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Associate Director, Promotional Materials & Compliance

7+ years
Not Disclosed
10 Oct. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Your Job:
We are excited to announce a new opportunity for an experienced Regulatory Professional to join our Clinical Services team as the Associate Director of Promotional Materials & Compliance (PMC). In this role, you will lead the delivery of PMC services to our clients, ensuring alignment between local and global offerings in collaboration with your global peers. Your responsibilities will include:

  • Review and Oversight: Act as the medical and regulatory reviewer and/or signatory for promotional materials, ensuring compliance with regulations.
  • Training Development: Develop and deliver local training on codes of conduct for clients.
  • Audits and SOPs: Participate in audits, CAPA recommendations, and the development and review of Standard Operating Procedures (SOPs).
  • Business Development: Engage in local business development activities to enhance PMC service offerings.
  • Team Leadership: As the service grows, you will have the opportunity to build and lead a PMC team in Australia.

Your Profile:

  • Qualifications: Formal qualifications in Pharmacy or Science.
  • Experience: Minimum of 10 years in the Pharmaceutical or Biotechnology industry, with at least 8 years in Regulatory Affairs focused on advertising and promotional review of marketed prescription drugs.
  • Regulatory Knowledge: In-depth understanding of Australian and New Zealand regulations for drug promotion/advertising and experience interacting with the TGA and Medsafe.
  • Skills: Self-motivated, natural problem-solver, critical thinker, commercially minded, with exceptional communication and stakeholder management skills.
  • Leadership: Proven experience leading a high-performing team and managing multiple projects effectively.

We Offer:
By joining PharmaLex, you will be part of a team renowned for its expertise in the field. We foster a culture where everyone feels valued and heard, encouraging the development of new skills and capabilities for career growth. This full-time role is based in St Leonard’s, Sydney, NSW, with flexible working options, including varying start and finish times and hybrid work arrangements.

If you are interested in this challenging opportunity with PharmaLex, we look forward to receiving your application, including your earliest possible starting date, any visa requirements, and salary expectations online.