$100K — $150K *
Sumitomo Dainippon Pharma America, Inc. (SDPA) is seeking an experienced, full-time commercial and regulatory law attorney with acumen and drive, together with pharmaceutical/biotech industry experience, to join the SDPA Legal Affairs team as Corporate Counsel in Marlborough, MA.
SDPA supports numerous US and Global affiliates of the Sumitomo Dainippon Pharma Group – including Sunovion Pharmaceuticals Inc., Sumitomo Dainippon Pharma Oncology, Inc. , Sumitovant Biopharma, and their respective subsidiaries by providing professional shared services expertise to achieve greater efficiencies and enable discovery, development, and commercialization of innovative treatments to help patients. The SDPA Legal and Compliance Affairs team is staffed with approximately 35 experienced professionals who provide a broad range of strategic legal and compliance services to each of these affiliates, including Commercial Law, Contracts, Employment Law, Intellectual Property, Corporate Governance, Litigation, and Business Development legal and compliance services.
The Corporate Counsel will be part of a legal affairs team supporting the development and commercialization of the affiliated companies’ robust and growing portfolio of treatments to address serious psychiatric, neurological and other life-threatening conditions.
In this role, you will have primary responsibility for providing legal support for the commercialization of a Sunovion branded product and opportunities to take on responsibility for other in-line or pipeline products. You will also have responsibility for providing advice and counsel in support of research and development activities for the relevant therapeutic area.
You will advise on major brand, commercial, and medical initiatives, including reviewing all commercial and scientific materials generated for that brand to ensure that promotional materials, responses to unsolicited requests for medical information, scientific information (such as posters and abstracts presented at scientific meetings), and publications comply with legal and regulatory requirements. You will be responsible for ensuring that healthcare professional consultants within the therapeutic area are contracted in a compliant manner.
Other responsibilities may include working cross functionally in supporting new product launches and ensuring that pre-approval, market assessment, and disease awareness activities are conducted in a compliant manner, supporting clinical development initiatives, advising on label negotiations in partnership with Regulatory colleagues, reviewing and drafting certain commercial contracts, assisting in overseeing internal and external investigations and litigation matters, reviewing grant and sponsorship requests, supporting market access, pricing, and distribution activities, ensuring that patient support and assistance programs are conducted in a compliant manner, supporting manufacturing and supply chain initiatives, responding to government investigations, and otherwise counseling internal stakeholders to ensure compliance with key healthcare laws, regulations, and guidance, including the Federal Food, Drug & Cosmetic Act, Anti-Kickback Statute, False Claims Act, HHS-OIG guidance, FDA regulations and guidance, and the PhRMA Code on Interactions with Healthcare Professionals.
You will also partner with the Compliance function to continuously assess and mitigate healthcare compliance risks, build strong compliance programs that are consistent with the company’s values and risk profile, and advise on internal policy and process matters relating to the assigned therapeutic area.
Minimum Education, Experience, Knowledge and Skills Required
Valid through: 4/21/2021
$140K — $180K + $15K bonus
2 days ago