西安招聘

工作职责:

Major Accountabilities(Describe the 5-7 main results of the role to be achieved)

HGRAC Team Management

？ Hire, train, and supervise HGRAC team and allocate tasks to appropriate HGRAC specialist.

？ HGRAC specialist workload evaluation and calculation

？ HGRAC specialist’s on-boarding and hand-over process set up, including but not limited to hiring, training, hand-over report etc.

？ Leads, inspires and develops staff to improve and maintain their individual performance

？ Provides training and coaching to HGRAC specialists with regard to HGRAC policies and process.

？ Supervise and make proper QC for HGRAC specialists’ work.

？ Set up HGRAC work objectives and KPIs, and make them fully awareness for the objectives and KPIs.

？ Regular work review with individual HGRAC specialists to catch up and monitor work’s progression.

？ Yearly performance review and evaluate and feedback to HGRAC specialist.

HGRAC Process set up and Execution

？ Set up HGRAC process and validate the feasibility and update accordingly.

？ Work with key stakeholders to set up submission strategy, including but not limited to communication channel built up with HGRAC officers, and site GCP engagement strategy set up, enhance global awareness of HGRAC requirement and submission strategy (optimized/old process) set up.

？ Lead and oversight the whole process from documents collection, submission, tracking and archiving

？ Supports submission documents package preparation according to GCP/SOP/WP.

？ Set up lesson & learn database as a tool to do quality check and insights sharing with team.

？ Do quality check for the submission dossier according to HGRAC policies and lesson & learn database.

？ Oversight vendor’s performance for HGRAC outsourced service.

Job Profile – Trial Monitoring – HGRAC (Sr.) manager 08.04.2019

Training

？ Work with training team to develop training plans and coordinate training as needed, eg; on-boarding training, policy training and process introduction.

Key Performance Indicators(Indicate how performance for this role will be measured)

Ensure submission document package readiness within due date

？ Improve the pass rate

？ Ensure correct documents and wording in the application form are utilized.

？ Ensure the documents uploaded into HGRAC website strictly following the requirements of SOP/polies

？ Ensure HGRAC submission and approval in a timely manner.

？ Complete training within due date

？ Ensure no non-compliance of Novartis policy and SOP reported.

？ Ensure team members achieve their target as per KPI

？ Ensure team’s behaviour adherence to Novartis SOP and GCP requirement

任职资格:

Ideal Background (State the preferred education and experience level)

Education:

Degree in scientific or healthcare is preferred, or equivalent working experience

Languages:

Fluent English (Oral and spoken), Fluent in local language

Experience/Professional requirement:

？ minimum 5 years pharmaceutical industry experience with 4+ years strong experience in clinical research/HGRAC related work

Competencies:

Skills & Knowledge

？ Proven ability to manage teams and complex communication locally and in the global organization.

？ Able to work in a matrix organization

？ Ability to work under pressure

？ Strong Interpersonal skills

？ Strong leadership skills

？ Working experience in a global team, team player

？ Displays innovative ideas and solutions

？ Highly proficient in negotiation skills

？ Highly effective in influencing others

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