Senior Manager, Law and Compliance, International

Overview:

The Senior Manager, Law and Compliance, Germany is based in Munich, Germany, and is a key member of the Incyte German team, and Incyte’s International Law and Compliance team.

The role reports to the Senior Director, Law and Compliance, DACH, located in Munich, Germany.

The role will primarily provide legal support on ex-US Regulatory law issues, in additional to supporting defined commercial law issues in Germany. There is the possibility to support other International and global legal, compliance and business projects, as the need arises.

This is an exciting opportunity for a self-motivated, adaptable, open-minded legal professional who enjoys working in a dynamic and collaborative team environment and wishes to be part of a high-performing team in a fast-growing company.

Key Responsibilities:

• Serve as legal and compliance advisor to the German teams, providing analysis and recommendations on applicable matters under review by Incyte.
• Serve as a member of relevant Incyte internal committees, as requested.
• Serve as legal advisor to the Regulatory team for International, the Technical Operations team, and other teams as needs arise, providing analysis and recommendations on all significant regulatory law matters under review by Incyte internationally. Active and collaborative participation with these teams to craft compliant strategies and facilitate commercial opportunities.
• From a regulatory law perspective, ensure and/or provide timely, practical and proportionate advice on at least the following internationally:

o regulatory risks, strategy, and compliance obligations associated with new products, market entries, and strategic initiatives; o negotiations with at least European and national regulatory bodies, inquiries and representation of Incyte in regulatory proceedings; o development, implementation, and monitoring internal compliance policies, procedures, and guidelines to ensure alignment with EU and national pharmaceutical law regulations; o changes in European and national pharmaceutical law and industry standards, assessing their impact on Incyte; o issues of labelling, packaging, patient information leaflets or similar documentation; o pharmacovigilance, quality assurance, any product supply and recalls or issues potentially impacting patient safety;* + loss of exclusivity and protection of clinical data; + training needs and risk mitigation within the organization and developing and arranging and/or presenting training sessions on relevant laws and legal, business or operational issues; and

• decisions, legislation, rulings and policies that may affect Incyte.
• From a commercial law perspective, ensure and/or provide timely practical and proportionate advice on:

o plans, programs, initiatives, engagements, and materials, related to sales, marketing, market access, regulatory, non-promotional education activities, patient engagement, external communications, employment-related issues and external affairs; o promotional materials, sales training materials, product and disease-related communications and related materials; o interactions with patients, healthcare professionals, institutions, payors, regulatory agencies, and other external stakeholders;* + full range of commercial contracts throughout the product lifecycle and those required to enable Incyte activities, including public tenders; + training needs within the organization and developing and arranging and/or presenting training sessions on relevant laws and legal/business issues; + application and maintenance of all authorizations, permits, licenses, contracts, and communication needed for local operations;

• risk assessments and investigations, as needed or requested;
• decisions and legislation that may affect Incyte; and
• support pre-litigation and litigation matters.
• Assess and supervise external legal counsel as appropriate, ensuring advice is timely, cost-effective, actionable and consistently of h