Senior Medical Review Specialist

4 weeks ago

Mascot, Australia AbbVie Full time
Job Description

The Opportunity

Your primary focus will be in the development and review of promotional and non-promotional materials and activities in Australia and New Zealand. You will ensure that all materials align with the highest standards of medical and scientific integrity while adhering to the necessary legal and regulatory frameworks.

You will bring your deep understanding of medical and scientific aspects, as well as extensive knowledge of relevant Industry Codes of Conduct/Practice, laws, regulations, and AbbVie policies.

Working closely with the Therapy Area Specialist Manager, you will contribute to driving a consistent approach to medical and Code review across the entire organization. By championing this approach, you will ensure that our materials and activities meet the required standards and reflect our commitment to excellence.

Major Responsibilities:

  • Provide deep expert guidance and advice to internal stakeholders on the relevant Industry Codes of Conduct/Practice (“Code”), laws and regulations and AbbVie policies, relating to review of promotional & non-promotional materials (“Materials”) and activities.
  • Provide specialised medical and scientific guidance and advice to internal stakeholders on medical aspects relating to Materials and activities for assigned therapeutic portfolio.
  • In collaboration with the Commercial and Medical colleagues, support the development of compliant Australian and New Zealand promotional & non-promotional materials ensuring they support quality use of medicine principles.
  • Conduct efficient and high-quality medical and Code reviews of Materials for use in Australia and New Zealand, according to the Code, external laws, regulations, and internal SOPs.
  • Support the Therapy Area Specialist Manager in driving a consistent approach to medical and Code review across the business.
  • Provide specialised Code support to the commercial and medical teams in defence of brands, including response to Code complaints and initiation of complaints.
  • Provide training and guidance on industry/association guidelines and Code to Medical and Commercial teams.
  • Support Commercial Teams and Customer Excellence Training Supervisors, with medical/scientific training associated with products within the assigned therapeutic portfolio in collaboration with Medical colleagues and Product Managers.
  • Lead and/or support internal cross-functional projects within assigned therapeutic portfolio and the broader Medical department that lead to business and/or process improvements. Map processes, conduct gap analyses and consistently review performance to maximise KPIs within the medical department.
  • Participate in local and regional/global as well as external industry task groups where relevant.
  • As a senior member, mentor and coach members within the Therapy Area Specialist team. Lead training and upskilling initiatives for Therapy Area Specialist members in areas of need.
  • Maintain up-to-date knowledge of codes and regulations, as well as developments and published literature within the assigned therapeutic portfolio.
  • Provide medical information expertise in the construction and review of local standard responses to a broad range of medical information enquiries when required.
  • Maintain adherence to company and regulatory requirements.

Qualifications

Education/Experience Required:

  • Pharmacy or Life Sciences (e.g. Pharmacology major) Degree
  • Experience within the pharmaceutical industry within the area of Medical Information/Medical Affairs or Regulatory Affairs. Should include extensive experience in the review of promotional and non-promotional material.
  • Medicines Australia Code of Conduct Continuing Education Program (CEP) Accreditation – Program 1.

Essential Skills & Abilities:

  • Expert knowledge and understanding of the relevant Industry Codes of Conduct relating to review of promotional materials and activities.
  • Critical and thorough appraisal of scientific literature, including ability to search and find relevant scientific data.
  • Demonstrated ability for both problem solving and consolidation of medical facts and clinical data.
  • Ability to effectively communicate medical and scientific information to audiences with varying medical/scientific understanding.
  • Project management and ability to lead an internal project team.
  • Coaching skills.


Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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