Seagen

Associate Director Global Compliance Policies Training & Communication

Corporate Functions - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

This position is a blend of complex problem solving, strategic planning, and functional oversight. It requires an experienced professional who is comfortable with developing and implementing the strategic vision and leading day to day operations.

Principal Responsibilities:

General:

• This position will be responsible for drafting and managing the creation of Compliance polices, procedures, work instructions, and related guidance documents
• This position will be responsible for providing legal research and memorandum to the Compliance Team and General Counsel related to changes in the compliance environment
• This position will also be managing the global policy administration process for all policies excluding those that involve Good Manufacturing Practices, Good Laboratory Practice, and Good Clinical Practices
• This position will be responsible for leading the Compliance Training and Communications team

Compliance Policies:

• Oversee and manage Compliance policy projects and staff
• Partner closely with the Compliance team to create and draft Compliance policies that meet company guidance and applicable state, local, and federal laws
• Responsible for ensuring Compliance policies are clear, well written, and easily understood by our employees
• Capable of working directly with executive leadership on policy creation
• Management of recurring Compliance policy reviews and review schedules
• Undertake benchmarking on industry standard related to Compliance policy content when requested

Legal Research and Writing:

• Research complex legal issues related to compliance environment and changes to DOJ/OIG guidance around elements of an effective compliance program
• Evaluate changes in compliance environment and make recommendations to changes in current compliance policies and provide legal memorandum in support of recommended changes

Global Policy Administration:

• Manage the global policy administration process including: ensuring templates and processes are followed, running the policy administration committee, tracking and applying standard review cycles, and applying other standards as needed for proper policy administration
• Lead the global policy administration committee
• Oversee the work of the policy committee administrator
• Create and implement strategic long-range plans for continued policy administration activities

Compliance Training and Communications:

• Oversee global Compliance training program operations including role based training strategy, reporting metrics and key curriculum to compliance leadership, development of strategic plans for future program enhancements, tracking of program spend, and oversight and development of compliance training staff.
• Create and implement strategic long-range plans for continued policy administration and Compliance communications.
• Be informed and knowledgeable regarding current adult learning techniques and research best fit for Seagen.
• Managing the Compliance Cat brand.

Required Qualifications:

• Minimum of 6 years of professional experience
• Minimum of one year of policy writing within a corporate, government, or military setting
• 5-7 years of healthcare compliance experience or related experience working in sales, marketing, medical affairs, or healthcare
• This position requires superior computer skills with MS Word, Excel, Adobe, SharePoint, and other database applications
• Requirements also include the ability to work with limited supervision, superior attention to detail and organizational skills, excellent grammatical and proofreading skills, proven multi-tasking abilities, immediate response to tasks and personnel requests for assistance, strong interpersonal and communication skills, and ability to handle changing priorities if needed in a fast-paced environment.

Education:

• Bachelor’s Degree required
• JD required

Preferred Qualifications:

• Strong customer service orientation Demonstrated ability to consult or advise internal customer or clients with the ability to build strong relationships and influence.
• Knowledge and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG and PhRMA guidelines, healthcare standard operating procedures, federal Sunshine act, federal state marketing disclosure laws, and state price reporting statutes.
• Experience with compliance/monitoring programs in the pharmaceutical or Biotech industry.
• Ability to work with and communicate both verbally and in writing with employees across departments and throughout the company.
• Strong legal research and writing skills.
• Ability to travel up to 3-4 times per year.

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

The hiring pay range for this position is $179,000 to $231,000 per year based on skills, education and experience relevant to the role.   Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 10/07/2022