Expoint - all jobs in one place

מציאת משרת הייטק בחברות הטובות ביותר מעולם לא הייתה קלה יותר

Limitless High-tech career opportunities - Expoint

MSD Senior Specialist Standards & Execution - 
United States, New Jersey, Rahway 
480598918

28.07.2024

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

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

In accordance with 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 Contingent Workers apply

US and Puerto Rico Residents Only:

if you need an accommodation during the application or hiring process.

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 aagreement (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”.

Expected salary range:

$68,400.00 - $107,700.00



*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.


08/03/2024


A job posting is effective until 11:59:59PM 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.