TITLE: Head of Medical Affairs, AustralAsia Who we are: Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Position Summary: The Head of Medical Affairs, AustralAsia (AuA) leads the Medical Affairs function by developing and executing medical affairs strategy and programs that support the AuA business. The Head of Medical Affairs, AuA, works with external and internal stakeholders to ensure delivery of key objectives and to fulfil the legal statutory duties of a Medical Affairs Lead in territories within Australasia (Australia, New Zealand, Malaysia, Taiwan, Hong Kong and any other countries as required). The position reports to the VP of Medical Affairs (Most of World) with a dotted reporting line to the Head of AustralAsia and is a member of the AustralAsia Leadership Team. The position has 3 direct reports and is based in Macquarie Park, Sydney. The Head of Medical Affairs, AuA will work closely with Indivior staff, in collaboration with the Medical Affairs team to train and educate the field teams of each territory within the Australian market, as well as to ensure compliance with required regulatory processes such as the TGA, Medicines Australia code of conduct, copy clearance, certification of sales representatives, study management, responding to medical information queries and pharmacovigilance. The Head of Medical Affairs, AuA, ensures that the following activities are performed effectively for the AuA region: Provide medical education and support services to external addiction healthcare providers including education meetings, workshops and conduct advisory boards when needed. Generate new data from non-interventional phase IV and RWE studies and support investigator-initiated studies aligned with the Global and AuA strategies. Build and support a network of influential relationships in the treatment community to provide a supportive environment for expanding patient access within a framework of evidence based best practice. Furthermore, the key responsibilities of the position include: Develop and execute the Medical Affairs strategy and plan in line with the organisations strategy. Provide regional input to ensure high professional and ethical standards in terms of various regulatory activities, clinical trials support, marketing support, and medical affairs including pharmacovigilance and information in accordance with standards of Good Pharmaceutical Medical Practice in certain markets. Lead the Medical Affairs function in AustralAsia markets either through a third party or Indivior infrastructure, ensuring that the business is compliant with local statutes and specifically that it meets any requirements stipulated by national regulatory authorities; and medical information services. Ensure compliance with MAH commitments and assist with the development and registration of NPDs or licensing agreements. Develop and provide the company, its customers, and the government, medical and technical information related to Indivior’s products. Provide, review and ensure medical activities (including promotional support, operational review and planning and clinical protocols) are implemented in alignment with product strategies, and in compliance with regulatory policies and guidelines. Coordinate activities surrounding issues with various governmental, regulatory, trade and professional agencies as and when they may arise such that a focused effort is put into issues to gain competitive advantage and where appropriate, raise the profile of Indivior products. This involves direct liaison with national regulatory/governmental bodies and academic or clinical opinion leader groups as required and to assist with medical and technical support as required. Develop strong relationships with key opinion leaders (KOLs) in therapeutic, regulatory, political, trade and professional arenas. This is especially the case in the addiction business which involves new and evolving regulation, laws, directives and guidelines in various markets. Work closely with external partners. Ensure suitable systems are in place to maintain the safety of patients. Help to distinguish Indivior as the leading addictions company and increase acceptance of the treatment of opioid dependence, it is essential that Indivior develops effective relationship networks and programs for consensus, education, intervention and dissemination of best practices. Working in conjunction with professional associations, KOLs and the Indivior cross functional teams to develop consensus on and deliver educational programs and training to external healthcare professionals and payor organisations and internal Indivior staff in the therapeutic area of opioid dependence and the use of our products specifically in order to help to improve patient outcomes and ensure proper medical practice. Support the generation of new data through a program of IITs, phase IV non-interventional studies and RWE to support best practice and the goals of the company. Work with internal and external teams, support compliance of the Company in terms of medical training, copy clearance, study management, projects and MI processes. Day to day oversight of country operations for the Australian business where responsible person status is registered with regulatory authorities and ensure that country operations are compliant with medical responsibilities. Effectively coach, develop and manage direct reports within the AuA Medical Affairs team. Grow and develop therapy area knowledge on treatment based upon evidence based best practice in healthcare providers, payors and patients. Identify a network, cultivate and maintain professional relationships with key medical, payor and government KOLs and guideline groups to strengthen the adoption and best practice use of Indivior brands. Partner with internal Health Policy team, Regulatory Affairs and Commercial teams to achieve key strategic objectives in the business (policy changes favourable to the delivery of quality treatment and expanded patient access, best practice clinical guidelines, regulatory changes, studies and projects such as epidemiological surveys, investigator initiated studies, publication plans, health economic initiatives, pricing and reimbursement, audit). Create and maintain relevant departmental SOPs in alignment with business requirements. Provide medical leadership with internal and external audits. Work closely with Integrity and Compliance Officer in monitoring medical activities and ensuring the AuA business is compliant. Any other duties as assigned. Who you are: You are a self-motivated, driven individual who loves the challenge of engaging with and influencing a diverse range of stakeholders. More specifically the successful candidate will possess the following qualifications and experience: Bachelor’s degree in Life Sciences (MBBS preferred) Postgraduate qualifications (such as Medical Doctor or Pharmacist) Broad medical and pharmaceutical industry knowledge and experience 10 years of experience in medical affairs within the Pharmaceutical industry Experience in managing teams and coaching and developing people Experience in effectively working in a cross functional environment Broad knowledge of regulatory frameworks Knowledge and experience in the application of the Medicines Australia Code of Conduct and Code of Practice – Medicines New Zealand Experience of working with and influencing decision makers Broad experience in copy approval and all aspects of legislation and relevant codes of practice regulating the promotion of medicines An understanding of pharmacovigilance activities and willingness to develop a level of knowledge to fulfil the local PV requirements Valid Australian Driver’s License In addition to the minimum qualifications, our new team member will also be able to demonstrate: Proactive, self-motivated approach with high level of initiative, persistence and resilience A clear and logical thinker with the ability to recognise patterns and develop innovative solutions with a pragmatic/commercial style to problem-solving Strong customer focus with the ability to communicate with many and varying stakeholders, including senior leaders Ability to develop and communicate argumentation in order to influence externally and internally Flexibility of thinking in order to facilitate working with many different professional disciplines Strong sense of urgency and achievement Expert organisational skills with the ability to manage multiple tasks and priorities under deadline constraints Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. In addition to a competitive base salary, bonus and car allowance, the Indivior experience includes: Additional paid leave days for Volunteering and Diversity and Inclusion 14% employer superannuation contribution $4000 p.a. Health Insurance Allowance Paid Parental leave Great office facilities with parking Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees Indivior is an Equal Opportunity Employer