Regulatory Systems Consultant Job at Katalyst Healthcares & Life Sciences, Groton, CT

VnJXNDZjZkZzYndxeHkrOW5oRmhicnd4SVE9PQ==
  • Katalyst Healthcares & Life Sciences
  • Groton, CT

Job Description



 

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Job Details:

  • Must Have Skills (Top 3 technical skills only)
  • Regulatory Submissions
  • eCTD, Volume 3
  • Pharma Chemistry Manufacturing and Controls (CMC)
  • Nice to have skills (Top 2 only)
  • Good documentation skill
  • Good communication skills

Education/ Certifications (Required):

  • BS/MS, Life sciences, pharma, biotechnology or relevant experience

Top 3 responsibilities you would expect the subcon to shoulder and execute:

  • DocSet Issues, Market View Issues, Supporting Document Issues, Market Impact Assessment Issues, Document Outline Issues, Product Change Form (PCF) Issues, Metadata Issues, Reporting Issues.
  • Data changes include updates to metadata, updating/correcting creation of change control forms, market assessments, impact assessments in collaboration with strategists/SMEs in the business. May also need creation/set up of product dossiers.
  • Periodic updates to stakeholders

Desired years of experience:

  • 5+ years

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

Similar Jobs

ExpressPros - Madison

Diesel Truck and Equipment Mechanic Job at ExpressPros - Madison

 ...is seeking a skilled and dedicated Diesel Truck and Equipment Mechanic for our client in Madison, WI! Our client is a leading metal...  ..., and emergency repairs to minimize downtime. Troubleshoot hydraulic, electrical, and mechanical issues on loaders, excavators, skid... 

NS2 Mission

Senior Network Administrator Job at NS2 Mission

View JobSenior Network AdministratorFull TimeChantilly VA 20151 USAPosted 03/12/2025Job Descriptionback to topAre you a tech-savvy problem solver with a passion for maintaining and optimizing IT networks? NS2 Mission is seeking aSeniorNetwork Administratorto... 

NRTC

Program Manager (Remote) Job at NRTC

 ...customers, and include integrated broadband, managed services, smart grid, mobile and video...  ...office locations. Job Summary The Program Manager will provide oversight and coordination...  ...sites on a regular basis (30%) Hybrid remote position Disclaimer: The above job... 

AO Globe Life

Work From Home Customer Service Representative Job at AO Globe Life

 ...We are looking for a motivated and customer-focused Work From Home Customer Service Representative to assist clients with their insurance needs. You will provide product recommendations, ensure a seamless customer experience, and work independently while meeting sales... 

Oldcastle Infrastructure

Market Intelligence Analyst - Atlanta, GA Job at Oldcastle Infrastructure

 ...Exempt Oldcastle Infrastructure , a CRH company, is the leading provider of utility infrastructure solutions for the water, energy, and communications markets throughout North America. Were more than just a manufacturer of precast concrete, polymer concrete...