Avanir Pharmaceuticals

Senior Manager, Legal (Sr. Paralegal)

Location
Aliso Viejo, CA
Posted
May 29, 2021
Ref
R2603
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Senior Manager, Legal is responsible for managing the R&D legal queue in supporting the needs of Avanir’s global clinical trials in a timely manner. The incumbent must have a solid and thorough understanding of clinical research operations and industry best practices/standards as well as a proven track record of successfully applying such knowledge and practices in a fast-paced industry environment.

Essential Job Functions:

  • Reviewing and revising informed consent forms, clinical trial agreements, and other legal documents related to global clinical trials
  • Performing legal research as needed
  • Liaising with R&D operations teams, regulatory affairs, finance, and other functional groups
  • Tracking progress of activities, providing status updates to internal and external parties, compiling, and analyzing document data, and maintaining historical negotiation information
  • Effectively managing multiple priorities and exerting influence as appropriate to ensure deadlines are completed in a timely manner
  • Work closely with in-house attorneys to ensure compliance with the applicable laws, regulations, and internal policies.
  • Meeting regularly, as needed, with study team members and other internal stakeholders and proactively providing status updates on projects in the legal queue
  • Proactively managing workload in accordance with study milestones and shifting priorities
  • Providing progress updates and recommending solutions to manager; and sharing supported recommendations with other personnel

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education/ Qualifications:

  • BS/BA degree or equivalent experience
  • Paralegal Certification
  • 10+ years of paralegal experience in pharmaceuticals or life sciences industry
  • Superior organizational skills and able to handle a broad range of matters and work efficiently and effectively in a fast-paced environment
  • Effectively handle high-volume and prioritization of tasks
  • Excellent interpersonal and communication skills, attention to detail and multi-tasking skills, and be able to work under pressure
  • Develop strong relationships based on trust with team members
  • Self-starter, detail-oriented, excellent follow-up and organization skills, report writing and presentation skills
  • Demonstrated problem-solving skills.
  • Able to identify opportunities for operational improvements, develop recommendations, and support internal business teams to drive meaningful change.
  • Must show a history of being a self-starter in in anticipating the business owner’s contracting needs.
  • Effective written and verbal communication skills needed to work effectively across departments and with external partners/vendors and customers.
  • Ability to organize and disseminate information efficiently.
  • Proficiency in using Microsoft Office suite: Word, Excel, PowerPoint, and Visio, etc.

Physical Requirements:

This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies.  The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.

Work Environment:

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.

EEO Statement:

As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.  All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination.  Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.

Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a).  These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.