Trial Activation Approval Specialist II/SSU II at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Beijing, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

0.0

Posted On

10 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Submission Strategy, Project Coordination, Client Communication, Feasibility Activities, Patient Information, Informed Consent, Safety Dossiers, Import License, Gene Therapy Approvals, Internal Communication, Timely Submissions, Issue Resolution, Budget Negotiation, Study File Management, SOP Knowledge

Industry

Biotechnology Research

Description

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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Responsibilities

The Trial Activation Approval Specialist II/SSU II prepares, reviews, and coordinates submissions in alignment with global submission strategy while providing strategic advice to clients. They serve as the primary contact for investigators and local authorities, ensuring timely management of submissions and alignment with site activation processes.