Therapy Area Specialist
Therapy Area Specialist
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Job Description
The Therapy Area Specialist (TAS) plays a critical role in supporting compliance with local industry Codes of Conduct/Practice (Code) and internal policies through the rigorous review of promotional and nonpromotional materials from both medical and regulatory perspectives within the assigned therapy areas.
Acting as a strategic partner you will provide expert advice guidance and recommendations to both commercial and medical teams in the development review and approval of materials for Australia and New Zealand. In addition to supporting Code challenges and offering local Coderelated insights you will foster strong partnerships with key stakeholders to drive process improvements enhance collaboration and ensure alignment with AbbVies commitment to ethical and compliant communications that empower stakeholders and positively impact patient lives.
KEY DUTIES AND RESPONSIBILITIES
- Provide expert advice guidance and training on the relevant processes Code and regulatory requirements relating to review of promotional & nonpromotional materials and activities for the assigned therapeutic portfolio.
- Conduct efficient and highquality 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 Therapy Area Specialist Manager in driving a consistent approach to medical and industry code review across the business. Includes attendance of regular TAS group meetings initiated by the Therapy Area Specialist Manager or the Head of Medical Affairs Communications.
- 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 crossfunctional 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 productrelated materials.
- Maintain uptodate knowledge of developments in relevant regulatory and Code requirements as well as the clinical/scientific body of evidence within assigned therapeutic portfolio.
- Provide secondline 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 AbbVies policies and procedures.
- Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVies internal codes of conduct and compliance processes.
- Other ad hoc duties such as administrative duties as requested.
Qualifications :
- Minimum 1 year in the pharmaceutical industry within a medical function or similar function.
- Experience in reviewing promotional and nonpromotional materials.
- Pharmacy or Life Sciences Degree (e.g. Pharmacology major)
- Medicines Australia Code of Conduct Continuing Education Program (CEP) Accreditation Program 1
- Knowledge and understanding of the relevant Industry Codes of Conduct relating to review of promotional materials and activities.
- Critical and thorough appraisal of the scientific literature.
- Ability to search scientific information within the literature.
- 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.
- Effective communication skills considering appropriate context timing and method.
- Strategic mindset with a focus on solutions.
- Ability to navigate and adapt to ambiguity and risk.
Flexibility and Availability: In line with Australias 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 :
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 doesnt 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. Were never satisfied with good enoughpatients 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 Companys 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 serving our community and embracing diversity and inclusion. It is AbbVies 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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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
