Career Category

Medical Affairs

Job Description

Employment Type

• 1Y Contract, can be extended

Role Description

• Report to PMS manager

• Local Medical role
• Support the PMS study execution

Role and Responsibilities

• Provides guidance on the implementation and conduct of PMS studies in accordance with local PMS regulation by supplying appropriate advice and consultation to the Clinical Study Team (CST) as below:

• Provide guidance for Ethics/IRB documents and translations to country representatives to support submissions and responses to Ethics questions
• Review and ensure proper content of all PMS reports (exemption, periodic and re-examination)
• Manage the timeline, quality control process, publishing and required approvals of all PMS reports (exemption, periodic and re-examination).
• Ensure PMS report submissions to the MFDS are completed within specified timelines and with adherence to Amgen SOP’s
• Provide input on PMS study design and protocol development ensuring local regulatory requirements are considered
• Provide guidance on the per patient cost and site budget according to local PMS regulation
• Provide expertise to the CST to help identify risks/issues related to PMS studies and advise on the best way to address these risks/issues
• Provide advice on country level documents to supplement core regulatory packages for local health authority (HA) submissions and responses to regulatory questions

• Support the communication for PMS with MFDS
• Support the CST to drive effective decision making by providing knowledge of PMS regulations and MFDS requirements
• Support the management of vendors (CRO) to the required standards for both in-house and outsourced studies, as applicable.
• Provide local insights/expertise regarding decisions to proceed to Site Evaluation Visits (SEV’s) for potential sites in collaboration with the local medical team and global study operations-site management (GSO-SM).
• Attend CST and designated sub-team meetings as appropriate

Key Activities

• Provide guidance to the study team on planning and management of PMC execution in accordance with the local regulation.
• Contribute to study level goal setting.
• Provide feedback on the protocol during the study design process to ensure the PMC reporting requirements are met
• Provide input on the identification, selection, set-up, and management of vendors
• Contribute to the execution of the feasibility process in collaboration with the CST
• Support local study team (LST) to provide guidance on site evaluation and site selection plans
• Review and provide input to develop study specific documentation (e.g. study specific training documents, Ethics/IRB documents)
• Provide guidance on the best strategy for recruitment plans and support the implementation of these plans
• Provide best practices for site engagement in PMC studies to support timely data entry and query resolution
• Ensure CST is aware of reporting requirements for all PMC reports 
• Review data tables and provide feedback to ensure all reporting requirements are considered
• Review PMC reports and provide feedback for required content, acceptable format and completeness
• Review translated PMC reports for accuracy and acceptable verbiage
• Support internal audit and inspection activities and contribute to CAPAs
• Support regulatory agency inspection readiness activities

Basic Qualifications

• Bachelor’s degree & 1~3 years of directly related experience or equivalent

Knowledge

• Advanced knowledge of global clinical trial management
• Clinical trial processes and operations
• Knowledge of local PMC regulations and guidelines
• Project and Program management including oversight of study deliverable, budgets and timelines

Key Competence

• Project Management
• Relationship Management and influencing skills
• Oral and written communication
• Time management
• Business English
• Ability to work effectively in a team/matrix environment on multiple projects

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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