Job Description

Turn evidence into impact. Shape how science is delivered.

AbbVie is seeking a Senior Medical Operations Associate for a 12 month Max Term Contract to join our Medical Affairs team in our brand new Sydney CBD offices. This is an opportunity to step beyond traditional study operations and take a leading role in how scientific evidence is generated, managed and communicated across Australia and New Zealand.

You’ll combine evidence generation, study project management and scientific publications within a highly team-oriented Medical Affairs environment. You’ll take ownership of multi-country observational studies, work across local and global teams to keep complex studies moving, and act as a key point of expertise for affiliate publication activities.

From study start-up, ethics submissions and site agreements through to data management, publication planning and process improvement, you’ll have visibility across the full evidence lifecycle and the opportunity to influence how we deliver high-quality scientific evidence across ANZ.

KEY DUTIES AND RESPONSIBILITIES

- Serves as the SME for executing and managing multi-country observational studies (MCOS) in line with local regulations and SOPs, and guides study teams on compliance with these requirements.
- Ensure audit/inspection readiness.
- Assume project management responsibilities for selected key affiliate-led studies to ensure on-time delivery.
- As required, provides input into Medical Affairs evidence generation planning cycle for the affiliate under the direction of the Evidence Solutions Manager.
- As relevant, provides guidance and mentorship to associates involved in evidence generation activities.




- Assists the Evidence Solutions Manager with local dashboards and metrics that demonstrate the value and impact of local evidence generation.
- As an affiliate Study Project Manager for MCOS, is responsible for study start up and maintenance related activities to ensure successful, on time, and quality execution of deliverables for assigned studies and sites. Responsibilities include but not limited to:
- Establish plans with Medical TA Lead for on time study execution including risk assessment and mitigation.
- Internal and external stakeholder management including proactively identify and communicate issues impacting delivery and providing proposed solutions.
- Responsible for ethics and other required local submissions including customization of ICFs.
- Prepares and negotiates site budgets and contracts.
- Delivers initial overview and training on the electronic data capture (EDC) systems at site training visits.
- Co-ordinates / issues site green light letter
- Facilitates global data management (DM) activities by reviewing/running/triaging DM reports, and working with the in-field team and global study team to ensure on time query resolution.
- Assists in-field team and escalates study related issues at sites to the global team as necessary.




- Leads regular evidence generation meetings with the Medical Affairs team to stay updated and promptly identify and address issues to ensure projects are completed to planned timelines.

- For all Medical led evidence generation activities, assists in managing and processing study payments and maintaining essential documents for Medical managed studies.
- Assists with other evidence generation activities (e.g. IIS, collaborative studies, registry support) as required.
- Is the affiliate SME for the execution and management of scientific publications per AbbVie policies and SOPs.
- Co-ordinates and oversees all affiliate scientific publication activities. Responsibilities include but not limited to:

- Drives affiliate completion of publications planning process by Publication leads
- Completing Submitter activities in the AbbVie publications system (CLEAR)
- Conducting QC check of compliance documents
- Works with/guides Publication Leads to ensure timely execution to publication plans
- Communicates any updates and process changes to Publication leads

- Provides strategic input on study selection and execution, reviews new functional systems, processes and procedures, and provides feedback for process improvements and process standardisation.
- Support the generation of monthly dashboards and metrics.
- Adherence to all other relevant external and company policies, procedures and regulations
- 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 codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
- Other ad hoc duties such as administrative duties, as requested.

📌 Senior Medical Operations Associate (Sydney)
🏢 Abbvie
📍 Sydney