Risk Management Associate Director

Location
Malvern, PA, USA
Salary
Competitive
Posted
Nov 09, 2017
Closes
Dec 23, 2017
Ref
1532279845
Contract Type
Full Time
Risk Management Associate Director, Research & Development, Risk Management - Malvern, PA

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

+ POSITION SUMMARY: Under the oversight of the Head of Risk Management, PVRM and, in close collaboration with key colleagues in Commercial Business, Medical Information, Clinical Development, Medical Affairs, Legal, Corporate Security, and Regulatory Affairs, the Risk Management Associate Director develops, implements and maintains Pharmaceutical Product Risk Management Plans, including Risk Evaluation and Mitigation Strategies (REMS). The Risk Management Associate Director has may have primary assigned responsibility for the day-to-day management of one (or more) REMS initiatives.

ROLE AND RESPONSIBILITIES:

+ Contribute to the development, implementation, and maintenance of appropriate policies and procedures related to Risk Management for Endo's pharmaceutical drug products that are consistent with the company's legal and ethical obligations.

+ Escalate issues to the Senior Director, Risk Management.

+ Assist with facilitation for Endo's Risk Management Committee for pharmaceutical drug products.

+ Serve as a resource for knowledge about applicable risk management trends, regulations and guidelines.

+ Provide guidance to clinical, new market, specialty generics, and commercial teams regarding need for REMS and what elements are required in similar product programs.

+ Educate company personnel about Endo REMS programs, when necessary.

+ Assist Regulatory Affairs teams with new drug application submissions where REMS will be required.

+ Serve on any intercompany committees required by Endo's participation in product (e.g., mycophenolate) or class (e.g., long-acting opioids) REMS programs, which may include routine overnight travel.

+ Contribute to maintenance of business practices describing REMS development and intradepartmental coordination.

+ Maintain thorough knowledge of the laws, regulations and guidelines pertaining to REMS to ensure compliance and monitor activity in this area.

+ Provide oversight of vendors and others in design, implementation, and management of REMS programs (not including any independent educational activities).

+ Ensure implementation and tracking of all REMS requirements in accordance with FDA-approved REMS.

+ Contribute to periodic assessments and reporting to the Food and Drug Administration (FDA), in conjunction with Regulatory Affairs.

REQUIRED QUALIFICATIONS:

+ PhD, Pharm.D, BSN, MSN or similar healthcare professional.

+ Experience in Regulatory Affairs or Drug Safety specific to REMS is preferred.

+ Experience in data mining/signal detection is highly desired.

+ At least 10 years' experience in the pharmaceutical industry.

+ A background in Project Management or past experience with serving as the lead on a large complex project would be advantageous.

+ Familiarity with US Regulations and Guidance's relevant to pharmaceutical drug product Risk Management (REMS) activities (particularly FDAAA 2007 and FDASIA 2012) preferred.

+ High level of computer literacy, particularly in the use and management of databases.

+ A detailed knowledge of drug development and the various R&D disciplines involved in the overall life cycle of a drug.

+ Endo-wide competencies include: Decision Quality, Functional/Technical Skills, Informing, Mature Verbal and Written Communication and Presentation Skills; Time Management and Planning.

+ In addition, the following abilities are necessary: strong attention to detail in authoring and/or proofing material; establishment of priorities, scheduling and meeting deadlines; to work in fast paced environment with demonstrated capabilities to simultaneously manage multiple competing tasks and demands; and to work independently, take initiative and complete tasks to deadline.

+ Strong project management skills, ability to manage multiple high priorities, identify resource needs, drive to completion, prepare reports, ad evaluate reports.

+ Demonstrated record of accomplished leadership in matrix project environments.

PHYSICAL REQUIREMENTS:

Capable of occasional overnight travel.

Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

*LI-ENDP