or Quality, working with external partners and/or dealing directly with regulatory agencies is preferred.
• It is recognized that this role will require knowledge of the business and organizational set-up, broad-range experience within and outside of Regulatory Affairs, understanding of Operational Excellence principles, ability to work through the matrix approach in a culturally diverse environment, learning agility, resilience, and emotional intelligence.
• Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
• Strong interpersonal/communication skills and capacity to work across the geographies with the high number of stakeholders.
• Detail oriented, problem solving, ability to accelerate the decision-making process, project management skills (providing guidance to others in task completion and on-time deliverables)
• People management (desired)
• Ability to communicate effectively, both verbally and written, with others across all levels of the organization
• Ability to work in a matrix organization.
• Technology proficient; Interest in new tools or automatization will be needed.
• Innovative mindset and design thinking skills.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE 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 if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 U.S. Hybrid Work Model 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, generally Tuesday, Wednesday and either Monday or 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". 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Requisition ID:R271171