Manager, Contract Management (Clinical)

Legal Waltham, Massachusetts


Description

Position Summary:

The Manager, Contract Management, Clinical Division is a key member of our legal team and is responsible for management of legal contracts for the clinical division. The Manager of Contract Management, Clinical Division will be responsible for all contract related activities for clinical operations. Responsibilities include; the drafting, negotiations, and review of clinical contracts in relation to: clinical sites, clinical trials, regulatory, compliance, and consulting agreements and other business and legal documents, including templates or revisions thereto as appropriate.  Also responsible for liability insurance for new clinical trials.


Key Responsibilities Include:

  • Draft, negotiate, and review clinical contracts in relation to: clinical sites, clinical trials, regulatory, compliance, and consulting agreements and other business and legal documents, including templates or revisions thereto as appropriate.
  • Negotiate amendments to the contract, as needed.
  • Ensure flow down of contract terms and conditions as required or applicable.
  • Ensure compliance with federal regulations.
    Provide analysis and recommendations to executive management for complex contractual issues.
  • Analyzes and communicates new laws, regulations and contract/market trends.
  • Provide support to other functional departments regarding the Company's business operations in compliance with Apellis contractual and operational processes, templates, and applicable international, federal, state and local laws and regulations.
  • Assume process ownership for tracking and maintaining all key contract documents, including but not limited to contract approval records, coordinating renewals prior to expiration dates, preparing and documenting amendments.
  • Helps maintain internal legal department files and update legal resources as needed.
  • Prepare various summaries with respect to the status of key customer contracts and other agreements.
  • Other duties as assigned.


Education, Registration & Certification:

  • Bachelor’s degree, or equivalent related experience and Paralegal certificate required.

 

Experience:

  • 4+ years of experience drafting, negotiating, and reviewing contracts, in the biotechnology or pharmaceutical industry preferred. Prior clinical experience preferred.

Skills, Knowledge & Abilities:

  • Comfortable working independently without supervision 
  • Highly organized, results driven, problem solver
  • Advanced Microsoft Work, PowerPoint and Excel skills
  • Superior written and oral communication skills and the ability to work with different levels of management 
  • Ability to manage multiple time sensitive projects and work independently
  • Ability to read, analyze, and interprets technical procedures, or governmental regulations
  • Highly motivated with the ability to be flexible in a fast-paced environment 

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.