Avanir Pharmaceuticals

MLR Specialist

Location
Aliso Viejo, CA
Posted
May 21, 2021
Ref
R2645
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The position of MLR Specialist will be a critical part of the Medical, Legal, and Regulatory (MLR) process. This individual will facilitate the end-to-end management of all aspects of the Commercial as well as Non-commercial review and approval process, including planning, prioritization and coordination of Commercial and Non-Commercial activities in Veeva.

Essential Job Functions:

  • Serve as a gatekeeper and coordinate all MLR activities to ensure efficient and quality process.
  • Work with functional teams, i.e., Marketing, Medical Affairs, Sales Training, R&D and Public Relations, to plan and prioritize the review of materials; assist with planning from uploading for review through distribution of approved materials.
  • Verify and route submissions appropriately; provide guidance on submissions as needed prior to MLR approval.
  • Develop and maintain strong working relationships with internal and external stakeholders.
  • Provide onboarding and refresher training to internal and external stakeholders on MLR process and works actively with MLR Manager to improve and update training.
  • Schedule MLR meetings; create and disseminate agenda and serve as the facilitator for MLR meetings, ensuring that all outcomes are accurately recorded.
  • Help to coordinate the submissions of materials to the FDA Office of Prescription Drug Promotion (“OPDP”) as required.

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:

  • Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated.
  • 3-5 years of relevant work experience preferably in science, medicine, pharma or promotional review
  • Strong understanding of industry practice, scientific principles and regulatory/quality systems in the drug development process.
  • Demonstrated project management skills, attention to detail and ability to meet timelines.
  • Demonstrated problem-solving skills with ability to generate proposed alternative solutions to Manager.
  • Ability to communicate effectively in team and cross-functional setting.
  • Excellent oral and written communication skills.
  • Demonstrated negotiation and interpersonal skills.
  • Ability to work in a team environment but can function equally well independently.
  • Familiarity with Veeva PromoMats.
  • Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, 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.