Startup Lead at Thermo Fisher Scientific

Shanghai, Shanghai, China

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

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 and/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 and payment schedules negotiations with sites
Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advises 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 ApplicationsGene Therapy ApprovalsSafety DossiersImport LicenseSubmission StrategyRegulatory ComplianceInformed Consent FormsSite ActivationProject CoordinationStakeholder Liaison

Questions & Answers

Common questions about this position

What is the work schedule for this Startup Lead position?

The position is full-time with standard office hours of 40 hours per week in an office environment.

What education and experience are required for this role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous experience comparable to 5+ years that provides the necessary knowledge, skills, and abilities.

What key skills are needed for the Startup Lead position?

Effective oral and written communication skills are required.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for the Startup Lead role?

Candidates with a Bachelor's degree, 5+ years of relevant experience, and strong oral and written communication skills who can handle regulatory submissions, strategy development, and coordination with authorities and teams will stand out.

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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