Associate General Counsel, Litigation
Seek an Associate Litigation Counsel, reporting to Vice President, Chief Litigation Counsel.
Assist in:
• Management of worldwide litigation matters to include: intellectual property, products liability commercial,
securities-related, and other business litigation.
• Management of internal investigations.
• Manage outside counsel, advise senior management on pending litigation and on litigation avoidance.
Be responsible for developing and maintaining processes and procedures for managing litigation matters and
investigations
Must have substantial experience in managing electronic discovery.
Associate General Counsel, Commercial
Position reports to the VP and Chief Commercial Counsel for US and Emerging Markets.
Seeking an experienced life sciences lawyer with a solid background in
the commercial side of the biotech, biopharma or pharmaceutical industry. Support the US and Global
Commercial teams; in particular, an established product as well as near-term pipeline product candidates.
Support the US Commercial Operations team and global Medical Affairs.
Responsibilities:
• Serve as strategic business partner to assigned brand teams, as well as serving on promotional review
committee; risk management and mitigation counseling and brand planning management.
• Plan and coordinate in conjunction with Global Commercial Strategic Team as pipeline candidates are
developed and commercial launch planned.
• Support Commercial Operations and Commercial Strategic Sourcing teams:
*Contracting review
*Commercial program implementation and compliance with state laws
• Global Medical Affairs support:
*Coordination with Medical Science Liaisons
*Publication planning
*Medical Information support
• Ideally candidates will have both in-house and law-firm experience and have a strong technical background in
the commercialization of biotechnology/pharmaceutical products, managed markets and reimbursement.
• Experience with collaborations, consortiums and license agreements strongly preferred.
• Experience with government affairs, FDA and EMA regulations a plus.
• Must have excellent interpersonal, decision making and communication skills.
Position reports to the VP and Chief Commercial Counsel for US and Emerging Markets.
Seeking an experienced life sciences lawyer with a solid background in
the commercial side of the biotech, biopharma or pharmaceutical industry. Support the US and Global
Commercial teams; in particular, an established product as well as near-term pipeline product candidates.
Support the US Commercial Operations team and global Medical Affairs.
Responsibilities:
• Serve as strategic business partner to assigned brand teams, as well as serving on promotional review
committee; risk management and mitigation counseling and brand planning management.
• Plan and coordinate in conjunction with Global Commercial Strategic Team as pipeline candidates are
developed and commercial launch planned.
• Support Commercial Operations and Commercial Strategic Sourcing teams:
*Contracting review
*Commercial program implementation and compliance with state laws
• Global Medical Affairs support:
*Coordination with Medical Science Liaisons
*Publication planning
*Medical Information support
• Ideally candidates will have both in-house and law-firm experience and have a strong technical background in
the commercialization of biotechnology/pharmaceutical products, managed markets and reimbursement.
• Experience with collaborations, consortiums and license agreements strongly preferred.
• Experience with government affairs, FDA and EMA regulations a plus.
• Must have excellent interpersonal, decision making and communication skills.
Associate General Counsel, R&D, Legal (Sr. Director/ Director Level)
Seeking an attorney with experience in global regulatory requirements in the bio/pharma industry and a strong
team orientation.
Will work with others on matters relating to regulatory requirements for investigational and approved products,
regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D
and clinical compliance regulations.
The successful candidate will have direct client responsibility in support of a broad range of company R&D
related activity and perform as the dedicated counsel for late stage development programs.
Specific responsibilities may include:
• Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents
• Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate
and advise on label and approval challenges.
• Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global
agencies that may affect our product approvals and marketed products.
• Advise Drug Safety on recent developments in risk management
• Proactively identify and manage risk profile of products in development to be best prepared to prevent and
address clinical trial and post marketing products liability claims.
• Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing
safety commitments.
Seeking an attorney with experience in global regulatory requirements in the bio/pharma industry and a strong
team orientation.
Will work with others on matters relating to regulatory requirements for investigational and approved products,
regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D
and clinical compliance regulations.
The successful candidate will have direct client responsibility in support of a broad range of company R&D
related activity and perform as the dedicated counsel for late stage development programs.
Specific responsibilities may include:
• Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents
• Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate
and advise on label and approval challenges.
• Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global
agencies that may affect our product approvals and marketed products.
• Advise Drug Safety on recent developments in risk management
• Proactively identify and manage risk profile of products in development to be best prepared to prevent and
address clinical trial and post marketing products liability claims.
• Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing
safety commitments.
