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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Material Review Specialist

Primary Sydney, Australia Req ID 2212491 Category Medical Division AbbVie

JOB SUMMARY:

Conduct high-quality review of all promotional and non-promotional materials and activities according to internal SOPs, relevant Industry Codes of Conduct and external laws and regulations, with a particular focus on digital, multichannel, and on-demand related activities and materials. The incumbent will also provide training and advice to internal customers on medical review processes, codes of practice and regulations.

JOBS SUPERVISED

N/A

KEY DUTIES & RESPONSIBILITIES 

Responsibilities 

  • Support the development and review of promotional and non-promotional material in collaboration with the Commercial teams and Medical colleagues in accordance with all relevant regulations, industry voluntary codes of practice, and internalpolicies and procedures.
  • • Support the optimisation of approval pathways for on-demand digital content. Collaborate closely with multichannel experts within Customer Excellence function.
  • • Support the generation and presentation of metrics reports across all company medical review activities.
  • • Ensure that materials have been discussed conceptually between therapy area assigned Medical personnel and the material initiators, prior to entering the materials review system.
  • • Ensure adherence of all activities to company and regulatory requirements as well as industry voluntary codes of practice.
  • • Provide training and guidance on industry/association guidelines and codes of practice to Medical and Commercial teams.
  • • Support Commercial Teams by developing and leading training in collaboration with Medical colleagues and Learning.
  • • Participate in and drive cross-functional approach to projects, process and product issues for digital, multichannel, and on-demand related activities and materials.

JOB REQUIREMENTS

Education and Experience

  •  Pharmacy or Life Sciences (i.e. Pharmacology major) Degree
  • Experience within the pharmaceutical industry within the area of Medical Information/Medical Affairs, including experience in the review of promotional/non-promotional material and product training would be advantageous.

PROFESSIONAL SKILLS

Regulatory Processes - Applies knowledge of processes involved in submitting documents to regulatory bodies

Regulatory Expertise - Understands, applies, and complies with internal and external regulatory standards. Uses appropriate ethical, legal, and regulatory standards

Drive Execution - Focuses on results and motivates self and others to execute against commitments on time

Stakeholder Alignment - Serves as a common thread between diverse stakeholders to ensure alignment

Business Partnership - Champions business partnerships through mutual respect to achieve common goals; aligns to final decisions even if not in agreement

THE ALLERGAN COMMITMENT

Doing What is Right- Never jeopardize patient safety, product quality or complaince; always act with integrity

WAYS WE WORK

All For One AbbVie;We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.

Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn’t work and get on to what does.

Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.

Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.

Make Possibilities Real; We question with endless curiosity. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.

KEY INTERFACES

Associate Director, Medical Affairs

ANZ Medical Affairs Team

Regulatory Affairs Team

Sales Team

Marketing Team

Legal

Compliance

Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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