Paralegal

Durham, NC
Full Time
Mid Level
Job Purpose:
We are seeking a highly experienced Contracts and Paralegal Specialist to join our dynamic legal team in a fast-paced, high-volume CDMO environment. This individual will have a demonstrated history of working within the pharmaceutical, biotechnology, and CRO industries, with a strong background in contract management, clinical research, and regulatory affairs. The role requires extensive experience in managing business operations, streamlining processes, and ensuring compliance with privacy laws and industry regulations. The ideal candidate is a resourceful problem solver with excellent communication, collaboration, and risk management skills.

Summary of Key Responsibilities: 
  • Contract Management:
    • Draft, review, and revise a variety of contracts, including master services agreements (MSAs), confidentiality agreements (CDAs/NDAs), quality agreements, and supply/manufacturing agreements.
    • Ensure compliance with company policies and legal standards.
    • Manage the contract lifecycle, from initial review to execution, amendments, and renewals.
    • Maintain contract records and database, ensuring easy access and tracking of contract milestones and key obligations.
  • Legal Support:
    • Assist in the preparation and review of legal documents for various corporate transactions and regulatory matters.
    • Support the legal team in due diligence activities, ensuring compliance with contractual terms and obligations.
    • Research legal issues relevant to the CDMO industry, such as intellectual property, regulatory requirements, and commercial laws.
  • Compliance and Risk Management:
    • Ensure the company's adherence to industry regulations (FDA, EMA, etc.), including Good Manufacturing Practice (GMP) and other applicable standards.
    • Support compliance with data protection regulations (GDPR, HIPAA, etc.) and help implement privacy-related policies and procedures.
    • Assist with audits and regulatory inspections, maintaining proper legal documentation and records.
  • Cross-Departmental Collaboration:
    • Collaborate with business development, project management, and regulatory teams to ensure legal alignment with ongoing client projects.
    • Coordinate with external legal counsel when necessary and act as a liaison between internal teams and outside legal resources.
    • Provide training on contract processes and legal best practices to internal teams.
  • Document Management:
    • Maintain organized legal files and documentation, ensuring confidentiality and proper archiving.
Required Skills and Qualifications:
  • Education: Bachelor's degree required. Paralegal certification preferred. Regulatory Affairs Certificate (Medical Device/Pharmaceuticals) or equivalent experience strongly desired.
  • Experience:
    • 5+ years of experience in contract management or paralegal roles within pharmaceutical, biotechnology, or CRO industries.
    • Extensive knowledge of clinical research settings, regulatory affairs, and high-volume contract management.
    • Familiarity with privacy laws (GDPR, HIPAA) and risk management frameworks.
  • Skills:
    • Expertise in contract drafting, review, and negotiation.
    • Strong project management and process improvement skills, with the ability to handle multiple priorities in a time-sensitive environment.
    • Excellent communication, collaboration, and problem-solving abilities.
    • Proficiency with contract management software and legal documentation systems.
Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*