Legal & Compliance Officer ANZ
About The Position
Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across the world, helping to save and improve the lives of patients suffering from the most challenging diseases.
Medison ANZ has deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored-solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and to expand their reach to patients in ANZ.
Medison ANZ is rapidly growing and is backed by Medison Pharma’s 25 years of established operations, global infrastructure, and partnership network. Medison is headquartered in Israel, with commercial hubs in Europe, Americas, New Zealand, and Australia.
Compliance: Reporting to Compliance Director, the Officer will be responsible for all the compliance matters in his/her designated Cluster. He/she will be enhancing the global and regional compliance standards and supporting the continued development and implementation of Medison’s compliance program and ethical behavior.
The Officer will be responsible for ensuring that Medison and its partners accede to regulatory requirements, both national and international, as required by local regulation and law. He/she will ensure full adherence to standards, policies, and procedures. He/she will also be responsible for enhancing internal policies, ensuring that the organization holds internal audits to prevent lack of control and corresponding regulation. Some international travel will be required.
Legal: The Officer role is of critical importance in assisting Medison to strengthen and expand its commercial and operational infrastructure in the ANZ region, seeking to accelerate access to therapies for rare and life threating diseases.
The Officer brings a broad-based knowledge of laws and regulations governing the biopharmaceutical companies, including privacy laws, particularly in the area of rare diseases and highly innovative therapies, gained in either biopharmaceutical company(ies) or in a leading life science law firm.
Responsibilities
- Ensure adherence with global standards and local laws and regulations.
- Provide local compliance clearance/approval and review.
- Ensure local third-party vendors pre-approvals.
- Lead local compliance committees.
- Responsible for local compliance training in line with global program.
- Advise local management on compliance related matters.
- Provide compliance support to local business initiatives.
- Share local feedback and updates to relevant global compliance functions.
- Participate/lead global compliance initiatives as needed.
- Provide strategic direction and compliance leadership to the cluster.
- Actively participate and serve on regional leadership teams, providing compliance guidance consistent with the Company’s culture and values to promote ethical behavior, and enhance the Medison global compliance program.
- Lead proactive compliance initiatives such as risk assessments, compliance workshops, training initiatives, and other compliance monitoring activities.
- Develop, implement, and manage compliance programs, processes, and systems to mitigate compliance risks.
- Identify opportunities for growth and enhancement of the Medison global compliance program partners with regional colleagues and countries leadership teams under your scope to maintain and further develop throughout the organization a strong culture of compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving.
- Draft and/or update appropriate policies to ensure compliance with applicable laws, regulations and industry codes and alignment with global policies.
- Support the implementation and maintenance of affiliates transparency reporting requirements and assist business leadership in meeting reporting obligations.
- Assist in implementation and execution of regional and local risk based third party due diligence
- Support investigations into allegations of misconduct, as required.
- Manage administrative and operational aspects of the Compliance program in the countries under your scope.
- Provides high quality advice and timely guidance in all areas of the affiliates business including corporate, supply chain, market access, commercial, medical affairs, antitrust matters, general compliance and data privacy issues;
- Advises on various product launches and in-market execution on all fronts, partnering with local affiliates and cross functionally, ensuring alignment with local, regional and partners` strategies and goals;
- Advises on all aspects related to interaction and engagements with healthcare professionals, healthcare organizations and patient organization.
- Drafts, reviews, negotiates and supports implementation of a wide range of agreements in all areas of operations.
- Advises on various other general business-related matters and works cross functionally to secure strategic and timely legal advice, enabling Medison to develop and optimize its business in a fully compliant and efficient manner.
- Plays a key role in identifying and executing legal priorities, actively leading or contributing to cross regional legal projects (e.g. create working methodology and procedures, elevate knowledge of applicable laws and regulations within the organization, optimize governance)
Requirements
- Law degree from a recognized university and qualification to practice law in one of the preferred locations published for this role
- Minimum of 5 years’ experience in the pharmaceutical sector acquired either at a law firm or in-house at a pharmaceutical / biotech company, with a minimum of three years’ experience in a compliance function.
- Possess an exceptional knowledge of pharmaceutical industry laws, guidelines, and codes.
- Strong communication and presentation skills as well as a focus on detail are also essential
- Experience working with other APAC countries
- Successful track record of building a culture of compliance and ethics
- Fluent English – written and verbal is a prerequisite
- Strategic understanding and outlook
- P&L management knowledge and experience together with excellent grasp of economics
- Ability to influence across senior stakeholders internally and externally
- Open to give & receive feedback
- Interested to continuous learning
- Self-management & proactive
- High ethical and compliance standards
- Excellent interpersonal & presentation skills
- Ability to lead and implement change
- Able to encourage and lead cooperation between functions
- Commercial, financial and marketing acumen and skills
- Managing complexity (across brands, markets, functions)
- Building, engaging and leading high-performance teams