• Phone: +86 21 63862192
  • Mailbox: info@alphabiopharma.com.cn
  • Shanghai: Unit 05-08, 5F, Platinum Building, No.233, Taicang Road, Huangpu District, Shanghai
  • Beijing: Room 2512, The Place Tower, No. 9 Guanghua Road, Chaoyang District, Beijing

Talents Acquisition

Associate Manager, Legal

  • Location:Shanghai
  • Released Time:2020-11-24
  • Number of Hire:1
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Job description

Combined with the regulations and the company's rights and interests, review the legal documents including but not limited to contracts, work orders, confidentiality agreements, term sheets, etc., and provide solutions to the risks therein.
Draft the company's foreign-related legal documents, including but not limited to term sheet for BD, license in/out agreement, resolution documents of Shareholders' meeting / board of Directors.
According to the relevant directive of the company, collect and sort out the contract data of the company, establish the contract management database; issue the contract management report regularly, and point out the company's contract management risks and solutions.

Job requirements

Proficient in company law, contract law, securities law and other relevant laws, regulations and judicial interpretation, legal documents drafting.
Excellent in legal English (including wrting and reading).
Legal professional qualification certificate.
3 year's legal working experience including 1 years legal working experience in law firm/accounting firm/listed group company.
Quick thinking, strong logic, excellent expression and writing skills.
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Quality Assurance Director (Plant)

  • Location:Suzhou
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

Insure the GMP related operations during entire process that is iconform to relevant regulation and policy and timely updated accordingly.
Lead QA staff to fulfill all duties of QA department, such as quality system management, packaging material management, on-site control, validation and so on.
Complete the quality analysis report termly and report to VP, Manufacturing Operation.
Support on filing/data consolidation for IND/NDA process on new drugs
Establish and optimize quality management system in alignment of guidance on GMP.
Establish and effectively develop the Quality team as leader.
Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position.

Job requirements

Bachelor or above degree in medicine or a related field.
10 years or above working experience as a QA role in manufacturing sit of pharmaceutical industry.
Be expert in GMP requirement.
Independently thought with problem analysis and resolving skills.
The experience of plant setting up is preferred.
Good written and verbal communication skills both in Chinese and English.
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QC Manager (Plant)

  • Location:Suzhou
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

Provide technical support within Quality Control to project teams & manufacturing site.
Perform technical review with the analytical data package generated internally and externally to ensure compliance and data integrity, e.g. DS/DP release test, stability test, analytical method validation, reference material qualification/ requalification etc.
Monitor the main changes within quality system documents occurred at site, e.g. specification, test method, stability protocol etc.
Participate troubleshooting activities within quality investigations to ensure that all critical and major lab issues are thoroughly investigated with appropriate corrective actions.
Provide the required analytical information in regulation filling activities, as needed. Implement and enhance Good Documentation Practice principle.
Support qualification, calibration and maintenance of the analytical equipment, method validation, annual product reviews in Alpha Biopharma.
Support the implementation of practical training program.
Be responsible for planning and implementing technical transfer on QC perspective.
Establish and effectively develop the team as team leader.
Other duties as assigned by superior.

Job requirements

Bachelor or above degree in medical /a related field.
Minimum of 5 years of experience in QC Lab in pharmaceutical industry.
Mandate to have in-depth understanding of Data Integrity principle, the routine lab processes, ICH and pharmacopeia.
Capability of arranging and completing tasks per priority.
The experience of plant setting up is preferred.
Good written and verbal communication skills both in Chinese and English.
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PV Physician

  • Location:Shanghai
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

The role is responsible for the accuracy, integrity of safety data collected in clinical trials, ensuring the benefit-risk balance of company products.

Individual case safety report (ICSR) review:
1) Perform medical review of individual case safety report (ICSR) according to SOPs and liaising with other functions, as required
2) Writing Pharmacovigilance/MAH comment and assessing company causality
3) Assessing seriousness and expectedness of reported events
4) Providing medical advice to case processing team

Safety data review:
1) Perform safety data review for ongoing clinical trial from PV perspective

Risk management:
1) Identify, evaluate and confirm the safety risks in clinical trial
2) Generate dRMP and RMP
3) Communicate and execute the mitigation plan for risk minimization

Other assignment instructed by line manager

Job requirements

Bachelor of medicine (or above), Board certified or Board eligible or equivalent medical training is preferred. 3-5 years related working experience. More requirements are listed as below:

1) Familiar with PV e-system such as Argus
2) Excellent interpersonal, verbal and written communication skills
3) Good knowledge of medical terminology (both Chinese and English)
4) Ability to manage multiple and varied tasks and prioritize workload with attention to detail
5) Ability to assess the clinical relevance of medical data and to interpret its clinical meaning
6) Strong knowledge of international drug regulation including GCP, GVP
7) Relevant experience into pharmacovigilance/Drug Safety field is preferred
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RA Project Manager

  • Location:Beijing
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

Be responsible for all aspects of the new product development process from project initiation to product launch, to ensure timely delivery of projects within time, scope, cost and quality
To manage allocated formulation development projects for agreed targets:
Define the scope of work for each new project, identify tasks and responsibilities for assigned project team members, establish target completion dates for key project milestones using PM software
Maintain project management information system eg. SmartSheet etc. for tracking of project timelines, resources, man-hours and cost on a routine basis to reflect current project status
Organize, schedule, and facilitate cross-functional team meetings to exchange information, identify risks and chart progress of the project
Conduct lessons learned in form of Stage gate reviews and project close-out sessions to obtain information that can be used to improve future projects
Prepare and present the Progress Reports of the projects, identify project related issues and communicate to management & Global team in Project Review Meetings
An interface between various departments and management to facilitate allocation and prioritization of resources necessary to achieve objectives within established timelines, facilitate in improving collaboration between all project stakeholders
Participate in and contribute to the feasibility assessment of proposed new projects and ventures during the project evaluation process. Maintain a thorough understanding of the future pipeline products and their technologies, e.g. patent issues, manufacturing challenges, pricing and market dynamics barriers to entry
Other job assigned

Job requirements

Bachelor of pharmacy degree or above, 6 years+ of experience in pharmaceutical industry
Supervisory and project management experience, knowledge about basic project management processes and tools
Previous experience in drug product development
Fluent in oral English and effective communication
Strategic thinking and good planning skills
Performance driven
Self-motivated and able to motivate the team
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Regulatory Affairs Manager/Director

  • Location:Beijing
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

Propose registration strategy of drug products in China, Asian countries and America, including timeline, budget and acquire agreement of related stakeholders
Collect information of drug registration regulations, guidelines, change trend and share with the team
Build and maintain good relationship with health authorities, as well as keep effective communication
Support R&D team to conduct the studies according to related regulations and technical guidelines
Be responsible for the organization, monitoring of pre-clinical, clinical and other related outsourcing researches, to fulfill regulations requirements
Complete registration dossiers by guiding related stakeholders
Review of technology transfer documents and change controls.
Ensure submission of satisfactory and timely responses to deficiency letters
Be responsible for organization, coordination, implementation of authorities’ inspection according to registration-related regulation
For licensed products, prepare and co-ordinate timely submission of post licensing commitments and legal obligations of the Marketing Authorization Holder via appropriate procedures, e.g. renewals, annual reports, variations, responses to questions, PSURs etc.
Ensuring the upkeep of regulatory databases
Other job assigned

Job requirements

Bachelor of pharmacy degree or above
At least 8 years of experience in drugs registration
Fluent in oral English and effective communication
Strategic thinking and good planning skills
Performance driven
Self-motivated and able to motivate the team
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Clinical Project Manager/Sr. Manager

  • Location:Shanghai
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

Project planning—Create a project team, communicate final protocol and explain scientific approach/performance to the team (e.g. cost, time, quality).
• Project Monitoring and Guiding—Monitor/evaluate/review the scientific performance of the study.
• Project Problem Management—Suggest solutions and actions to solve study problems, manage the impact on time and cost, review protocol changes.
• Learn Process—Perform scientific mentoring activities (e.g. training study specific techniques, assisting with complex analytical work/problem solving). Participate in post project assessment by providing input on team performance (accomplishments and glitches). Responsible for the design, conduct and reporting of studies to meet scientific, regulatory requirement.
• Initiate a long-range planning and technical policies of the department
• Responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and timeline, and for managing the clinical portion of the study budget.
• Responsible in resource allocation, task oversight and delegation, development of monitoring plans, contingency planning, and management of communications and reporting.
• Lead in preparation and delivery of study documents for example SDV plan, study management plan for deliverables, confidentiality agreement and clinical trial applications.
• Provide clinical monitoring expertise and leadership for large, complex protocols and/or international programs
• Lead and motivate the clinical team. Act as a mentor and train CRA in the responsibilities of the position
• Promote effective teamwork among project team members
• Provide performance evaluation and feedback of team members
• Work independently and to effectively prioritize tasks, actively seek input, problems solve and work within a matrix team environment
• Effective verbal and written communication skills. Highly effective interpersonal and organization skills. Effective presentation skills, is able to prepare a presentation for an investigators meeting.
• Coordinate operational aspects of study and lead and participate in activities and ensure quality, consistency, and integration of study data and progress deliverables to time cost and quality from study concept through database lock and study close-out activities.
• Provide input into non-project work, training activities, and development of procedure as needed.
• Manage external service provider.
• Help in the development and implementation of plans associated with audits and regulatory inspections.
• Planning and conduct of investigator/monitors meetings.
• Manage/coordinate the supply and reconciliation of Study Materials and Investigational product.
• Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.
• Quality contact person of the department and in charge on the development and implementation of all SOP
• Assist the staff recruitment
• Assist in business development in proposal generation and undertake feasibility work.
• Perform other related duties as assigned.

Job requirements

• Experience conducting clinical trials with strong knowledge of GCP/ICH-GCP guidelines
• Experience making decision on the detailed execution of clinical trials
• Proven clinical trial experience with more than 3 years project management
• Medical life science background
• Fluent English is preferred
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Public Relations Manager/Sr. Manager

  • Location:Shanghai
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

Responsible for designing and implementing corporate promotion, brand communication and other plans.
Responsible for planning and managing channels, forms, monitoring and summaries of the corporate branding.
Responsible for the content design of the company's PR platforms (including official website, WeChat); coordinate the release of the final version, and coordinate the online and offline strategic cooperation of the official website, media, etc.
Responsible for establishing corporate culture and implementating activities in PR platforms, including the writing and publicity of hot events and news of the company and departments.
Be responsible for the output of relevant project materials, such as company brochure, leaflet page, meeting manual, etc.
Maintain the media relations in the industry, establishing effective promotion channels and assisting in participating in the company's market activities.
Be responsible for maintaining government relations, including activity planning and participation, implementation of government public relations, etc.
Responsible for establishing, maintaining and tracking the dynamic information of the enterprise, and filing.
Other assignments.

Job requirements

Be familiar with the creative, planning and implementation workflow of marketing activities, and have the ability of marketing activities planning and operation.
Fluent in Chinese and English, with a very solid foundation in writing, accurate and original in writing, rigorous in logic, able to independently complete the planning and writing of media plans and various manuscripts.
With unique ideas, innovative ideas, high sense of responsibility and execution; good communication skills and team spirit.
Familiar with pharmaceutical or investment industry, with working experience in domestic (Overseas) listed companies.
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Sr. Investor Relations Manager

  • Location:Shanghai
  • Released Time:2020-11-20
  • Number of Hire:1
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Job description

Responsible for the establishment and improvement of the investor relationship management system.
Keep the track record of existing/potential investors and collect updates from business departments on a regular basis.
Responsible for investors visits, interviews and researches.
Participate in organizing IR related events including performance presentations, internet conferences and road shows; actively develop and maintain good relations with investors and industry analysts.
Participate in corporate financing activities with knowledge of capital market.
Participate in brokerage strategy meetings, investor relations meetings, and regularly visit major investment institutions to ensure that the capital market understand the company's dynamics timely, objectively and comprehensively.
Assist to advance future IPO procedures and responsible for information disclosure and compliance related to listed company.
Pay attention to the media reports on the listed entity, take the initiative to verify the contents of the reports with the company and relevant information disclosure obligors, and urge the Board of Directors to disclose them in time.
Formulate and improve the company's information disclosure management derective.
Take the lead in organizing the company's management team and intermediary team to draft, revise and disclose the periodic and irregular reports that should be disclosed according to the listing rules.
Formulate and implement the market value management plan for the listing entity.

Job requirements

Relevant experience in HK listed company is a plus. Direct experience in VC or PE is preferred.
In-depth understanding of biopharmaceutical industry in China and globe.
Strong analytical, writing, communication and presentation skills.
Knowledge in HK listing rules.
Good at capturing market information and sensitive in data analysis.
Ability to work in a fast-paced environment and able to cope with pressure.
Fluent English in oral and writing.
Bachelor degree or above in biology, finance, legal and other related majors. MBA is a plus.
At least 5 years working experience in IR work
Familiar with pharmaceutical or investment industry, with working experience in domestic (Overseas) listed companies
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