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Legal and Compliance Lead - HP ANZ

The Position

Legal:

Provide prompt, commercial, practical legal advice to address the needs of the local organisation whilst ensuring compliance with applicable laws and regulations.
Draft, review and/or negotiate contractual agreements as needed. Frequent agreements include Clinical Trial Research Agreements, Sponsorship Agreements, Grants, Consultancy Agreements, Services Agreements.
Independently review, interpret, evaluate, and analyse current and emerging laws and regulations. Develop, present, and implement appropriate strategies to respond to external risks.
Support departmental and cross-functional projects, which may include leadership of special projects.
Collaborate, inform and agree with the Head of Legal & Compliance ANZ to ensure issues affecting the local organisation are shared and managed seamlessly.

Compliance:

Provide advice to the local organisation on Compliance-related topics
Set, implement and promote standards, processes and tools, teaching and training on compliance as well as fostering quality & compliance culture in the organization.
Perform and regularly update Compliance Risk Assessments in order to create and maintain a comprehensive compliance risk register and manage identified risks appropriately.
Monitor business practices and processes to ensure practices comply with internal Boehringer Ingelheim policies and procedures, as well as external laws and regulations.
Conduct end-to-end compliance incident handling covering reporting/capture of concerns, case investigation, incident substantiation.
Regularly report to the Compliance Committee on the status of Compliance Programs and current/evolving compliance requirements.
Obtain guidance and strategic initiatives from the regional Compliance Officer based in Singapore. Work closely and collaborate regionally with other Compliance Officers located throughout Asia Pacific.

Other:

Ensure that all applicable internal SOPs and external standards/requirements are being met
Undertake any other duties or tasks as the Head of Legal & Compliance ANZ may reasonably direct from time to time. This includes, without limitation, providing Legal and Compliance support to other functions as required, such as Animal Health and/or Group Functions.

Take reasonable care of the health and safety of yourself and others.
Cooperate with Boehringer Ingelheim management in the provision of a healthy and safe workplace.
Identify and correct unsafe conditions or behaviours and immediately notify your Manager of any accidents, incidents or near misses; complete the Safety Incident Reporting (RAINE) portalx within the required time frame in accordance with the Boehringer Ingelheim reporting procedures.
Undertake duties in accordance with the current Boehringer Ingelheim Policies and Procedures.
Report non-conformance in accordance with the requirements of the Boehringer Ingelheim quality systems.

Bachelor of laws degree or J.D. or equivalent degree.
Practicing certificate authorising legal practice in Australia.
Up to 5 years post-qualification experience in a Legal and/or Compliance role, preferably with prior experience at an in-house Legal or Compliance role in the healthcare sector.
Experience with pharmaceutical industry codes such as Medicines Australia Code of Conduct is preferred.
Business partner-oriented mindset and ability to connect to all layers and functions within the organization.
Ability to work independently and to prioritize and effectively manage multiple tasks at the same time while making decisions in a timely manner.

Group Functions

NSW

Boehringer Ingelheim

Full-time

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