Job Description

As part of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Operations team, the CMC Operations Associate Director will be accountable for the delivery of Regulatory tools, systems and processes that support CMC regulatory operations needed for all products through the product lifecycle (to include Change Control Management, Regulatory Submission Planning, Content Authoring, and Health Registration Management).

We are seeking a skilled individual to play a vital role in CMC operations team. The ideal candidate will support the Strategic Operation leads and collaborate with various stakeholders to gather, analyze, and document business requirements for systems and dashboards implementation and enhancements. They will work closely with the CMC Operations team and IT teams to translate these requirements into technical specifications, ensuring that the developed solutions align with operational needs. This requires their ability to communicate effectively with stakeholders will be essential, as you will participate in meetings and workshops to clarify team objectives and serve as a point of contact for any inquiries.

In this role, the CMC Operations Associate Director will support the operations documentation by creating and maintaining comprehensive records, including business requirements documents, creating and updating process flows, creating User Acceptance Test scripts and use cases. Additionally, they will work with the strategic ops lead in the planning and execution of system support, supporting efforts among cross-functional teams such as Quality, Regulatory Affairs, Business System owners and IT. Their expertise in testing and validation will ensure that all IT solutions are rigorously tested through the development of test plans, test cases, and user acceptance testing (UAT) scenarios.

They will also assess existing CMC processes and systems to identify areas needing improvement and recommend innovative solutions to enhance efficiency and compliance. Collaborating with the CMC Operations Strategic Leads, they will define data requirements and champion data integrity efforts within CMC systems, ultimately contributing to the success of our operations and the development of high-quality pharmaceutical products. There proactive approach and technical acumen will be crucial in driving positive outcomes in our organization.

Primary Activities:

• Project Management

• Leverage collaborative decision making, problem-solving and substantial stakeholder management skills to deliver exceptional sound business insights, judgements, and decisions.

• Analyze data and provide holistic, end-to-end coordinated assessments, targeting the audience with the necessary level of detail.

• Communication

• Lead activities related to developing, implementing, and delivering change management to appropriate audience across the organization.

• Apply risk management principles and follow escalation process as a way to make problems visible and take appropriate steps to mitigate risks related to People, Safety, Quality, Delivery and Cost.

• Collaborate with leadership and stakeholders to accurately reflect status and with appropriate urgency.

• Operation and System Support

• Design of CMC processes: Support the development that enable operational activities that will deliver accurate and compliant regulatory information in our Research & Development Division and our Manufacturing Division systems.

• Requirements Gathering: Collaborate with stakeholders in CMC operations to gather, analyze, and document business requirements for new system implementations and enhancements.

• Technical Analysis: Translate business requirements into technical specifications, working closely with IT teams to design and develop solutions that meet operational needs.

• Documentation: Create and maintain comprehensive documentation including business requirements documents (BRDs), functional requirements documents (FRDs), process flows, and use cases.

• Stakeholder Communication: Facilitate meetings and workshops with stakeholders to ensure clear understanding of project objectives and requirements. Serve as the primary point of contact for any questions or concerns.

• Testing and Validation: Develop and execute test plans, test cases, and user acceptance testing (UAT) scenarios to ensure that IT solutions meet business needs.

• System Implementation: Oversee the planning and execution of new system startups, including coordinating efforts between cross-functional teams (e.g., Quality Assurance, Regulatory Affairs, and IT).

• Process Optimization: Assess existing CMC processes and systems, identifying areas for improvement and recommending innovative solutions to enhance efficiency and compliance.

• Data Management: Collaborate with CMC Ops Strategic Lead to define data requirements, and drive data integrity efforts in CMC systems.

Qualifications:

Education Requirement:

• Bachelor's degree in a relevant discipline

Required Experience:

• Minimum 10 years pharmaceutical industry experience.

• The candidate must be proficient in English; additional language skills are a plus.

Preferred:

• Knowledge and experience related to change control requirements, regulatory information and supporting business processes and systems. Exposure to regulatory affairs either through direct experience, or via a role in R&D or manufacturing.

• Degree in science, engineering, or a related discipline; post-graduate degree preferred.

Skills:

• Demonstrated leadership and management experience working with cross-functional teams on complex projects.

• Examples demonstrating the ability to work in ambiguous situations, formulate a plan, focus on what matters, drive outcomes, and speak up and be open-minded.

• Demonstrated experience in problem solving in an operations setting (manufacturing, systems, etc.) enabling process improvements or process/system deployment.

• Broad knowledge in CMC/regulatory activities across product development, registration, and life-cycle management.

• Demonstrated sound understanding of related fields (e.g., manufacturing, information management, quality assurance) and the ability to be creative and innovative in the

• approach to new and diverse problem solving.

• Demonstrated interpersonal, verbal communication, written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams.

• Demonstrated ability to generate innovative solutions to complex regulatory problems and

• effectively work with and communicate to key stakeholders.

• Demonstrated flexibility in responding to changing priorities or dealing with unexpected

• events

• Capability to effectively manage and deliver against multiple and potentially competing

• priorities

• Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines.

• Demonstrated ability to generate solutions to problems and effectively work with key stakeholders

• Capability to work effectively in matrix organizational structures.

• Demonstrated flexibility in responding to changing priorities and adapting to unexpected events by identifying innovative ways to achieve high quality, compliant deliverables.

• Familiarity with CMC related CTD structure and content

Current Employees apply HERE

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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:

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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, 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".

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

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R325295