Senior Specialist, Standards & Execution - Global Regulatory Affairs & Clinical Safety (GRACS)

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

NOTICE FOR