Director REMS Customer Strategy
Location:
Posted:
December 07, 2016
Reference:
16009313-en-us

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Specialty Health, our products and services span the full continuum of specialty patient care. From the initial phases of a product life cycle and the distribution of specialty drugs, to fully integrated healthcare technology systems, practice management support, and ultimately to patient care in the communities where they live, we empower the community patient care delivery system by helping community practices advance the science, technology and quality of care.


We have a vision —that the long-term vibrancy of community care will be achieved through the leadership of physicians committed to clinical excellence and innovation, enabled by close collaboration with our organization and our deep clinical, operational and technological expertise.Every single McKesson employee contributes to our mission—by joining McKesson Specialty Health you act as a catalyst in a chain of events that helps millions of people all over the globe. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.


Join our team of leaders to begin a rewarding career.



Current Need


Position Description
Interprets federal, state and/ or international regulations as they apply to products, processes, practices and procedures. Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and that regulatory reporting requirements are met. Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc. May develop and implement programs designed to increase employee awareness and knowledge of compliance policies. May audit and evaluate current policies, procedures, and documentation for compliance with governmental laws and regulations. May prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.

Qualifications

Minimum Requirements
8+ years of related experience. Desired backgrounds may include healthcare, Medicare, pharmaceuticals, biologics manufacturing, or clinical research.
 
Critical Skills
           
  • Prior FDA Regulatory consulting/guidance experience with Product Landscape Analysis, Submissions, Survey, and Assessments, preferably for REMS programs.
  • Ability to provide strong leadership and influence to matrixed, cross-functional teams in managing multiple projects with conflicting priorities and market imposed deadlines.
  • Strong technical writing, verbal communication and presentation skills.
  • Ability to effectively communicate department objectives and contributions clearly with a proven record of gaining buy-in and support for initiatives from senior management/leaders.
  • Strong ability to adhere to standard methodologies and processes in a highly regulated environment.
  • Strong problem solving skills with the ability to negotiate, arbitrate, resolve conflict and ambiguity.
  • Experience in developing employees through coaching and counseling.
             
Additional Knowledge and Skills
  • Healthcare professional training & experience (RN, Pharm. D, PhD), desirable.
 
Education
MS preferred or 4-year degree or equivalent experience. MBA or MHA degree, preferred.
 
Physical Requirements
            General Office Demands
 
Travel
  • Requires up to 30% travel.
 
Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.
 
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
 
But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
 
McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.
 
Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

Agency Statement
No agencies please.
A little about us:
McKesson is in business for better health.

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