Principal CAS (Principal SSU) at Thermo Fisher Scientific

Beijing, Beijing, China

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, BiotechnologyIndustries

Requirements

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)
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

Responsibilities

Prepares, reviews 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
Liaises 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 understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
Advises/mentors 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

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsMoH CoordinationEC ApplicationsSubmission StrategyRegulatory ComplianceSite ActivationInformed ConsentGrant BudgetsProject CoordinationLocal Authority Liaison

Questions & Answers

Common questions about this position

What is the work arrangement or location for this role?

This is a full-time position with a standard Monday-Friday schedule in an office environment.

What education and experience are required for this position?

A Bachelor's degree or equivalent relevant formal academic/vocational qualification is required, along with previous experience that provides the necessary knowledge, skills, and abilities.

What are the main responsibilities of the Principal CAS role?

The role involves preparing, reviewing, and coordinating country submissions in line with global strategy, providing strategy advice to clients, developing local submission strategies, and serving as the primary contact for investigators and local authorities.

What is the salary or compensation for this position?

This information is not specified in the job description.

What makes a strong candidate for this Principal CAS role?

Strong candidates will have a Bachelor's degree with relevant experience in regulatory submissions, the ability to provide strategy advice, coordinate with internal teams and authorities, and maintain knowledge of PPD and client SOPs and regulatory guidelines.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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