Regulatory Associate

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life To enable 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 lifechanging therapies. As part of our clinical research portfolio our CorEvitas evidencebased solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on now and in the future.

Location/Division Specific Information

#CorEvitas

Discover Impactful Work:

As a Regulatory Compliance Associate you will work collaboratively across multiple CorEvitas departments to support the Quality and Regulatory Compliance team in ensuring CorEvitas compliance with regulations IRB and sponsor obligations and ethical standards for research while maintaining consistency and quality across regulatory site and patientfacing materials.

A day in the Life:

• Supporting in the preparation and filing of regulatory documents across the study lifecycle including but not limited to:
  • Protocol and data collection tool development
  • Translation requests
  • Deviation reports
  • Continuing review requests and site closure requests
• Supporting quality and compliancerelated work at the study level including but not limited to:
  • Verifying completeness of site master files and maintaining over the course of the study
  • Performing document control including versioning filing and archiving of controlled study documents and Standard Operating Procedures
  • Answering siterelated compliance questions
• Support Quality & Regulatory Compliance Team in regulatory matters.
• Attending team meetings; taking notes and tracking departmental action items
• Performs other duties as assigned.

Keys to Success:

Education

• Bachelors Degree preferred;

Experience

• 2 years of administrative experience in Research required.
• Experience with IRB communication and employee training.

Knowledge Skills Abilities

• Excellent verbal and written communication skills
• Excellent problemsolving skills
• Proven ability to manage multiple projects simultaneously without losing track of details
• Proficient with MS Office Word PowerPoint and Excel (knowledge of SharePoint and Salesforce a plus)
• Ability to work collaboratively in a remote setting

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

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

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other nondisability related technical issues will not receive a response.