Clinical Affairs Specialist III

Work Schedule

Environmental Conditions

Job Description

Job Title: Clinical Affairs Specialist III, in vitro diagnostics (IVD)

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

The position is in Japan and is part of the Regulatory and Clinical Affairs organization. This position ensures that the internal and external clinical work performed to develop IVD products, follow Good Clinical Practice, and applicable clinical and regulatory requirements (domestically and internationally) and is submitted to the PMDA in a complete, accurate, and timely manner for approvals in support of the business units.

How will you make an impact?

Your work will impact the quality of the PMDA submissions and help secure the vital approvals for our products to be marketed and reach the patients who will ultimately benefit from these diagnostics.

What will you do?

The primary role of this position is targeted toward clinical studies support and study site management. In this role, the primary responsibilities include:

For all projects, you will participate in discussions and prepare documentation for PMDA concerning project clinical studies along with the Sr Manager of RA/ Clinical.

• For projects where the team performs clinical studies in multiple time zones, you will represent requirements for Japan clinical study/submission content.
• Provide the requirements for PMDA clinical submission content.
• Ensuring studies are conducted and detailed by the study protocol, standard operating procedures, Ethical Guidelines, and other applicable regulatory requirements.
• Prepare site study binder and collect all clinical study documents. Ensure that test site activities and timelines are in coordination with project requirements. Document communication with laboratories to ensure project progress.
• Real-time communication of Clinical studies issues to Sr. Manager of RA
• Ensure compliance with department and company SOPs.
• Performing lab assessment and monitoring visits both remotely and in person.
• Coordinate and conduct activities involved in initiating, monitoring, and completing clinical research studies for IVD products.

How will you get here?

Education

• A minimum B.Sc. degree in Biology, Pharmacology, Chemistry, bio-engineering or related science.
• A confirmed understanding of Ethical Guidelines for Medical and Health Research Involving Human Subjects is required.

Experience

• 3-5 years minimum working in the IVD or Medical Device Industry and experience in supporting the management of in-house and/or external clinical studies. In Vitro diagnostic experience is a plus.
• Experience working with multi-functional project teams is required.
• Experiences in Oncology, Companion diagnostics, PCR/NGS preferred.
• Knowledge of PMDA clinical requirements for In-Vitro Diagnostic/ Medical Device and Companion Diagnostics; direct/ positive experience with PMDA, MHLW, and the affected authorities.

Knowledge, Skills, Abilities

• Ability to adjust the schedule to work with multiple time zones
• The candidate must be an independent professional who proactively communicates as needed. Should be at ease with direct communication with internal project team members and external test sites
• Ability to work on multiple projects with specific timelines.
• Required language skills: Proficient in Japanese. Business-level English (oral and written) is desirable.
• High energy level; positive demeanor; works well under stress; and effective communicator.
• Hands-on, committed, and able to implement efficiently.
• Digital literacy, including spreadsheet, database, and word processing applications required.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.