Who we are:
EMD Serono a business of Merck KGaA, Darmstadt, Germany; is a leading science and technology company in healthcare, focused on specialty care. The Company has a deep expertise in neurology, oncology, and fertility and endocrinology and a strong pipeline of potential therapies in oncology, immuno-oncology and immunology.
Fertility and Endo Compliance Counsel. As the compliance counsel, you will determine and implement standards of compliance and ethical conduct within the organization, and design, develop and advance compliance training programs and processes that align to the expected organizational standards and ensure compliance awareness is maintained. You will act as a channel of communication to receive and direct Global and local compliance information appropriately and provide escalation and decision-making support on compliance related questions and concerns.
This role will be the primary contact for Fertility, Fertility Technologies, and Endocrinology, key EMD Serono Therapeutic Areas. You will provide; comprehensive compliance support of a key Therapeutic Area, including providing day to day feedback for Marketing and Sales Operations, Medical Affairs, R&D, Reimbursement, and other activities within the Fertility and Endocrinology Therapeutic Area. You will also provide compliance guidance, feedback and strategic partnership for senior management.
The Compliance Counsel will be a member of the applicable Therapeutic Area Management Team. You will provide; comprehensive legal support of a key Therapeutic Area, including review of marketing materials and advice regarding Marketing and Sales Operations of both pharmaceutical products and medical devices. Comprehensive compliance support of Medical Affairs, including review of scientific (non-promotional) materials and advice regarding Medical Affairs and Medical Operations Proactively identify, and communicate potential compliance issues to mitigate risk. Provide comprehensive compliance support to Therapeutic Area to identify, manage and help mitigate risks including those that involve fraud and abuse and anti-kickback laws. Collaborate with NA and Global colleagues to ensure business strategies and objectives, comply with applicable laws, regulations and policies. Provide advice regarding patient assistance, reimbursement and support programs as well as interactions with patients, including privacy issues. You will also manage other compliance professionals and Paralegals.
Who You Are:
J.D. and bar admission required with minimum of 6-10 year experience in a firm and/or in-house. Pharmaceutical industry experience required, Excellent organizational and communication skills. Ability to work cross-functionally and build consensus among various stakeholders within a global structure while maintaining a compliant approach. Enthusiastic, energetic, self-starter. Strong project management skills. Adaptability and flexibility to changing priorities. Comfortable working and interacting with all levels of management. Initiative, creativity, sense of urgency and strong interpersonal skills. Strong written and verbal communication skills with proficiency in English.