Senior Specialist, Standards
hace 2 meses
**Position Description**: Senior Specialist, Standards & ExecutionThe 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 Senior 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., our Research & Development Division ?Quality Assurance ( 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.
Partners with MRL Learning & Development to ensure alignment between documentation and related training activitiesSupports and manage requests for documentation for GRACS internal audits and inspectionsAdvises project teams and leads on documentation strategy and best practices for addressing impacted procedural documentation for GRACS change initiativesSupports development of process metrics and control plansPosition Qualifications: Education Minimum Requirement: Bachelor's Degree with a minimum of 5 years of Pharmaceutical (clinical, regulatory or safety experience) or equivalent industryRequired Experience and Skills: Proven Project management and organizational skills as applicable to the management of multifunctional global projects.Process improvement mindset.
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.
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 RightsEEOC GINA Supplement?Pay Transparency NondiscriminationWe 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 ActsU.S.
Hybrid Work ModelEffective 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.
**Expected salary range**: $101,100.00 - $159,100.00Available 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,
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