Job Description

　　The Senior Specialist, Global Regulatory Affairs and Clinical Safety (GRACS) Standards & Operations is a member of Business Continuity, Standards & Training (BCST). This role is critical to the success of the GRACS end to end business process operating model.

　　Under the guidance of the Director/Associated Director, BCST, the Standards & Operations is responsible for the planning and execution of operational activities related to GRACS execution and documentation of business process management. The Standards & Operations Sr. Specialist collaborates with stakeholders across the organization to execute standards and strategies to safeguard optimal quality and compliance of GRACS business processes. Routine, active engagement with Leadership across the GRACS organization, as well as collaboration with other internal and external functions (e.g., Quality Assurance, Learning & Development) is required to develop and execute strategies to support ongoing business needs.

　　Core Responsibilities include and are not limited to:

　　Provide centralized project management support for GRACS programs, including program coordination, sync site management, metrics, and reporting.

　　Support of process re-engineering initiatives across GRACS Business Process Owner Network, including participation in strategic planning sessions. Additionally

　　Project manage assigned initiatives.

　　Support development of communication, training and change management plans for these projects.

　　Conducting large and small-scale business impact assessments while working with process owners and functional SMEs to ensure processes meet business and compliance requirements.

　　Collaborate with Business Process Owners and subject matter experts to ensure processes are consistent with current Health Authority (HA) regulations and policies.

　　Work with Process Owners to develop and maintain business process maps, associated documentation, and training for processes or process changes.

　　Support development of process metrics and control plans.

　　Qualifications:

　　Education Minimum Requirement:

　　Bachelor’s Degree with a minimum of 5 years of Pharmaceutical (clinical, regulatory or safety experience) or equivalent industry.Required Experience and Skills:

　　Proven Project management and organizational skills as applicable to the management of multifunctional global projects.

　　Process improvement mindset. Knowledge of process improvement methodologies as applicable to the pharmaceutical development processes, such as Six Sigma, Lean.

　　Strong skills in process mapping.

　　Proficiency in the use and maintenance of Microsoft applications (Excel, Outlook, Word, PowerPoint, Teams and SharePoint).

　　Knowledge of document management systems, version control, document stewardship.

　　Demonstrated teamwork and leadership skills across geographies and organizational levels, including conflict resolution expertise and discretion.

　　Ability to embrace change/improvement and influence others to adopt this mindset.

　　Strong verbal and written communications skills, including global communications.

　　Demonstrated ability to analyze, interpret and solve complex problems.

　　Preferred Experience and Skills:

　　Demonstrated experience in working in a cross-functional environment. Excellent project management, problem solving, and communication skills.

　　Process Management Knowledge (e.g., Yellow belt)

　　Proficiency in NIMBUS, , Change Execution Management, PMP Certification or Equivalent.

　　Familiarity with GXP regulations, quality procedures and SOP execution

　　NOTICE FOR INTERNAL APPLICANTS

　　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.

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　　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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.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.

　　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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

　　EEOC GINA Supplement​

　　Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

　　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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

　　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:

　　$101,100.00 - $159,100.00

　　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 (https://www.benefitsatmerck.com/) .

　　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: R276143