We Are Hiring

Apricus is a pharmaceutical company located in the greater San Diego, California area that offers outstanding opportunities in pharmaceutical development.

Apricus Biosciences, Inc. employs a best-in-class group of professionals with the skills and expertise to operate our business successfully. We recognize that a pleasant and productive work environment is an important aspect of our culture and we celebrate individual and company-wide performance.

Apricus Biosciences, Inc. is an equal employment opportunity (EEO) employer, and makes employment decisions on the basis of merit. We vigorously oppose discrimination of any kind. Company policy prohibits unlawful discrimination based on: race, color, creed, gender, religion, sex, national origin, ancestry, pregnancy, age, marital status, registered domestic partner status, sexual orientation, medical condition including genetic characteristics, physical or mental disability, veteran status, or any other consideration made unlawful by federal, state or local laws. This policy also prohibits discrimination based on a perception that anyone has any of those characteristics, or is associated with a person who has or is perceived of having any of those characteristics. All such discrimination is unlawful. This policy applies to all personnel practices, including but not limited to: recruitment, hiring, training, promotion, compensation, benefits, and transfers.

Apricus Biosciences, Inc. complies with all the applicable provisions of the Americans with Disabilities Act (ADA) and does not discriminate against applicants or employees because of physical or mental disability. The company will make reasonable accommodations to the extent required by law when requested by employees or applicants with disabilities provided the individual is otherwise qualified to safely perform the essential duties and assignments connected with the job and provided that any accommodation does not impose an undue hardship on the Company.

Benefits

Apricus Biosciences, Inc. is committed to providing competitive and high quality benefits for its employees. Regular full-time employees are eligible to receive a benefits package, including medical, dental, vision, long term disability and life insurance along with those mandated by state and federal law. Additionally, employees receive vacation, sick and personal days, as well as Company assigned paid holidays. Employees are also eligible to participate in the Company’s 401(k) retirement program.

 

Regulatory Affairs Associate

Company Overview

Apricus Biosciences, Inc. is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

For further information on Apricus Bio, visit www.apricusbio.com.

For consideration, please e-mail resume and salary requirements to hr@apricusbio.com. Please include the position title in the subject of your e-mail.

Position Overview

Manages clinical project team members to appropriate and timely completion of projects; oversees project timelines, development and maintenance.

  • Reports to: Associate Director, Regulatory Affairs
  • Department: Regulatory
  • FLSA: Exempt
  • Location: San Diego, CA

Duties and Responsibilities:

Core responsibilities include, but not limited to the following:

  •  Coordinate regulatory submissions relevant to assigned projects, in accordance with submission and approval requirements, including in functional groups across the organization in the development of relevant data to complete regulatory submissions

      • Assist with preparation and maintenance of Clinical Trial Application dossiers, e.g. Investigational New Drug (IND) and Investigational Medicinal Product Dossiers (IMPDs)
      • Assist with preparation and maintenance of product authorization applications
      • Assist with responses to objections/questions issued by Regulatory Authorities/Agencies
      • Support the preparation, review and approval of compliant regulatory documents
      • Work effectively with colleagues to continuously improve regulatory and compliance systems, teamwork and efficiency
    • Evaluate proposed nonclinical, clinical and manufacturing changes for regulatory filing strategies
    • Ability to follow technical discussions, identify regulatory data needs and to evaluate regulatory issues
    • Perform initial (or preliminary) review of labeling, batch records, test results to ensure compliance to approved specifications and  to cGMP and other applicable regulations
    • Provide input and assist in the review and approval of documentation for operations at contract vendors
    • Assist in audits, either internal or at contract organizations
    • Assist in operation and maintenance of document control function

    Complete other duties, tasks and projects as required

     Requirements

    • Bachelor’s degree in a related field required
    • Understanding and application of principles, concepts, practices and standards, and knowledge of industry practices
    • Understanding of GxPs (GCPs, GLPs, GMPs) and FDA and ICH guidelines
    • Three years or more related experience (e.g. regulatory, quality, clinical research experience)

     Working Conditions:

    Domestic and International travel may be required (about 10%).  May, on a continuous basis, sit at desk for a long period of time. Intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 30 lbs. may be required.  The noise level in the work environment is usually low to moderate.  Must be flexible to work varying schedules and hours as needed. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Clinical Program Manager

Company Overview

Apricus Biosciences, Inc. is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

For further information on Apricus Bio, visit www.apricusbio.com.

For consideration, please e-mail resume and salary requirements to hr@apricusbio.com. Please include the position title in the subject of your e-mail.

Position Overview

Manages clinical project team members to appropriate and timely completion of projects; oversees project timelines, development and maintenance.

  • Reports to CMO
  • Department: Clinical
  • FLSA: Exempt
  • Location: San Diego, CA

Core responsibilities include, but not limited to the following:

  • Serve as primary representative to the assigned research program(s), facilitate mutually beneficial relationships with internal/external partners, including members of the program team, internal cross-functional teams, pharmaceutical study sponsors, and key external opinion leaders and investigators.
  • Oversee clinical trial development in the assigned research program(s) from trial concept design through acceptance of concept for protocol development. Provide program leader(s) support to ensure time effective delivery of concept development and in the maintenance of study review/ approval documentation as appropriate.
  • Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate.
  • Collaborate with cross-functional teams in order to develop and maintain the clinical trial pipeline strategy to ensure continued program success.
  • Create, maintain and distribute pipeline and other related reports and identify gaps in program menu on a routine basis. Provide routine reporting of the program status to management.
  • Maintain appropriate documentation and tracking of various program needs.
  • Develop concept related status reports, such as Gantt charting to communicate with cross-functional teams, institutional partners, etc. as needed on behalf of the program leader(s).
  • Manages data release and review meetings for projects; reviews and participates in finalizing and approving final manuscript or final reports for projects.

 Qualifications:

  • Three-plus years of experience in clinical/regulatory affairs, five-plus in the pharmaceutical industry in technical departments such as operations, quality assurance or various development functions.
  • A minimum of a B.S. degree in the sciences (e.g. Microbiology, Biology, or Chemistry) or engineering.
  • Thorough knowledge of FDA regulatory requirements.  Worldwide regulatory knowledge a plus.
  • Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies.
  • Preparation of clinical documentation in support of regulatory submissions.
  • Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals.
  • Independently motivated.
  • Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
  • Excellent oral and written skills (proficient in Microsoft Office, Power Point and Project)
  • RAC Certification a plus
  • Research Professional Certification (CCRP) or exam eligibility preferred.

 Working Conditions:

Domestic and International travel is required (about 30%).  May, on a continuous basis, sit at desk for a long period of time. Intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 30 lbs. may be required.  The noise level in the work environment is usually low to moderate.  Must be flexible to work varying schedules and hours as needed. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.