Associate Director Regulatory Information Management - Project Manager

Location
Tarrytown, New York
Posted
Apr 19, 2018
Ref
12696BR
Required Education
Other
Position Type
Full time
Position Summary

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:

Responsible for ensuring RIM projects are planned, organized, coordinated, maintained, and executed in a timely manner.
Responsible for project tracking and resource utilization
Responsible for managing Project Teams that are comprised of key internal stakeholders and vendors.
Requires minimal guidance from direct manager.
Functions as a contributor as needed.
Provides support and backup to management as needed.
Will be responsible for supervising staff in addition to implementing employee development plans.

Duties:

Develops and implements project plans, which includes tracking costs, schedules, risks, and performance for managing projects.
Builds Project Team ownership and commitment to project plans.
Leads the Project Team in appropriate decision making through strong judgment and the ability to analyze options and implications.
Actively uses project schedules and other tools to manage scenario analysis to provide Teams with options and provide visibility to risks ahead of time to enable in process management.
Consistently drives Project Teams to completion.
Assists with Regulatory system solution identification.
Assists with developing RFIs and/or RFPs for RIM system projects.
Collaborates with the Regulatory Systems team and key stakeholders.
Assists with proactively researching industry and technology trends that could impact current systems and processes.
Manages project vendors to ensure expectations are being met.
Ensures effective collaboration tools are used by Project Team for efficiency.

Requirements:

14+ Years
Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, etc).
Knowledge of pharmaceutical drug and device development process.
Experience with project management methodologies.
Experience in Regulatory Information Management/Regulatory Affairs/Operations.
Knowledge and practical experience in global submissions and principles of RIM technology.
Knowledge of scientific industry terminology.
Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.).
Ability to lead, manage, and contribute to multiple ongoing projects simultaneously.
Ability to lead, manage, and contribute to improvement initiatives.
Strong knowledge of technical writing is required.
Training or public speaking experience required.
Change management experience preferred.
Knowledge of SDLC methodologies preferred.
Strong knowledge of 21 CFR Part 11 and Annex 11 Regulations.
Ability to engage and influence a variety of stakeholders at all organizational levels required.
Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
Working knowledge of RIM technology solutions (Veeva Vault preferred), eCTD and Non-eCTD publishing systems, submission validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required. Working knowledge of technical writing is preferred.
Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills
May be responsible for supervising staff.

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.

Requisition Number: 12696BR