Sr. Manager GPS Standards & Training
Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 15, 2022
Reporting to the Associate Director of Global Patient Safety
(GPS) Standards and Training, this position is responsible to
establish and maintain procedures and policies to ensure
consistency with regulatory requirements and industry standards,
and to ensure training on those procedures and polices is conducted
throughout the GPS department. Manages development and
implementation of training as well as curriculums for GPS. Makes
critical decisions on complex to highly complex issues regarding
work approach for GPS procedural and training related tasks. Works
independently across multiple areas. Receives general business
direction, as needed. Posesses strong technical and project
management skills. Oversees direct reports, if applicable. In this
role, a typical day might include the following:
- Develop, implement and maintain SOPs, work instructions,
templates, forms, and business practice tools in collaboration with
the Global Development Process & Procedures group as well as
subject matter experts (SMEs) within and outside GPS; this includes
periodic review of procedures to ensure they continue to correctly
describe GPS processes.
- Manage the GPS procedural portfolio to ensure the
pharmaocovigilance (PV) system complies with global safety
regulations for clinical trial and postmarketing
- Drive standardization across GPS processes and training;
support procedural document implementation
- Establish and manage training curricula in collaboration with
- Create and maintain training materials with SME input/support
- Deliver pharmacovigilance training to stakeholders
- Manage AE training for employees, contractors and vendors
- Monitor training compliance for GPS and vendors providing
safety services in partnership with GPS and other SMEs; manage
training compliance metrics
- Generate, contribute to, and manage departmental metrics
- Archive procedural and training documentation including
individuals' compliance with training
- Monitor GPS regulations globally for changes and collaborate
with SMEs to update procedures as necessary
- Provide input on PV requirements (e.g., reporting, training,
archiving records, etc.) for contracts
- Collaborate with and/or manage PV vendors with respect to
procedural and training aspects to support GPS activities and
- Manage initiatives and projects as requested to continuously
enhance the effectiveness and efficiency of GPS processes and
- Collaborates with Global Development Training and Technical
Training, when applicable, to ensure training requirements are
implemented for assigned roles in procedures
- Coordinate the review cycles of assigned procedural documents
and approval workflows
- Facilitate periodic review of training curriculums
- Manage communications related to team deliverables and
- Manage corrective and preventative actions as assigned
- Provide support for audits and inspections as requested
- Perform other duties for GPS as assigned
- Manage and oversee the work of direct reportsThis role might be
for you if:
- Bachelor's degree in healthcare or life sciences; An advanced
degree such as PharmD, RN or BSN is preferred.
- Minimum 7+ years experience in a global Pharmacovigilance/Drug
Safety department is required.
- Minimum of 5+ years experience managing people.
- Must have strong knowledge of global Pharmacovigilance/Drug
Safety regulations and PV Quality Management Systems.
- Proven project management experience.
- Experience managing vendors is desirable.
- Proven track record of forging relationships to promote
collaboration and driving successful projects.
- Ability to influence others.
- Strong organizational skills and writing skills.
- Attention to detail and accuracy of work.
- Excellent communication skills (written and verbal) and ability
to work with people in all levels of the organization and
- Ability to effectively manage multiple priorities with a sense
- Strategic thinker, ability to problem-solve and make
- Self-motivated with the ability to work effectively and
independently in a dynamic environment with ambiguity
- Must possess strong knowledge of pharmacovigilance regulations
and guidelines (EMA, MHRA, FDA, PMDA, ICH).
- Excellent knowledge of Microsoft Office (Word, Excel,
- Advanced experience analyzing data in Excel (e.g., pivot
tables) and utilizing PowerPoint is highly preferred.Does this
sound like you? Apply now to take your first steps toward living
the Regeneron Way! We have an inclusive and diverse culture that
provides amazing benefits including health and wellness programs,
fitness centers and stock for employees at all levels!Regeneron is
an equal opportunity employer and all qualified applicants will
receive consideration for employment without regard to race, color,
religion or belief (or lack thereof), sex, nationality, national or
ethnic origin, civil status, age, citizenship status, membership of
the Traveler community, sexual orientation, disability, genetic
information, familial status, marital or registered civil
partnership status, pregnancy or maternity status, gender identity,
gender reassignment, military or veteran status, or any other
protected characteristic in accordance with applicable laws and
regulations. We will ensure that individuals with disabilities are
provided reasonable accommodations to participate in the job
application process. Please contact us to discuss any
accommodations you think you may need.
Keywords: Regeneron Pharmaceuticals, Inc., Newark , Sr. Manager GPS Standards & Training, Executive , Basking Ridge, New Jersey
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