Process & Procedures Business Partner

Location
Tarrytown, New York, US
Posted
Nov 22, 2018
Ref
13951BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . The Process & Procedures P&P Business Partner for Global Development Regulatory, Pharmacovigilance PV & Risk Management RM is responsible for translating business and regulatory requirements into the delivery of controlled procedural documents. The P&P Business Partner is directly responsible for executing procedural documents that drive quality and compliance within Regulatory, PV & RM . Duties . Strategic Alignment. Understand the business and associated processes within Regulatory, PV & RM and identify the need for new or updated procedural documentation. Identify current process gaps against Regulatory, PV & RM policies and regulations to ensure compliance and propose effective solutions . Relationship Management. Serve as primary point of contact for all Regulatory, PV & RM process and procedure needs. Establish, strengthen and sustain key relationships with Regulatory, PV & RM stakeholders to understand and forecast business needs, priorities, and challenges. Work with stakeholders in Regulatory, PV & RM to review book of work, forecast and set priorities . Procedural Support and Consulting. Accountable for the delivery of on time, high quality procedural documents and performance tools across Regulatory, PV & RM by collaborating with procedural documentation writers/managers, coordinators, and quality managers. Scope and provide oversight for all procedural documentation projects for Regulatory, PV & RM . Continuous Improvement. Liase with Global Development Training and Process Improvement Business Partners to identify, design and implement continuous improvements opportunities within the process development space . Requirements . Ability to think strategically and operationally . Proven ability to work effectively across multiple stakeholders, who may have competing priorities . Effective communicator written and oral . Ability to influence across, up and down the organization . Proven ability to manage multiple complex responsibilities and priorities . Experience as a thought partner and trusted advisor to leaders of the business . Experience in working in or with Regulatory, Pharmacovigilance and Risk Management . Strong leadership skills with demonstrated ability to interface with Senior Leaders and navigate through complex situations . Experience in procedural document principles, process design, and leading process improvements is required . Strong knowledge of GCP and regulatory requirements . Core Behavioral Competencies . Leadership . Executive Presence . Stakeholder Management . Project Management . Process Management . Strategic Thinking . Critical Thinking & Problem Solving . Integrity and Trust . Negotiating . Organizational & Political Savvy . Dealing with Ambiguity & Paradox. BS/BA Degree with 10+ years relevant experience. MS degree and 8+ years relevant experience . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law . LMR, Pharmacovigilance Manager, Quality Assurance, Auditing, Risk Manager, GCP, GCP, Compliance Manager, SOP Process, . Learning and Performance, performance and learning, training and development #LI-LR1