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Job Description The Senior Specialist, Global Regulatory Affairs and Clinical Safety (GRACS) Standards & Execution 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, Standards & Execution Lead, the Standards & Execution Sr. Specialist is responsible for the planning and execution of operational activities related to GRACS process execution and documentation of business process management. The Standards & Execution 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., Research Laboratories Quality Assurance (Research and Development Division QA), Learning & Development) is required to develop and execute strategies to support ongoing business needs. Core Responsibilities include and are not limited to:
Supports process re-engineering initiatives across GRACS Global Process Management Model, including participation in strategic planning sessions. Additionally
Project manage assigned initiatives
Supports development of communication, training and change management plans for these projects
Conducts large and small-scale business impact assessments while working with process owners and functional SMEs to ensure processes meet business and compliance requirements
Collaborates with Global Process Leads and subject matter experts to ensure processes are consistent with current Health Authority (HA) regulations and policies
Works with Global Process Leads, and Functional Area Business Process Owners to develop and maintain business process maps, associated documentation, and training for processes or process changes
Collaborates with Document Owners and SMEs to facilitate development of documentation release announcements to impacted stakeholders in support of the implementation of new or revised GRACS procedural documentation. Partners with our Research and Development Division Learning & Development to ensure alignment between documentation and related training activities
Supports and manage requests for documentation for GRACS internal audits and inspections
Advises project teams and leads on documentation strategy and best practices for addressing impacted procedural documentation for GRACS change initiatives
Supports 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., Yellowbelt)
Proficiency in NIMBUS or other Process Mapping Technology, Change Execution Management, PMP Certification or Equivalent
Familiarity with GXP regulations, quality procedures and SOP execution
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. #GRACS #EBRG #EligibleERP 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 , 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: $ 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. 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: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: *A job posting is effective until PM 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. Job Posting End Date: A job posting is effective until PM 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:R
