Summary of Relevant Job Responsibilities

• Contribute to Quality and Risk Management Framework / Program across C&R.
• Drive continuous improvement for Clinical Trials Quality.
• Manage/support GCP inspections relating to clinical research activities.
• Support management in the resolution of quality related issues.

Major Responsibilities Duties

• Risk assessment and quality oversight plan
  • Collaborates with the line functions within C&R, to perform risk assessments and identify key data/procedures and high risk areas.
  • Proactively analyses quality data and leverages quality indicators to identify potential trends and risks.
  • In alignment with risk assessments, contributes to the QA strategy and quality oversight plan.
  • Supports the identification of audit substrate for scheduling as appropriate.
• Audit
  • Prepares, conducts QA audits, generates audit reports on time, communicates results to relevant stakeholders (e.g. Vendors/Clinical Operations).
  • Interacts with various teams to ensure proper root cause analysis is performed and corrective and preventative actions are developed and approved.
  • Tracks corrective and preventative actions and bring QA observations to closure as applicable.
• GCP quality expert
  • Serves as member of project team through participation in the applicable meetings, providing GCP compliance advice and guidance, to achieve continuous quality improvement in HMP.
  • Support Significant Quality Issues management, including perform root cause analyses, review remediation (corrective and preventative actions).
  • Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation.
• Inspection management
  • Provide inspection readiness and management support as appropriate.
  • Develops and delivers awareness training internally and externally.
  • Develops and shares lessons leant after inspection with relevant stakeholders.
• QA optimization
  • Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure continues improvement.
  • Promotes standardization of auditing approach within QA.
  • Routinely suggests new audit techniques/aids in areas of technical expertise.
  • Provides training and mentorship to less experienced members of QA staff.
  • Contributes to build the work climate/culture within QA function, exemplifies the leadership behaviors.

Position Qualifications & Requirements

• Minimum bachelor’s degree in clinical medicine or Life/Biological Sciences, advanced degree preferred.
• Experience in clinical research (min. 5 years) & quality management/ quality control (min. 3 years).
• Experience in risk assessment and mitigation planning.
• Good at English writing and speaking.

If interested, please forward your resume to KellyL@hutch-med.com

Primary

Act as principal link between the investigator and HMP for trial management, esp. on-site monitoring
 

Responsibilities

• Be familiar with trial execution process of assigned trial
• Be responsible for following activities:
  • Site selection
  • Prepare Site specific documents include but not limit to EC presentation slide, GCP office require documents, Inform Consent, study contract, site drug management manual, subject management matrix etc.
  • Site initiation
  • Site monitoring based on applicable monitoring plan
  • Site close out visit
  • Key personnel to coordinate with trial specific vendors to complete the trial related activities.
  • Complete all trial related reports within SOP defined timeline
• Site level trial master file and investigator site file management
• Deliver trial related training to site staffs
• Update site status to project manager at timely manner
• Prepare all required reports to line manager in a timely manner

Qualifications

• At least 1 year clinical trial on site management experience
• At least bachelor degree in Clinical Medicine or Pharmacy or related major
• Good communication skill and team player
• Good command of computer skill
• Adequate verbal and written communication skills in English
• Down-to-earth and hardworking spirit
• Willingness to travel (up to 75%) of working time

 
If interested, please forward your resume to KellyL@hutch-med.com

Apply Now

Primary Function

• Management of clinical research project.
• Vendor (CRO, Lab, drug storage, etc.) supervision and management.
• Liaison with KOLs.
• Support IND and NDA filing.
• Quality control of the clinical research projects, such as co-monitoring.

Responsibilities

• Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
• Provide leadership in the conduct of clinical trials, protocol implementation, data analysis, management of project progress and timelines.
• Input operational part of the protocol for trials.
• Review and approve study CRFs.
• Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
• Contact with CMC department regarding design of labeling, packaging and drug logistics.
• Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
• Select clinical trial site and keep good relationship with investigators.
• Initiate and ensure timely submission to IRB/IEC and support investigator as necessary.
• Support contract negotiation with study sites.
• Select and cooperate with statistician to conduct data analysis when required.
• Participate in regular Data Quality Review Meetings.
• Coordinate final trial report.
• Support CRO Selection.
• CRO supervision at the trial level.
• Support IND and NDA filing: Document review and progress tracking.
• Do co-monitoring visits for the project.
• Review monitoring reports.
• Check TMF before archiving.

Qualifications

• At least bachelor degree in pharmacy, biochemistry or related major. Mater degree is preferred.
• At least 3 years industry experience with proven proficiency in clinical research management for drug development.
• Good understanding of ICH guidelines, GCP and regulatory requirements.
• Excellent planning, organization and problem solving abilities.
• Good communication and interpersonal skills.
• Proficiency in English and familiarity with standard IT office tools.

 
If interested, please forward your resume to KellyL@hutch-med.com

Position Overview & Key Results Areas

The Medical Science Liaison serves as an advocate for company science within the healthcare community.  By virtue of his/her training, the MSL is well-positioned to discuss and provide scientific and therapeutic information to Health Care Professionals and Researchers (Clinical and Scientific Leaders) viewed by their peers to be authorities in a therapeutic field.  The MSL is responsible for ensuring that he/she is fully versed in the therapeutic area and up-to-date on all major studies, both ongoing and completed, competitive product information and clinical data.
 

Responsibilities

Develop an understanding of regional and national scientific leaders and the healthcare environments in which they work through effective professional engagement with scientific leaders that are centered on science and credible exchange of unbiased scientific information.

• Interact with managed care organizations, healthcare professionals, clinical investigators, and other healthcare organizations providing fair, balanced, and scientifically rigorous medical and clinical information.
• Meet with healthcare professionals who might be interested in engaging in a scientific discussion regarding a product’s medical and clinical profile in the context of approved prescribing information as well as in response to unsolicited questions or requests for information which may involve off-label information. (Unsolicited means that the information request was neither suggested nor encouraged  by the MSL or sales representatives)
• Participate in the development and implement tactics identified in the Medical Affairs Plans (MAP).
• Work with clinical research personnel to identify potential investigators clinical research projects, based on the investigator's expertise and access to appropriate patients.
• Alert investigators to company program for Investigator Initiated Study Proposals, working together with the medical manager on the process for submitting investigator designed proposals for review and approval; encourage and facilitate research publication of investigator initiated studies, in strict compliance with company policy and local country regulations.
• When requested (and consistent with local SOPs), may represent the Medical Department at Local or Regional Medical events (e.g. Medical Congresses and Symposia.)
• Facilitate the submission and publication of the study result from investigator initiated or company initiated projects.

Qualifications

• Candidates to possess a master degree in the life sciences (MD, Pharm.D, or Pharmacist, Biology) preferably with a specialization in the experience of Oncology.
• Requires strong scientific baseline knowledge in therapeutic area, clinical trials methods, implementation and interpretation, sound scientific and clinical judgment, and eagerness to learn more in depth in therapeutic area.
• Strong, confident and engaging presentation skill, and capable for customer facing.
• Outstanding communication and skills and the ability to function within a team environment.
• Proactive

If interested, please forward your resume to winniew@hutch-med.com

Apply Now

Major Responsibilities and Duties

• Review product registration dossier and relevant documents
• Obtain IND & NDA approval as well as product registration license renewal as planed
• Coordinate with each function within HMPL from registration pathway
• Establish and maintain relationship with external stakeholders
• Liaise with external stakeholders for regulatory needs of HMPL
• Implement regulatory activities as required by governmental regulations and internal SOPs
• Form accelerate Strategy for product registration

Qualifications:

• Bachelor degree and above in Pharmacy or Pharmaceutical
• 7 years or more drug registration experience in pharmaceutical industry
• Prefer oncology drug registration background
• Good understanding of Chinese pharmaceutical & regulatory environment
• Good relation with stakeholders related to product registration
• Fluent English
• Strong communication skill
• Passion in drug development

Internal-External Relations

• Internal: RA team, CR team, Research dept., CMC Dept., GA Dept., etc.
• External: NMPA, CDE, NIFDC, CFDI, CHP, etc.

If interested, please forward your resume to KellyL@hutch-med.com