Senior Medical Affairs Operations Associate-1400007608W
Description
- Sydney based – North Ryde
- Coordinate and track Risk Management Plans & Periodic Safety Update Report submissions, implement and monitor safety initiatives and lead SOP reviews and other compliance activities.
Be Vital in this role…
Reporting to the Medical Affairs Operations Associate Director, this position will focus on the overall coordination and timely submission and tracking of Risk Management Plans (RMP) and Periodic Safety Update Reports (PSURs) to TGA and Medsafe; have overall responsibility for the internal implementation and monitoring of RMP activities; and lead Standard Operating Procedure (SOP) impact assessments, training and other compliance activities.
Key responsibilities & competencies include:
- RMP & ASA Development & Submission – Primary responsibility for the overall coordination of the timely development, review, approval and submission to TGA and/or Medsafe of the Australian Specific Annex (ASA) and RMP, through close liaison with all relevant stakeholders.
- RMP & ASA Implementation, Tracking & Reporting – Primary responsibility for the implementation and determination of effectiveness of all agreed activities in the ASA/RMP through liaison with relevant stakeholders.
- PSURs – Primary responsibility for the overall coordination of receipt, submission and tracking of PSURs for all Janssen products requiring PSUR submission to TGA and /or Medsafe.
- Training – Provision of training to medical and customer-facing personnel on the requirements of safety-related activities agreed to with TGA and /or Medsafe.
- Impact Assessments of Cross-Pharma Documents – Provide Impact Assessments on local SOPs of documents issued from global/regional colleagues.
- Standard Operating Procedures – Lead the preparation of new and review of existing Company SOPs to ensure local compliance to global, regional and local regulatory requirements.
- Metrics – Assist with the implementation of KPIs and measures and the regular collection of data for the preparation of reports as agreed with Manager.
Key working relationships include:
- External –health care professionals, TGA, Medsafe
- Internal –local, regional, and global Drug Safety personnel & all personnel involved with development/implementation/tracking/reporting of ASA/RMP and PSUR activities
Qualifications
Be valued for who you are…
Key to success in this position will be your proven ability to demonstrate the following in a complex environment:
- A degree in pharmacy or life science
- Experience in Medical Affairs, including Drug Safety and/or Regulatory Affairs
- Pharmaceutical industry experience in clinical trials will be highly regarded
- A track record of success with excellent communication skills managing stakeholder interactions
- A collaborative, results-orientated style and approach
- High integrity and work ethics, in line with our company's core values
Be part of something bigger than yourself…
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
Please submit a résumé & cover letter in application.
Alternatively, for confidential discussion please contact Virginia Tam in the Johnson & Johnson Talent Acquisition team on 02 9815 3804.
Agencies please note: this recruitment assignment is being managed directly by Johnson & Johnson’s Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.
Primary Location:Asia Pacific-Australia-New South Wales
Organization: Janssen-Cilag Pty Ltd (7490)
Job Function: Technical Assurance
Description
- Sydney based – North Ryde
- Coordinate and track Risk Management Plans & Periodic Safety Update Report submissions, implement and monitor safety initiatives and lead SOP reviews and other compliance activities.
Be Vital in this role…
Reporting to the Medical Affairs Operations Associate Director, this position will focus on the overall coordination and timely submission and tracking of Risk Management Plans (RMP) and Periodic Safety Update Reports (PSURs) to TGA and Medsafe; have overall responsibility for the internal implementation and monitoring of RMP activities; and lead Standard Operating Procedure (SOP) impact assessments, training and other compliance activities.
Key responsibilities & competencies include:
- RMP & ASA Development & Submission – Primary responsibility for the overall coordination of the timely development, review, approval and submission to TGA and/or Medsafe of the Australian Specific Annex (ASA) and RMP, through close liaison with all relevant stakeholders.
- RMP & ASA Implementation, Tracking & Reporting – Primary responsibility for the implementation and determination of effectiveness of all agreed activities in the ASA/RMP through liaison with relevant stakeholders.
- PSURs – Primary responsibility for the overall coordination of receipt, submission and tracking of PSURs for all Janssen products requiring PSUR submission to TGA and /or Medsafe.
- Training – Provision of training to medical and customer-facing personnel on the requirements of safety-related activities agreed to with TGA and /or Medsafe.
- Impact Assessments of Cross-Pharma Documents – Provide Impact Assessments on local SOPs of documents issued from global/regional colleagues.
- Standard Operating Procedures – Lead the preparation of new and review of existing Company SOPs to ensure local compliance to global, regional and local regulatory requirements.
- Metrics – Assist with the implementation of KPIs and measures and the regular collection of data for the preparation of reports as agreed with Manager.
Key working relationships include:
- External –health care professionals, TGA, Medsafe
- Internal –local, regional, and global Drug Safety personnel & all personnel involved with development/implementation/tracking/reporting of ASA/RMP and PSUR activities
Qualifications
Be valued for who you are…
Key to success in this position will be your proven ability to demonstrate the following in a complex environment:
- A degree in pharmacy or life science
- Experience in Medical Affairs, including Drug Safety and/or Regulatory Affairs
- Pharmaceutical industry experience in clinical trials will be highly regarded
- A track record of success with excellent communication skills managing stakeholder interactions
- A collaborative, results-orientated style and approach
- High integrity and work ethics, in line with our company's core values
Be part of something bigger than yourself…
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.
Please submit a résumé & cover letter in application.
Alternatively, for confidential discussion please contact Virginia Tam in the Johnson & Johnson Talent Acquisition team on 02 9815 3804.
Agencies please note: this recruitment assignment is being managed directly by Johnson & Johnson’s Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.
Primary Location:Asia Pacific-Australia-New South Wales
Organization: Janssen-Cilag Pty Ltd (7490)
Job Function: Technical Assurance