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

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Responsibilities

• Be responsible for CRA team management and operational management system.
• Oversees the performance of the CRAs within their specified team. Implements professional development and performance evaluations;
• Ensures that clinical monitoring activities of their assigned team are performed to the project’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;
• Supports the training and development of clinical monitoring personnel within their remit and ensures team members’ consistent use of study tools and training materials;
• Tracks clinical monitoring metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings;
• Performs on-site Accompanied Site Visits with CRAs;
• Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;
• Serves as a point of contact for CRAs and other team members for assigned projects or initiatives;
• Assists with assessing and interviewing potential clinical monitoring candidates;
• May conduct on-site monitoring visits to offer support to project teams;
• May perform site visit report review and track site visit report metrics to ensure compliance;
• May review and provide feedback on related SOPs and TOOLs during updates;
• Serves as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.

Education 

• Sc. in a field relevant to clinical research

Experience

• Minimum of 10 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry

Knowledge and skills

• Excellent oral and written English skills.
• Excellent line management skills
• Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
• Quick learner, good adaptability and versatile;
• Excellent leadership, judgement and problem-solving skills;
• Strong organizational, communication, time management and multi-tasking skills.

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

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Responsibilities

• Support medical director in drafting clinical trial protocol and study report.
• Contribute to  the  medical/scientific  input  given  for  the  development  of  trial-related documents such as IB, ICF etc. and processes which reside in other line functions.
• Establish and maintain liaisons with investigators.
• Serve as back-up medical monitor to provide medical support to trial sites and clinical operation team.
• Support regulatory filing where medical expertise is required.
• Support drug discovery when clinical experience is needed for the medical “translation”.
• Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.
• Prepare and conduct regular meetings with investigators.
• Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.
• Support the  regional clinical  strategy for  a  project  through  Clinical  development, in partnership with relevant matrix team members.
• Compliance with GCP, SOP and regulatory requirements.
• Study planning, preparation, conduct and report in terms of timeline, quality and quantity
• Other tasks as assigned.

Requirements

• Graduate from Clinical Medicine with bachelor degree or above.
• At least 3-5 year clinical practice / clinical development / clinical research experience. Therapeutic area experience esp. oncology or hematology. Working experience with international pharmaceutical company or CRO is preferable.
• GCP experience is preferred.
• Proficiency in English and good computer skill at office software.
• Excellent planning, organization and problem solving abilities.
• Good communication and interpersonal skills.
• Good project management skill.
• Self-motivation and good risk management.

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

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Primary Function

The Senior statistician is responsible for all statistical aspects of a clinical development project of one compound, from early clinical development, to registration and marketed product support.
 

Responsibilities

• Serves as statistical representative in the cross-functional teams for the strategic planning, execution for product development and trial design.
• Involved in research activities for innovative statistical methods and applications in clinical trial development.
• Prepare statistical related sections in clinical trial protocols, clinical trial reports, submission documents, and publications.
• Develops statistical analysis plans (SAP) or oversees SAP development.
• Oversees trial conducts from statistical perspective.
• Assist with or be responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations.
• Oversees process and quality of statistical work contracted out to a CRO or research collaborator.
• Performing statistical programming to validate the results produced by CRO or to meet internal need of data analysis (e.g. for publication, or for optimizing assumptions for study design), when needed.
• Mentors junior colleagues in techniques, processes.

Qualifications

• PhD degree in statistics/biostatistics or related discipline with a minimum of 2 years work experience as statistician in pharma/CRO, or a Master’s degree with a minimum of 4 years work experience as statistician in pharma/CRO.
• Thorough knowledge of statistical methodology, pharmaceutical research and development strategies and execution, GCP and regulatory guidelines.
• Good project management skills
• Excellent communication and presentation skills to interact with authorities and external bodies (specialists as well as non-specialists) on statistical-methodological issues
• Strong time management and prioritization skills
• Knowledge of statistical tools such as SAS, nQuery, PASS, East
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.

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

Primary

The Drug Safety Specialist/Senior Drug Safety Specialist is responsible for the collection, processing, follow-up, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products in accordance with company standard operating procedures and applicable regulations.
 

Responsibilities

• Process individual case safety reports
• Perform proper coding in the safety database
• Produce concise and accurate case narratives
• Submit individual and periodical safety reports to the regulatory agencies
• Appropriately follow up AEs and SAEs
• Conduct AE/SAE reconciliation
• Perform literature searching and review
• Generate data listings from the safety database

Experience

• Required Skills and Knowledge:
  • Attention to details
  • Good knowledge of medical terminology
  • Good written and communication skill
  • Fluent in Chinese (spoken and written) and in English (written)
  • Computer literacy
• Desired Skills:
  • Experience in pharmaceutical safety-related role
  • Previous Argus database experience

Requirements

• EDUCATION: Life science/Pharmacy/Nurse degree
• CONTACTS: Regulatory Affairs, Medical Affairs, Clinical Project Manager and other Safety Staff

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

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Primary Functions

Responsible for executing end to end clinical database setup and management activities pertaining to clinical trials, including but not limited to: database setup and SAS programming development activities in compliance with Hutchmed Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of DBD work contracted to a CRO.
 

Major Responsibilities and Duties

• Provide database setup service and SAS programming development service for clinical trials;
• Contribute to the review, maintenance, and ongoing update database setup and SAS programming in accordance with the database User Acceptance Test (UAT);
• Develop the System Edit Check (EC) and SAS Edit Check (EC) in accordance with the Data Validation Plan (DVP);
• Maintain and update System EC in accordance with the EC UAT results;
• Assist in review of study-specific demands including aCRF, database specs, DVP, SAS listing, and customized report specifications;
• Perform database configuration, access management, and training for assigned trials;
• Contribute to the eCRF development, annotation, modification, and database maintenance activities;
• Assist in the development of database training for assigned trials;
• Participate in the development and implementation of database technology or tool;
• Understanding of ICH-GCP and CDISC principles;
• Perform other activities as required.

Qualifications

• Specialized Knowledge:
  • Clinical Data Management System experience (e.g., RAVE, Clinflash, Inform, OC RDC) and understanding of database/programming concepts.
  • Knowledge of the clinical development process.
  • Knowledge of industry standards and practices, e.g. CDISC.
• Minimum Requirements:
  • Educated to at least Bachelor level in IT, Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
  • At least 5-year DBD experience in pharmaceutical company or Clinical Research Organization (CRO)
• Preferred Requirements:
  • Familiarity with other clinical database tools like CTMS, IRT/RTSM, ePRO, IRC/MIRS，and PV/ Argus
  • Prior experience with SAS programming is preferred;
  • Strong programming skills in C++, Java, or Python is preferred;
  • Able to work under pressure and in a changing environment with flexibility;
  • Good communication skills with the ability to communicate with both the technical and business areas.

Internal-External Relations

• Internal:
  • Project team within HMP.
• External:
  • CRO/vendors, consulting experts, co-development/business partners as appropriate;
  • Must be prepared to describe and demonstrate the job attributes to regulatory authority inspectors during regulatory authority inspections.

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

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Primary

• Responsible for Chemical test in QC laboratory

Principle Roles & Responsibility

• Strictly follow the relevant standard operating procedures and testing method procedure of laboratory;
• Execute the release testing of raw materials, packaging material, intermediate products and finished products, and initiate the relevant testing reports.
• Execute the finished product stability testing, and initial the relevant stability reports.
• Initial and revise the chemical test methods and specifications for all materials (including raw materials, excipients and packaging material), intermediate products and finished products;
• Initial and revise the protocol of method transfer and validation for chemical testings;
• Execute method transfer and validation according to protocol, initial and review the validation report accordingly;
• Initial and revise the standard operating procedures for relevant equipment, instruments, reagents, test solution, reference standards and volumetric solutions;
• Initial and revise the validation protocol for laboratory chemical analysis instruments; cooperate in the qualification/validation, maintenance and calibration of instruments used for chemical testing.
• Responsible for the chemical testing for utility qualification, key production equipment qualification, product process validation and cleaning validation;
• Report the OOS results, and conduct laboratory investigation per line manager instruction;
• Provide specific information when communicating with government drug testing agencies;
• Responsible for the safety, health and environmental protection (EHS) of itself position;
• Complete other tasks assigned by line manager.

Qualification and Experience

• College degree or above in pharmacy relevant major;
• 2 years of relevant work experience;
• With good physical and chemical testing skills and knowledge;
• Familiar with chemical laboratory procedures， laboratory instrument operation and regulatory requirements;
• Experience with chemical method validation is preferred;
• Experience with USP and EP is preferred.

If interested, please forward your resume to Yuhuaw@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

Primary Functions

• The mission of Hutchison MediPharma (US) Inc. Regulatory Affairs is to develop innovative global registration strategies that advance our pipeline products through approval in US and EU
• In this position, the Regulatory Affairs Scientist-Strategy (Senior Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies
• Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU.

Major Responsibilities and Duties

• Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries;
• Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators;
• Liason with US FDA, EU and other regulatory authorities as assigned;
• Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU;
• Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development;
• Ensure compilation of electronic submissions according to current health authority standards;
• Provide regulatory oversight by developing and implementing SOP’s;
• Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects

Qualifications and Education Requirements

• BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR
• Advanced degree, e.g. PhD, PharmD and 2 years industry experience
• Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals
• NDA or BLA filing experience a plus
• Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines
• Good leadership, organization, problem-solving & communication skills
• Excellent written and oral communication skills
• Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process
• Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus
• Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus
• Knowledge of EU regulatory regulations a plus
• Ability to manage priorities and workflow, managing multiple projects and meeting deadlines
• Acute attention to detail
• Good judgement with the ability to make timely and sound decisions

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

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Primary Responsibilities

• Provide medical and safety expertise as the Product Safety and Pharmacovigilance representative on the product clinical development team.
• Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA).
• Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, safety management plans, study reports, summary of clinical safety and risk management plans.
• Manage and conduct ongoing safety surveillance on assigned products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary.
• Organize and conduct safety management team meetings for assigned products and be responsible for safety surveillance, signal detection and risk management.
• Coordinate the development of guidelines and ensures the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory safety reporting requirements. 

• Ensure that the safety profiles of assigned HMP products are accurately and consistently represented in relevant labeling documents and aggregate safety reports, identify and lead updates as required.

• Provide support for medical review of individual case safety reports (ICSRs) for assigned products.
• Collaborate with Chinese counterparts and other functional team members to update them on medical assessment, signal detection and safety risk management practices in the US and international markets
• Identify opportunities and manage continuous improvement initiatives related to safety assessment of pharmacovigilance data from all sources.
• Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk management.

QUALIFICATIONS

• Physician (MD or equivalent) with minimum 6 years related experience in clinical safety and pharmacovigilance.
• Experience in the oncology therapeutic area is preferred.
• Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs and global safety regulations are highly preferred.
• Experienced in global regulatory environment and processes, and the ability to integrate safety medical knowledge with regulatory and commercial input.
• Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance, benefit risk and potential strategic impact of the data and present the findings clearly in both written and oral communications.
• Experienced in PV documents (DSUR, PSUR, and PBRER etc.) and risk management plans.
• Thorough understanding of US and EU pharmacovigilance regulations, GCP and ICH guidelines.
• Demonstrated knowledge of biostatistics and epidemiology are preferred.
• Good ability to interpret complex clinical data and experimental results.
• Working knowledge of validated drug safety database (preferably ARGUS) and MedDRA.
• Ability to influence, negotiate and communicate with both internal and external stakeholders.
• Excellent English (writing and speaking) and excellent mastery of English medical terminology.

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Primary Function

The Statistical programmer/Senior Statistical Programmer is responsible for all statistical programming aspects at project level. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverable.

Responsibilities

• Lead statistical programming activities at project level.
• Co-ordinate activities of all programmers either internally or externally assigned to the study/studies. Make statistical programming recommendations at study level.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team.
• Review eCRF, discuss data structures and review activities as member of the Data Review Team.
• Comply with company, department and CDISC standards and processes, review and develop programming specifications as part of the analysis plans.
• Provide input into statistical programming solutions and/or ensure their efficient implementation.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverable as well as accuracy and reliability of statistical analysis results.
• Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and training.
• Develop company SAS macros and utilities.

Complexity

• Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology
• Knowledge of statistical methodology

Specialized Knowledge

• Extensive programming experience in SAS including Data step, Macros, Statistical procedures, and Output delivery system
• Good knowledge of CDISC standards including:
• Study Data Tabulation Model (SDTM)
• Analysis Data Model (ADaM)
• Clinical Data Acquisition Standards Harmonization (CDASH)

Requirements

• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related fields is required
• At least 2-3 years’ experience in pharmaceutical company or Clinical Research Organization (CRO) as statistical programmer
• Positive working attitude

Preferred Requirements

• Working experience in oncology projects
• Self-management skills with a focus on deliverables
• Project management experience

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Responsibilities

• 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
• 5 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

Apply Now