Associate Senior Counsel Job Opening
New Jersey-based Pharmaceutical Company
Description of duties for Associate Senior Counsel:
This attorney’s role is to assist in the management of the legal
affairs of the organizations’ risks and opportunities in a proactive
and collaborative manner, and in the achievement of business strategies
and overall mission. The focus will be primarily on legal matters
impacting the clinical research arms of the organizations(s) and
related functions such as Regulatory Affairs, CQA, Medical Affairs,
Medical Services, MSLs, Clinical Operations. Position is essential to
ensure appropriate support for company activities and initiatives and
to facilitate managerial/operational decision making.
- Advise clients (including study teams, assigned client functions
and management) on various legal, compliance and liability matters;
- Interpret and apply relevant laws, regulations and requirements; dispute management and resolution;
- Risk and liability management in global operations and on day to day activities;
- Advise on contractual matters;
- Address emergent issues and identify systemic concerns and considerations;
- Advise on human subject protection, reimbursement and payment
issues, GXPs, scientific exchange, publication, IP and related rights;
- Coordinate advice of legal experts on critical issues and concerns.
Qualifications for Associate Senior Counsel:
- FDA regulations and guidance, and corresponding state laws relating
to clinical research and development, compliance and liability matters;
- Industry knowledge is required;
- Must have recent prior transactional experience;
- Must have had prior significant client contact and responsibility at various levels;
- Must have very strong writing, speaking, organizational and
analytical skills, excellent contract drafting and significant
pharmaceutical transactional experience.
If you are in the Newark area and interested in learning more about the Associate Senior Counsel job opening, click here to send an email with your resume.
