Medical Review Specialist

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

At AbbVie, we believe better health outcomes start with trusted information.

We're looking for a Medical Review Specialist to join our Medical Affairs team in Sydney for a 12 month Max Term Contract, 3 days per week, and play a pivotal role in ensuring the scientific accuracy, integrity and compliance of materials across our diverse therapeutic portfolio. This is a unique opportunity for a healthcare, scientific, medical affairs or regulatory professional who enjoys partnering with stakeholders, navigating complex decisions and influencing outcomes through expertise rather than authority.

You'll work at the intersection of Medical Affairs, Regulatory Affairs and Commercial, helping teams bring high-quality, compliant communications to healthcare professionals and patients across Australia and New Zealand.

KEY DUTIES AND RESPONSIBILITIES

• Provide expert advice, guidance and training on the relevant processes, Code and regulatory requirements relating to review of promotional & non-promotional materials and activities for the assigned therapeutic portfolio.
• Conduct efficient and high-quality medical and regulatory review of materials according to internal SOPs and external laws, regulations, and Codes.
• Partner strategically with both Commercial and Medical teams, to support consistency with the necessary compliance standards, while aligning with the broader business and therapeutic strategy.
• Collaborate closely with internal stakeholders, fostering a partnership approach, and offering expert advice and recommendations to optimise content and ensure that medical accuracy and regulatory compliance aspects are embedded in materials.
• Support the team in driving a consistent approach to medical and industry code review across the business. Includes attendance of regular group meetings initiated by the Head of Medical Affairs Communications.
• Develop and maintain Code and review-process related internal resources, including SOPs and guidance documents to facilitate compliance and clarity for stakeholders
• Provide specialised medical/scientific information support to the commercial teams in defence of the brands, including response to Code complaints and initiation of complaints.
• Support Commercial as well as Learning & Development teams with medical/scientific training associated with products within the assigned therapeutic portfolio in collaboration with Medical colleagues and Product Managers.
• Participate in cross-functional approaches to projects and product issues within assigned therapeutic portfolio.
• Coordinate label update impact assessments to support the material owners and brands in the relevant updates to product-related materials.
• Maintain up-to-date knowledge of developments in relevant regulatory and Code requirements, as well as the clinical/scientific body of evidence within assigned therapeutic portfolio.
• Provide second-line support if required, in the provision of specialised medical/scientific information to healthcare professionals and consumers.
• Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
• Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie’s internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Pharmacy, Life Sciences, or Biomedical degree (e.g. Pharmacology major)
• Medicines Australia Code of Conduct CEP Accreditation – Program 1 (or in progress)
• Minimum 1 year in pharmaceutical, healthcare, or medical communications environment
• Understanding of and experience in pharmaceutical/regulatory Code-compliant review processes and promotional material standards
• Materials and activities and ability to apply them to real-world materials and communication channels.
• Critical and thorough appraisal of the scientific literature, including study design, endpoints, and limitations. Competence in interpreting statistical results, forest plots, integrated safety data, and exposure-adjusted event rates.
• Strategic mindset with a focus on compliant solutions.
• Strong decision-making and prioritisation skills.
• Ability to search scientific information within the literature.
• Ability to navigate and adapt to ambiguity and risk.
• Demonstrated ability for both problem solving and consolidation of medical facts and clinical data.
• Effective communication skills considering appropriate context, timing and method. Ability to effectively communicate medical and scientific information to audiences with varying medical/scientific understanding.
• Strong negotiation and diplomacy skills – able to uphold compliance while maintaining constructive relationships
• Attention to detail with a commitment to continuous learning and adaptability
• Familiarity with using Veeva PromoMats/Medical

Flexibility and Availability: In line with Australia’s 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

Additional Information

AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing CareersANZ@abbvie.com or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

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.
   

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.

• AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
• All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.
• Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
• AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html