at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
This position is responsible for providing regulatory, contracting, and general legal support to the North American business organization at Incyte, primarily supporting Dermatology Business Unit.
Essential Functions of the Job (Key responsibilities)
* Develop a thorough understanding of and familiarity with the Company's business, products, markets, sales and promotional practices, customers, collaborators, and competitors and apply that knowledge in providing legal guidance and counsel to internal clients.
* Provide day-to-day counseling/advice and contracting support regarding a wide range of activities and programs related to the North American business operations including promotional review responsibilities. Examples of these activities include providing legal support to:
Medical Legal Regulatory (MLR) review
Scientific/Medical Exchange Materials Review and Approval Team (SMMaRT)
Events Oversight Committee
Oversee contract administration for assigned business unit in addition to reviewing and negotiating select contracts including master service agreements, consulting agreements, media, spokesperson, social media influencer, data sharing, and market research agreements; Assist with other contracting-related matters and special projects across the legal function, as determined by business needs.
Review sales and marketing initiatives and provide operational guidance.
* Identify and communicate legal risks associated with business activities; Collaborate cross-functionally to proactively manage risks by understanding business goals and developing solutions with partners to achieve those goals.
* Maintain a deep and current awareness of evolving regulatory and enforcement environment, including FDA and OPDP regulations, advisory comments, enforcement actions and policy developments.
* Handle miscellaneous legal matters as may be assigned by supervisor and/or legal department managers.
Demonstrate leadership within business and legal teams by seeking to improve ways of working with an eye towards gaining efficiencies.
Qualifications (Minimal acceptable level of education, work experience, and competency)
* J.D. degree, as well as membership in good standing of at least one state bar.
* At least 5 years of legal experience, preferably with a pharmaceutical or biotechnology company, or in the life sciences practice group of a law firm.
* A solid working knowledge of pharmaceutical sales and marketing practices as well as the statutes, regulations and guidance documents applicable to these activities (e.g., the Food, Drug and Cosmetic Act, regulations and guidance documents; federal and state anti-kickback statutes, regulations and OIG guidance documents and opinions, PhRMA Code, and related policies and guidelines).
* Strong attention to detail.
* Solid presentation skills, and experience learning new subjects quickly and effectively.
* Able to calibrate risk effectively for clear and consistent decision-making.
* Good general working knowledge of key contracting issues and negotiation practice.
* Ability to manage multiple tasks simultaneously and flourish in a fast-paced environment.
* Ability to interact in a professional manner with employees at all levels of the organization.
* Strong written and verbal communications skills, including the ability to communicate concisely, to integrate legal and business knowledge and to provide balanced advice regarding risks. Proficient with Microsoft Office suite of products.
Ability to travel within the US of up to than 10%.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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