Senior Manager, Global Development Systems

Location
Tarrytown, NY
Posted
Oct 20, 2019
Ref
17474BR
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 Manager Global Development Systems is a key member of the Global Development Systems (GDS) organization and is responsible for providing Business Relationship Management (BRM) to the Regulatory Affairs, Pharmacovigilance and Risk Management business units.

• Participates in driving the strategy and delivery of systems capabilities for Regulatory Affairs, Pharmacovigilance and Risk Management.

• Serves as a Systems Business Partner by translating business needs into delivery of technology capabilities.

• Ensure that technology capabilities are effectively identified, implemented and utilized in GCP and non-GCP environments.

The position requires broad understanding of collaboration and off-the-shelf and platform technologies such as SharePoint, Veeva, Argusand systems in the Regulatory Affairs, Pharmacovigilance and Risk Management business domains. The role participates in planning and delivering system projects for the responsible business function. This individual is self-motivated and, with minimal supervision, can take on complex assignments by combining business analysis and technology skills. He/she must have excellent interpersonal, presentation and writing skill, and be able to interact with internal clients and external partners and vendors to understand the business needs, to formulate the resulting technology demands into actionable solutions, and to implement the technology solutions for business use.

Responsibilities:

• Understands the business issues and data challenges of the Global Development organization.

• Understands the business needs, priorities and challenges of Regulatory Affairs, Pharmacovigilance and Risk Management to contribute to the establishment of the strategy for delivering systems and related service capabilities.

• Works with end users in understanding business needs and implementing creative solutions.

• Align systems and service strategies with business goals and objectives to insure business outcomes are realized.

o Translate those needs into effective and/or improved processes and/or technical solutions or services by coordinating resources from within their function or the associated IT Department(s).

o Contributes to the delivery of business cases and prioritization across the portfolio

o Contributes to the management of supply and demand of IT resources.

o Understands internal Regulatory Affairs, Pharmacovigilance and Risk Management processes, plans, objectives, drivers, and issues, together with external policies and regulations to insure compliance and effective solution / service delivery.

• Contributes to the evaluation of technology solutions favoring "cloud" and "buy" over "build" and ensures appropriate configuration of technologies to meet Regeneron business needs.

• Participates in the execution and governance of the Regulatory Affairs, Pharmacovigilance and Risk Management Systems portfolio and budget

o Contributes to preparation of the IT budget, coordinates with the Program Management Office and IT Finance as needed.

o Provides communications with business stakeholders.

o Serves as a Subject Matter Expert and routinely briefs key stakeholders on different aspects of assigned initiatives.

• Participates in the Plan and Build components of the Software Development Life Cycle including

o Insuring the business outcome is understood

o Documentation of requirement (business, functional, and technical)

o Planning for Go live support and business readiness

• Contributes on complex high-impact projects with experience in or roles such as Business Analyst, Process Designer, Requirements, Technology Assessment and Selection, Technical/Information Architect, System and User Acceptance Testing, System Design, Computer System Validation, Documentation, Change Management, etc.

• Utilizes various tools and techniques in requirements gathering and scope definition.

• Takes on multiple assignments and works independently, with minimal supervision on task implementation.

• Prioritizes and multitasks to ensure assigned tasks are completed on time.

• Partners with QA on ensuring that projects and systems meet the compliance requirements of regulated systems.

• Complies with all Global Development Systems SOPs for Global Development systems.

• Partners with vendors in understanding future releases of software products, keeping abreast of technology trends and applicability to business needs.

• Introduce new innovative technologies to the business.

• Participate in industry groups and forums.

Requirements:

BS/BA Degree with 7-9 years relevant experience. MS degree and 6+ years relevant experience

• Attention to detail and accuracy of work.

• Strong knowledge of SDLC methodologies and CFR Part 11 compliance.

• Expert in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio).

• Strong knowledge of business analysis, system design and producing quality documentation.

• Strong knowledge of technologies such as SharePoint, SAS, Veeva, Oracle, and/or off-the-shelf software products that support the Regulatory Affairs, Pharmacovigilance and Risk Management areas.

• Strong knowledge of tools for collecting and managing Regulatory and Safety data such as Safety Case Processing, Safety Reporting Repositories, Safety Case Intake, Regulatory Information Management, Labeling and Submission Publishing.

• Experience managing IT capability identification, selection and implementation in Regulatory Affairs, Pharmacovigilance and Risk Management.

• Strong knowledge of tools for collecting and managing Regulatory Affairs, Pharmacovigilance and Risk Management data.

• Strong knowledge of industry data standards e.g. CDISC.

• Demonstrated experience integrating data from multiple sources.

• Good problem solving, technical writing and verbal communication skills.

• Ability to effectively manage multiple priorities with a sense of urgency.

• Strong knowledge of SDLC methodologies and CFR Part 11 compliance.

• Strong track record of project management, stakeholder management, budget management and collaboration skills.

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.