Legal Counsel - Blue Earth Diagnostics

Bracco Medical Technologies • Needham, MA

2d • Hybrid

About The Position

About Blue Earth Diagnostics: Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics’ success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging. - Job Purpose Reporting to the General Counsel & Company Secretary, the Legal Counsel will support on legal, compliance and governance matters in a fast-paced and growing company, with a particular focus on commercial contracts. You will advise on a diverse range of matters and there will be plenty of opportunity to take on new challenges and grow in the role. Our teams are set up to work flexibly, therefore the ideal candidate does not have to live near Needham but must be able to travel to the office 3 days a week to collaborate with the team and stakeholders. Main Responsibilities, Activities, Duties and Tasks Advise, review, negotiate and draft agreements including licensing, clinical research, R&D, services, manufacturing, development, distribution, sales, rebate, confidentiality and consulting agreements. Provide proactive, pragmatic legal support on new business initiatives. For example, advising on strategic initiatives and transactions. Proactively identify the need for corporate policies, SOPs, and guidance documents; Provide legal review and counsel for promotional and non-promotional materials, including sales and marketing collateral, scientific exchange, digital media, and disease-state education. Collaborate with Bracco Corporate legal function to ensure consistency and local compliance with Bracco Group initiatives and policies; Drive increased efficiency and effectiveness of legal processes and support to meet the needs of a growing business, including development of standard-form contracts; Provide training on contractual matters and other legal and compliance issues that affect employees. Effectively retain and manage external counsel when appropriate. Assist with activities relating to compliance matters including but not limited to FDA regulations, federal and state fraud and abuse laws, and obligations under U.S. federal health care programs and global Anti Bribery and Corruption and Modern Slavery laws Other duties as determined by business needs.

Requirements

• Juris Doctor (JD) degree from an accredited law school and strong academic credentials
• Membership in good standing of the Massachusetts Bar or other U.S. state bar associations
• 5+ years’ experience supporting clients in the pharmaceutical industry, either in-house and/or a reputable law firm, or a combination of both
• Experience of advising on IP, commercial, data and confidentiality matters.
• Must be willing and able to travel domestically and/or internationally as required by business needs
• A team player with excellent oral and written communication skills.
• Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Highly organized and accustomed to balancing and prioritizing many different tasks.
• Comfortable operating independently with the highest integrity and ethics, but also enjoy being part of a highly supportive and collaborative team
• Drive issues to closure and hold self and others accountable for achieving results
• A proactive, can-do approach and strong commercial acumen with the ability to identify risk, risk mitigations and present suitable options to the business balancing risk and reward.
• Strong attention to detail, providing highly pragmatic legal advice in the context of company strategy.
• Knowledge of FDA requirements and PhRMA Code
• Ability to integrate and work in cross functional network
• Demonstrated project management ability
• Excellent oral and written communication skills and interpersonal skills
• Ability to travel up to 70% (approx.10-12 overnights per month)
• Valid driver’s license
• Excellent oral & written communication skills.
• Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Strong coaching, facilitation, and organizational skills; team player.
• Experience and skills with cross-functional and highly matrixed organizations.

Nice To Haves

• Experienced in compliance, intellectual property and data privacy matters
• Knowledge of drug discovery, development, commercialization and regulatory frameworks within the biotechnology and pharmaceutical industries.
• Knowledge of the PhRMA Code code with respect to promotional and non-promotional activities and interactions with healthcare professionals
• Experience of supporting on corporate governance and company secretarial matters (or a willingness to learn)

Responsibilities

• Advise, review, negotiate and draft agreements including licensing, clinical research, R&D, services, manufacturing, development, distribution, sales, rebate, confidentiality and consulting agreements.
• Provide proactive, pragmatic legal support on new business initiatives. For example, advising on strategic initiatives and transactions.
• Proactively identify the need for corporate policies, SOPs, and guidance documents
• Provide legal review and counsel for promotional and non-promotional materials, including sales and marketing collateral, scientific exchange, digital media, and disease-state education.
• Collaborate with Bracco Corporate legal function to ensure consistency and local compliance with Bracco Group initiatives and policies
• Drive increased efficiency and effectiveness of legal processes and support to meet the needs of a growing business, including development of standard-form contracts
• Provide training on contractual matters and other legal and compliance issues that affect employees.
• Effectively retain and manage external counsel when appropriate.
• Assist with activities relating to compliance matters including but not limited to FDA regulations, federal and state fraud and abuse laws, and obligations under U.S. federal health care programs and global Anti Bribery and Corruption and Modern Slavery laws
• Other duties as determined by business needs.

Benefits

• Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates.
• We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, work/life harmony, and generous paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree