- Safety vendor qualification assurance activities: project level QC, case QC, Key Performance Indicator (KPI) check; Safety management plan (SMP) review; Safety Contract/Agreement review;
- Ensure Hua PV’s compliance to meet regulatory/EC requirement via best vendor management;
- Regularly review SMP, PV agreement/contract;
- Any safety issue communication between vendor and Hua;
- Ensure vendor transfer all Hua safety documentation back to Hua after study close;
- Provide Medical review for each ICSR on behalf of Hua;
- Involve in safety documents draft, e.g. TPP, CDS, IB, IND annual report, etc;
- Involve in periodic safety data review for ongoing studies or from all other sources;
- Co-ordinate the Safety Management Team meeting as co-ordinator;
- Provides expert safety input to the clinical development program for assigned
projects/products, e.g. protocol review, CSR review;
- Provide safety related training to internal/external partners;
- Involve in Hua safety related SOP creation/review;
- Hua clinical drug safety function documentation maintain
- Bachelor Degree in medical, medicine or equivalent science;
- At least 3 years of safety working experience;
- Familiar with Word, Excel, Powerpoint, PDF use;
- Familiar with domestic and international Pharmacovigilance regulation/guideline;
- Experience with case processing, evaluation, QC, vendor management;
- Experience in cross-function teamwork;
- Fluent in spoken and written English and Chinese;
- Able to work independently, effectively, punctually;
• To provide actionable information that enhances the value and appropriate use of products to internal stakeholders; respond to customer inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of products and services and deliver appropriate clinical and scientific information that clinically differentiates products.
• To explore and analyze medical insight of the KOLs thus help central medical affairs team and marketing team formulate actionable medical and marketing plan.
• Plan and set up scientific exchange meeting to communicate with KOLs
• Be responsible for KOL mapping and engagement. Develop Hua advocators through scientific knowledge exchange and variety of medical activities.
• Follow up expert sponsored studies in field and be the field medical partner with KOLs.
Medical planning and business governance
• Responsible for field medical communication plan and provide medical input during local business plan development.
• Support regional speaker training collaborating with local marketing and sales teams.
• Provide disease and product knowledge training to sales team.
• Master degree in clinical medicine is a must and Doctor’s degree is preferred.
• 2-3 year of MSL experience in pharmaceutical industry. Or at least 2-years experiences as a clinician in hospital.
• Demonstrated expertise in discussing scientific content and context to multiple audiences
• Good oral and written communication and interpersonal skills
• Ability to travel (30-50%)
- Responsible for the clinical study protocol and clinical study report writing in the start- up phase and close-out phase;
- As the project management monitor to oversee relevant medical documents preparation;
- Closely work with the cross-functional team to collect and generate the various resources before writing or editing the report;
- Working closely with medical & clinical team to handle the relevant study based on the usage of capacity;
- At least master degree, preferred in clinical, medicine or biotech related area;
- Preferred with physician, research or scientist background, better with 1 year plus experience in the medical writing field;
- Preferred with the TA experience in diabetes or internal medicine;
- Fast learning ability;
- Good at written, reading and listening ability about English, business verbal English level is required as necessary;
Medical planning and business governance
• Take a leadership role in clarifying unmet medical needs and defining the patient Journey and then develop medical strategic plan.
• Be a medical expert to input medical strategies during the development of the business plan.
• By offering scientific and creative Input, contribute to the development, review, and approval of promotional materials for the brand team.
• Provide scientific training to sales, marketing and other functions.
Data generation and publication:
• Provide data generation strategic plan aligned with business strategy to address science issue thus to prolong life cycle of products.
• Responsible for phase 4 study design, and relevant document. Take leadership role and collaborate with clinical study operation team in the implementation of clinical trials.
• Responsible for investigator identification and selection and medical response.
• Collaborate with key experts to develop expert sponsored research.
• Develop publication plan based on clinical study plan. Perform data analysis and prepare publications (abstracts, posters, manuscripts).
Scientific Data Dissemination/Exchange
• Understand and actively address the unsolicited scientific information needs of external health care professionals
• Plan and set up advisory board meetings, and/or the facilitation of other meetings with health care professionals.
• Prepare or review scientific information in response to customer questions or media requests.
• Participate in data analysis and the development of publications (abstracts, posters, manuscripts).
• Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community
• Medical Doctor or master of Endocrinology & Metabolism.
• 2-5 years of Clinical practice. Pharmaceutical medical function experience is preferred.
• Demonstrated ability to balance scientific priorities with business priorities·
• Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Fluent in English, verbal and written communication.
- Lead and participate in Clinical Quality activities at local HUA MEDICINE offices for Clinical Research as well as other audit types within the clinical (GCP) audit program such as study specific audit, investigator site audit, process/system audit, Supplier/vendor audits, and regulatory inspections to ensure that HUA MEDICINE Clinical Research are meeting its regulatory requirements related to GCP;
- Involved in risk based planning for the clinical audit program;
- Involved in the training and mentoring of the clinical audit staff;
- Responsible for the provision of consultation and advice with respect to clinical quality to the CRDS. Pharmacology and Safety, and other relevant internal business partners;
- Bachelor degree in medical/biomedical discipline or equivalent;
- At least 8-10 years compliance experience (or equivalent) preferably with a pharmaceutical company, CRO, or similar organization;
- Experience conducting investigational site audits either independently or as part of a team;
- Experience conducting team audits of database, clinical study report, and/or process/system/facility audits;
- Experience conducting vendor audits either independently or as part of a team/or experience hosting sponsor audits;
- Knowledge/understanding of the approach and perspectives of regulatory agencies;
KEY DUTIES AND RESPONSIBILITIES:
1. Prepare, review and negotiate legal documents, e.g. contracts, agreements, MOU, statement, POA etc.. Review and approve contracts on the internal contract approval system.
2. Provide legal advice to internal clients according to applicable laws and regulations, including: pre-clinical trial, clinical trial, insurance, promotion, interactions with health care professionals, competition law, anti-bribery, local employment laws etc..
3. Assist with the evaluation of the organization’s current and proposed business practices, policies and transactions to identify key legal and compliance issues for China. Draft or update procedures/ guidelines / SOPs to ensure the company comply with all relevant laws and regulations, internal policies and industry codes.
4. Assist with corporate governance matters.
5. Liasion with outside legal counsel as needed.
6. Deliver legal trainings to staff at various levels and 3rd parties, e.g. vendors, distributors and suppliers etc.
QUALIFICATIONS (KNOWLEDGE, EXPERIENCE, ABILITIES & SKILLS)
• 3-5 year working experience in either multinational company or reputable law firm;
• Experience in pharma industry is preferred;
• Proficiency in both spoken and written English；
• University degree or above with a major in law from top law schools; oversea legal education is a plus;
• PRC bar qualification；
• High integrity, accountable, business acumen, good communicator, efficient, team player and ability to work independently under pressure.
1. 针对每一项早期临床研究制定和撰写QC计划，进行on-site QC，确保临床研究过程符合公司批准的研究方案、公司SOP、GCP及行业标准，并完成QC报告。
5. 根据需要，对NDA 资料包中的部分文件进行定稿前QC，协助确保NDA递交资料的质量。
6. 根据需要，制定GCP QC的SOP计划，并负责相关SOP的起草工作。
2. 有5年以上CRA或QC相关工作经验，有直接参与国家现场核查经验；有global study经验更佳。
3. 对ICH-GCP 和临床试验的相关法规非常熟悉。
• Responsible for design and implementation of early development studies from first in man throughout proof-of-concept by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in PoC studies.
• Accountable for clinical development strategy with corresponding molecule(s) in Diabetes area.
• Acts as medical monitor for both domestic and international clinical studies.
• Participate and support strategic planning and implementation among Diabetes area.
• Interact with external experts from healthcare organization and/or institutions in Diabetes area.
• Key Opinion Leader management.
• Evaluate clinical centers and foster communication with crucial collaborating investigators.
• Participates in analysis of studies and presents results to relevant decision boards.
• Lead publication and external presentation of PoC clinical study results.
• Holding CRO/Partners accountable for the high quality standards of their deliverables.
• Accountable for compound related Biomarker strategies; works closely with Biomarker Expert in implementation.
• Prepare and implements disease area or project-specific training and educational programs for project team colleagues from pharmacology and other line functions. Mentor pharmacology colleagues on scientific, clinical, and drug development issues.
• Medical doctor;
• Minimum 5 years of clinical development experience (at least as clinical research physician for 3 years) in pharmaceutical and/or biotech industry;
• Experience with scientific expert interactions;
• Fluency in English, both oral and written communications;
• Familiarity with concepts of clinical research and clinical trial design;
• Knowledge of Good Clinical Practices (GCP), FDA, EMEA/CHMP and CFDA regulations and guidelines, and applicable international regulatory requirements;
• Sufficient knowledge of relevant disease area;
• Build and lead DMPK team to support preclinical and clinical projects in BA, PK and PB/PK/PD modeling.
• Serve as DMPK expert in the integrated research and early development project team (DDI, mass balance, BA/BE, TQT, organ dysfunction, et al.); lead the study design and coordinates PK/modeling related elements for projects.
• Contribute expert PK/modeling inputs into key pre-clinical, clinical and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager.
• Lead the publication of scientific papers for the early development studies.
• Oversees PK, PB/PK, PK/PD, DMPK biopharmaceutical and M&S performed with a variety of tools and approaches. Review and ensure analysis plan and report timeline and quality.
• Maintains good collaborative relationships with CRO/Partners and ensure high quality standards of their deliverables.
• Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance).
• Attends meetings with external parties including investigators, outside experts, and health authorities.
• PhD in Pharmacokinetics, Drug Metabolism, Pharmacometrics or related field.
• A minimum of 8+ years of industrial experience in clinical PK/PD of small molecule drug R&D.
• Expert knowledge of preclinical and clinical PK, PBPK M&S, PopPK and PK/PD analysis.
• Good understanding and knowledge on drug research and development.
• Good people management skill and experience.
• Good understanding and knowledge on LC-MS/MS bioanalysis.
• Good verbal and written communication skills in both Chinese and English.
Daily tasks relating to corporate finance, corporate development, and investor relations functions
• Financial modeling and analysis
• Presentation material preparation
• Coordination with various vendors and investors
• Perform market research, data mining, business intelligence, and valuation comps
• Minimum 1 year of working experience in investment banking
• Familiarity with Microsoft office functions - Word, Powerpoint, Excel
• Proficiency with financial modeling
• Bachelor’s degree required
• Native fluency in spoken and written Mandarin Chinese and fluency in spoken and written English
• Attention to detail
• Ability to multi-task and work independently
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