400-885-9898
职位描述
药品临床研究
Job Description
Key responsibilities:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Knowledge, Skills and Abilities:
Key responsibilities:
- Prepares, review and coordinates submissions (MoH, EC, applications if, e.g. gene therapy approvals, safety dossiers, import license) in alignment with global submission strategy.
- Provides strategy advice (MoH &/or EC) to clients.
- Develops and implements local submission strategy. Provides expertise and coordination oversight for projects in collaboration with relevant internal departments.
- Serves as primary contact for investigators and with the local authorities (in collaboration with the local regulatory manager for sophisticated issues) to ensure submissions are managed in a timely manner.
- Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
- Acts as a key-contact at country level for all submission-related activities.
- Participates as the need arises in Submission Team Meetings, Review Meetings and Project Team meetings.
- Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPD’s target cycle times for site activations.
- Prepares the regulatory compliance review packages, as applicable.
- Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
- Develops country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
- Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
- Oversees country study files and ensures that they meet PPD WPD’s or client SOP’s.
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- Advises/mentos other SIA individuals assigned to support projects of responsibility, as appropriate
- Proactively identifies issues or anomalies in the regulatory process of a study, resolves or escalates as appropriate.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Knowledge, Skills and Abilities:
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good digital literacy and the ability to learn appropriate software
- Good English language and grammar skills
- Good judgment and decision-making skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, with minimal direction, as required
- Ability to mentor fellow SIA team members in a positive and effective manner
- Excellent team player with teambuilding skills
- Basic organizational and planning skills
- Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations
工作地点
广东省广州市海珠区生物岛寰宇三路3638号
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职位发布者
王李娟/人事经理
昨日活跃立即沟通
赛默飞世尔科技ThermoFisher Scientific Inc.(NYSE: TMO) is the world leader in serving science, withrevenues of$17 billion and approximately 50,000 employees in 50 countries. Ourmission is to enable our customers to make the world healthier, cleaner andsafer. We help our customers accelerate life sciences research, solve complexanalytical challenges, improve patient diagnostics and increase laboratoryproductivity. Through our premier brands– Thermo Scientific, AppliedBiosystems, Invitrogen, Fisher Scientific and Unity Lab Services– we offer anunmatched combination of innovative technologies, purchasing convenience andcomprehensive support. For more information, please visit www.thermofisher.com
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