Job Detail

Compliance Specialist

Inseriert am: 02.09.2021

Description

Position at Seagen

Summary: 


As a Compliance Specialist you will be responsible for assisting the business functions to empower them to be compliant with complex regulatory requirements by supporting the Legal and Compliance Lead and the Compliance Director with the organization, update and management of Seagen compliance policies, delivery of timely and relevant employee compliance training, coordinating the translation of existing and proposed legislation, regulatory updates and industry practices into Seagen processes as needed, and the collaboration in monitoring processes to ensure they are in compliance with all applicable policies, laws, rules and regulations.  


You will be a member of the Legal and Compliance team, with great chances of developing your career path in Healthcare Compliance in a very dynamic and fast-growing organization. This position will be based in Europe. 
 
Principal Responsibilities: 



  • Design and maintain updated and well-organized systems and records of management decisions, policies, processes, trainings, assessments, remediation plans, investigations, and enforcement actions 

  • Provide advice and guidance to the business on compliance matters, including interactions and practices with health care professionals, government officials, health care institutions and patient associations 

  • Contribute to the conduct of periodic risk assessments to identify and rank risks to help define prioritization of resources and activities 

  • Support designing and executing robust monitoring plans based on periodic risk assessment. 

  • Conduct face-to-face training sessions on compliance policies and processes, design, and update of online compliance training; coordination with other internal training functions as needed, both for onboarding new hires and “refresher” trainings 

  • Drafting of training decks, as well as support the Legal and Compliance Lead and the Compliance Director in the preparation of their internal presentations 

  • Where applicable, partnership and coordination with the Global and Affiliate functions for the disclosure of transfer of value to HCPs and HCOs (transparency). Periodic review of the criteria, the data and adaptation of the Seagen European processes in relation to transparency. 

  • Provide support and advice on the compliance requirements for promotional and non-promotional materials 

  • Partner with other European, Global and Affiliate representatives as needed 

  • Actively follow compliance trends in the market and regulatory environment including in business practices and evolving compliance-related legislation 


Qualifications: 



  • 2/3 years of biotech/pharmaceutical experience in a Compliance role 

  • Genuine care for patients and desire to make a meaningful difference in their lives 

  • Extremely resourceful and smart individual, problem-solver, and self-starter, with the appetite to deliver results while dealing with ambiguity 

  • Comfortable working in a start-up culture: a hands-on, roll up the sleeves approach will be essential. Strong focus on operational skills is required 

  • Convinced and ambassador of the Company Values (Passion for helping patients; Integrity; Scientific excellence; Teamwork and mutual respect; Innovation; Great work environment). 

  • Must be a well-organized, high energy, detail oriented, and persistent team player with the ability to identify / focus on key issues, prioritize efforts, and ensure follow up with timely / quality results 

  • Excellent knowledge of the Microsoft Suite 

  • Excellent communication skills (oral and writing). English is a must; German is a plus 

  • Experience in the DACH (Germany, Austria and Switzerland) region is a plus 

  • University degree a must; a degree in law is preferred 


As a leading employer in our industry, 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. To learn more about Seagen, please visit www.Seagen.com. 
 


Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.   


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