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General Counsel Consulting

General Counsel
Consulting
provided
exceptional
service in helping
my organization
recruit for a hard
to fill position.
They did extensive
work on the front
end to understand
our needs and
our culture and
began referring
highly qualified
candidates almost
immediately.

Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company
LLC

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Counsel Jobs > Director, Corporate Counsel Job in Massachusetts > Director, Corporate Counsel

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Director, Corporate Counsel

Refer job# UTBA148975

Director, Corporate Counsel The candidate will partner on a broad range of corporate legal matters for company's commercial and late-stage products and product candidates, including review of advertising, promotional and medical materials, and strategic advice on transactional and contracting matters. Will report to the Vice President, Corporate Legal Affairs. Serve on promotional and medical review teams and partner with Commercial, Medical Affairs and Regulatory Affairs to help ensure compliance, consistency and accuracy in connection with promotional, medical and disease awareness materials, publications, scientific and medical meeting materials, training materials, and materials for advisory boards andmarket research. Provide legal advice related to materials and initiatives from the Patient Services, Patient Advocacy, Precision Medicine and Clinical Affairs teams. Work collaboratively as a member of cross-functional teams to review other external communication materials, including press releases, conference call scripts, social media postings, website content, and webinar materials. Assist with the review of materials used by teams located outside of the US and, as applicable, help supervise outside counsel and manage the related expenditures to stay within budget. Partner with other members of the legal department as requested to establish and implement periodic risk assessments and audits to identify potential areas of compliance vulnerability and risk. Assist with internal investigations and trainings, as requested. Help support transactional, contracting and other business development initiatives, including drafting, reviewing and negotiating agreements and transaction-related documents. Partner with Compliance, Medical Affairs and other colleagues as requested on review and approval of sponsorships, grants and donations. Develop and deliver training to internal teams, as needed. Represent the department on cross-functional teams, company-wide initiatives or committees, and special projects, as assigned. Maintain a working knowledge of applicable laws, regulations, and enforcement actions to identify emerging trends and risks; keep senior management informed of trends and risks, and help implement related policies, procedures and training programs. The candidate should have a J.D. degree from an accredited law school and be a member in good standing of the Massachusetts Bar. Must have 5-8 years of legal experience in the biopharmaceutical industry at a large law firm and/or in an in-house legal department. Prior experience advising on advertising and promotional matters as a member of an in-house legal department of a commercial-stage biopharmaceutical company strongly preferred. A thorough understanding of healthcare laws and regulations and corporate governance issues related to development and commercialization of biopharmaceutical products, including US Federal healthcare program requirements under the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, OIG guidelines and opinions, the Sunshine Act, FCPA, the UK Bribery Act, HIPAA, and GDPR needed. Prior experience with drafting and negotiating collaboration and licensing agreements in the biotechnology industry a plus.

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