Job Description

　　As part of the Global Regulatory Affairs & Clinical Safety (GRACS) Chemistry, Manufacturing & Controls (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). The Associate Director manages a group of operations specialists, provides leadership to individual contributors up to senior-level managers and directors.

　　The incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC dossier structure with demonstrated ability to work with cross-functional project teams.

　　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.

　　Personnel Management

　　Directly supervises the activities of CMC Operations staff.Establishes clear expectations and establishes periodic monitoring of operational and quality performance associated with CMC Operations.Responsible for hiring and training employees, administering all personnel policies and placing an emphasis on Talent Management.

　　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

　　Support the development and design of CMC processes and systems that enable operational activities that will deliver accurate and compliant regulatory information in our Research Division and our Manufacturing Division systems.Identify and communicate gaps in current our Manufacturing Division/ Global Regulatory Affairs and Clinical Safety CMC system/process capabilities;Leverage in-depth knowledge and experience to influence the design of compliant and efficient solutionsAccountable for proactive and timely communication of risks, challenges, and opportunities and addressing them in a systematic and thoughtful mannerProven track record in problem-solving with the ability to make rapid, disciplined decisions, critical thinking capabilities, and work well under pressureThorough understanding of external business and global regulatory environment to enable proactive identification of evolving regulatory expectations that may have an impact on the company and regulatory processes strategyLead/Develop innovative approaches to resolve problems; demonstrate the flexibly to changing priorities or unexpected events. This includes continuous improvement andmaintenance of business processes, tools, systems, metrics, and analytics

　　Qualifications

　　Education Requirement:

　　Bachelor's degree in a relevant discipline

　　Required Experience:

　　Minimum 5 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 eventsDemonstrated ability to recruit, train and develop staff, to motivate others and drive continuous improvement.Capability to effectively manage and deliver against multiple and potentially competing prioritiesDemonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines.Demonstrated ability to generate solutions to problems and effectively work with key

　　stakeholdersCapability 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

　　NOTICEFORINTERNALAPPLICANTS

　　In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

　　If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

　　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:

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　　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.

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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, 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".

　　Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

　　$118,640.00 - $186,800.00

　　Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

　　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:

　　10%

　　Flexible Work Arrangements:

　　Hybrid

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　N/A

　　Requisition ID:R271397