Associate General Counsel
We are offering a long-term contract employment opportunity for an Associate General Counsel in the Health Pharma/Biotech industry, located in Warren, New Jersey. In this role, you will be handling various responsibilities including promotional and regulatory review, contract management, and potentially dealing with employment law and data privacy issues.
Job Title: Pharmaceutical Legal Counsel - Regulatory and Contracts Specialist (NJ License Required)Location: Northeastern New Jersey
Schedule: Hybrid (2-3 days in office)
Employment Type: Full-Time/Contract
Pay: $100+/hour (depends on experience)
As Pharmaceutical Legal Counsel, you will play a critical role in ensuring compliance with regulatory and promotional laws while supporting our business success. This role offers a unique opportunity to contribute to high-impact projects in the pharmaceutical space and collaborate closely with cross-functional teams, including marketing, compliance, and HR.
Key Responsibilities:
- Conduct thorough promotional and regulatory material reviews to ensure compliance with FDA and pharmaceutical industry regulations.
- Provide legal counsel on contractual agreements, including drafting, reviewing, and negotiating terms.
- Stay informed on data privacy requirements and provide guidance to teams to ensure compliance with applicable laws such as HIPAA, GDPR, and CCPA.
- Advise on matters related to employment law and ensure personnel policies and practices align with legal requirements.
- Collaborate cross-functionally to identify and mitigate risk by developing and implementing compliant solutions.
- Ensure alignment with state and federal laws, including New Jersey-specific requirements.
Requirements
Minimum Qualifications:
- Active license to practice law in New Jersey.
- At least 7+ years of experience in legal roles within the pharmaceutical or life sciences industry.
- Demonstrated expertise in promotional and regulatory review processes.
- Strong knowledge of FDA regulations and related pharma compliance frameworks.
- Proven experience drafting, reviewing, and negotiating contracts.
- Understanding of data privacy laws and regulations (e.g., HIPAA, GDPR, CCPA).
- Exceptional analytical, communication, and negotiation skills.
- Candidate must have a minimum of 7 years of experience in the Health Pharm/Biotech industry.
- Position requires proficiency in 3M and Adobe Acrobat.
- Familiarity with ATS - Asynchronous Transfer Mode is necessary.
- Experience with Automated City Register Information System (ACRIS) is a must.
- Proficiency in Case Management Software is required.
- Applicant must have a strong background in Appellate work.
- The role requires expertise in Briefing and Civil Litigation.
- Experience in Claim Administration is crucial.
- The ability to handle Complaints effectively is essential.
- Knowledge of Legal Regulatory procedures is required.
- Familiarity with Regulatory Documents in the Health Pharm/Biotech industry is a must.