Title: Senior Corporate Counsel, Healthcare Compliance
Req Number: zymo-00000670
Location(s): Seattle WA        

Senior Corporate Counsel, Healthcare Compliance
ZymoGenetics, Inc.

At ZymoGenetics, Inc. we discover and develop novel protein therapeutics based on our research and biological insights into key disease pathways. We have developed and market RECOTHROMŽ Thrombin, topical (Recombinant). Other product candidates span a wide array of clinical opportunities that include cancer, autoimmune and viral diseases.

We are seeking a Senior Corporate Counsel, Healthcare Compliance, reporting to the Vice President, Law & Compliance. This position will be responsible for providing strategic legal advice and support to the commercial organization with respect to a wide variety of regulatory and healthcare compliance issues, including advertising and promotion and fraud & abuse issues. Responsibilities will also include providing counsel, training and guidance and acting as a strategic legal partner for the ZymoGenetics business.

Key responsibilities include:
' Provides ongoing advice to Marketing, Medical Affairs and other departments regarding regulatory issues, including product lifecycle management and fraud & abuse (e.g. OIG Guidelines, PhRMA Guidelines, anti-kickback statutes, state and federal laws, etc).
' Provides legal support and guidance for the development of regulatory submissions, and reviews product labeling and labeling supplements prior to submission.
' Reviews and approves promotional and advertising materials, patient materials, web site content, etc for regulatory compliance.
' Reviews and approves educational materials and other communications initiated by the Medical Affairs group.
' Provides legal counsel and compliance advice related to pricing strategy, including antitrust and government contracting matters.
' Provides back-up for colleagues with respect to negotiation, drafting and interpretation of Company agreements.
' Provides legal support for the Corporate Compliance Program, including review and development of policies and training, as well as monitoring, investigations and corrective action.
' Prepares and delivers employee training and communications on healthcare compliance matters
' May provide litigation support relating to healthcare compliance or other issues as needed.
' Monitors the external regulatory and enforcement environment to identify risks and opportunities.
' Oversees the company's records management programs and may supervise records management staff.

How to apply:
ZymoGenetics, Inc. offers competitive employment packages that include employer sponsored healthcare, paid time off for sick and vacation, 12 paid holidays, matching 401K program, stock options, and the opportunity to make an important contribution. For confidential consideration, we invite you to visit the career page of our website to apply online at: www.zymogenetics.com. Please reference the Source Code ZYMO-0670 in the subject line and indicate how you heard about this position. If including a cover letter, please place/paste before the resume. Should you have a disability that requires assistance and/or reasonable accommodation with the job application process, please contact the Human Resources Department at 206-442-6600. ZymoGenetics, Inc. is an equal opportunity employer and encourages applications from women and minorities.

Key success factors include:
' Educational requirements include a JD and admission to practice law in the State of Washington (admission to the State Bar).
' Minimum of 6 years experience practicing law with an emphasis on issues faced by pharmaceutical and/or medical device firms is required.
' Experience practicing regulatory, FDA and fraud and abuse law in-house within the pharmaceutical or biopharmaceutical industry is strongly preferred.
' Experience conducting internal investigations related to regulatory and other compliance issues is highly desirable.
' Excellent oral and written communication skills are essential, as is demonstrated success working effectively in cross-functional groups.
' This position is located at the corporate headquarters in Seattle, Washington.

For consideration, access our