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Associate Director, Process & Procedures - Global Development

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Jul 25, 2022

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Job Details

The Process & Procedures (P&P) Lead is responsible for translating functional business regulatory requirements and industry methodologies to support the delivery of controlled procedural documents.

A typical day may include the following:

Strategic Alignment
  • Understand the business and associated processes within the assigned functional areas and in collaboration with senior collaborators identify the need for new or updated procedural documentation
  • Collaborate closely with functional collaborators, to identify current process gaps for assigned areas against policies and regulations to ensure compliance and propose effective solutions
  • Work with collaborators in assigned areas to review book of work (ongoing and forecasted) to ensure priorities are understood and aligned with P&P Governance
  • Present collaborator documentation requests to P&P Governance for triaging, prioritization and resource assignment, ensuring scope and need to clear
  • Responsible for reporting of metrics and risk escalation to drive compliance

Relationship Management
  • Serve as point of contact for all assigned functional areas process and procedure needs
  • Establish, strengthen and sustain key relationships within assigned functional areas to understand and forecast business needs, priorities, and challenges
  • Lead cross-functional alignment to improve procedural effectiveness

Procedural Support and Consulting
  • Accountable for the delivery of on time, high quality procedural documents and performance tools across assigned functional areas by collaborating with procedural documentation writers, quality managers and coordinators
  • Ensure document scope is maintained; communicating any risks or issues as appropriate
  • Day-to-day tactical and operational management/oversight of procedural development

Continuous Improvement
  • Collaborate closely with Global Development Training and PMO functions to identify, design and implement continuous improvements opportunities within the process development space
  • Identify, prioritize and lead results and timelines to support procedural revisions and content development related to continuous improvement activities

To be considered
  • BS/BA Degree with 10+ years relevant experience or MS Degree with 6+ years relevant experience
  • Demonstrated experience with Clinical trials and process development.
  • Lean/Six Sigma working understanding a plus
  • Ability to think strategically and operationally
  •  Proven track record of working effectively across multiple collaborators, who may have contending priorities
  •  Ability to work independently and influence across, up and down the organization
  •  Proven track record of leading multiple complex responsibilities and priorities
  •  Experience as a thought partner and trusted advisor to leaders of the business
  • Experience in working in or with Clinical Trial Management, regulatory, Pharmacovigilance and Risk Management
  •  Strong leadership skills with demonstrated ability to work with Senior Leaders and navigate through complex situations
  •  Experience in procedural document principles, process design, and leading process improvements is required
  •  Client Focused and attention to detail with demonstrated organizational and emotional intelligence/awareness
  •  Ability to plan, lead and optimize resources across a matrixed organization with multiple projects
  •  Strong knowledge of Clinical GCP and regulatory requirements

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

#GDDOPMJobs

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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