Manager Global Development Process & Procedures Operations

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Process & Procedure Operations Manager to join our Global Development team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Remote-USA
• Flexibility & travel: May require up to 25% travel.

What you’ll do:

• Leads/facilitates Process and Procedural Development projects with the respective document owner/Subject Matter Experts, to support development/improvement of the related process (New and Revised).
• Coordinates the development, review, content/comment management and approval of the Procedural Document with the document owner/SME including the writing of the procedural and associated documents, as applicable.
• Initiates and manages cross-functional review cycles ensuring the appropriate SME reviewers.
• Verifies procedural documents do not conflict with other procedures or with regulatory requirements.
• Liaises with the Training function and the document owner to ensure that training requirements are implemented and current within the REGN Learning Management System

This Role Requires:

• Strong Procedural writing experience within the pharmaceutical industry
• Ability to translate operational needs into a process map and procedural document
• Proven ability to work effectively across multiple stakeholders
• Effective communicator (written and oral)
• Ability to work independently
• Proven track record to manage multiple responsibilities and priorities
• Experience in working in or with Pharmacovigilance and knowledge of Regulatory Affairs, Medical Affairs, Clinical Development, Quality, and/or Product Complaints
• Analytical skills with ability to navigate through scenarios
• Experience in procedural document principles, process design, and process improvements is required
• Attention to detail with demonstrated organizational and emotional intelligence/awareness
• Knowledge of Pharmacovigilance regulatory requirements
• Bachelors Degree and 7+ years of relevant experience

Core Behavioral Competencies:

• Strong Microsoft Office proficiency (e.g., Word, Excel, Visio)
• Project Management
• Process Development and Management
• Critical Thinking & Problem Solving
• Stakeholder Management

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$114,800.00 - $187,400.00