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CMC Regulatory Affairs Associate at Katalyst Healthcares Life Sciences
North Chicago, IL 60064, USA - Full Time
Skills Needed
Completion, Manufacturing Processes, Batch Records, Clinical Trials, Impd
Specialization
The field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Test Lead || Validation at Katalyst Healthcares Life Sciences
King of Prussia, Pennsylvania, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
Computer science sciences or a related education (e.g
Qualification
Graduate
Quality Engineer at Katalyst Healthcares Life Sciences
Chicago, Illinois, USA - Full Time
Skills Needed
Decision Making, International Standards, Regulations, Interpersonal Skills, Quality System, Iso, Infusion Pumps, Pfs, Medical Devices, Combination Products
Specialization
Science engineering or other technical areas or equivalent job experience required
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Clinical Research Associate (CRA) I at Katalyst Healthcares Life Sciences
Grayslake, IL 60030, USA - Full Time
Skills Needed
Phlebotomy, Emt
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Senior Clinical Engineering Technologist at Buckinghamshire Healthcare NHS Trust
Aylesbury HP21 8AL, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Regional Nurse Consultant (RN) at Signature HealthCARE IN Indianapolis
Indianapolis, IN 46077, USA - Full Time
Skills Needed
Collaboration, Medicare, Medicaid, Clinical Skills, Role Modeling, Care Planning, Learning, Clinical Supervision, Patient Care, Training, Oversight
Qualification
Graduate
Caregiver, CBRF, CNA PRN at Interim HealthCare of the Fox Cities
Menasha, WI 54952, USA - Full Time
Skills Needed
Health, Cooking
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Design Quality Engineer at Katalyst Healthcares Life Sciences
San Francisco, California, USA - Full Time
Skills Needed
Confluence, Design Control, Iso, Jira, Slack, Risk, Iec
Qualification
Graduate
Quality Process Engineer at Katalyst Healthcares Life Sciences
Fair Lawn, NJ 07410, USA - Full Time
Skills Needed
Validation, Process Transfer, Gmp, Life Sciences, Communication Skills, Regulated Industry, Process Engineering, Chemistry
Specialization
Engineering chemistry life sciences or related technical field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
SAP Validation Lead at Katalyst Healthcares Life Sciences
Foster, California, USA - Full Time
Skills Needed
Gamp, Medical Devices, Change Management, Life Sciences, Security Controls, Record Keeping, Data Integrity
Qualification
Graduate
Experience Required
Minimum 8 year(s)
Validation Specialist Lab Equipment Qualification at Katalyst Healthcares Life Sciences
Boston, MA 02108, USA - Full Time
Skills Needed
Computerized Systems, Validation, Gamp, Life Sciences, Regulatory Audits, Equipment Qualification, Ema, Chemistry
Specialization
Review vendor-supplied documentation (fat/sat protocols manuals calibration certificates etc.
Qualification
Trade Certificate
Rehabilitation Services Program Director at HCA Houston Healthcare North Cypress
Cypress, TX 77429, USA - Full Time
Skills Needed
Ethics, Clinical Excellence, Color, Continuing Education, Accreditation, Financial Performance, Business Operations, Working Environment, Leadership, Healthcare Management, Mentoring
Specialization
Business Administration, Administration, Business
Qualification
Graduate
Validation Engineer at Katalyst Healthcares Life Sciences
Norwood, Massachusetts, USA - Full Time
Skills Needed
English, Functionality, Process Equipment, Engineering Drawings, Communication Skills
Specialization
Engineering
Qualification
Graduate
Electrical Systems Verification Engineer at Katalyst Healthcares Life Sciences
Greensboro, North Carolina, USA - Full Time
Skills Needed
Value Creation
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Part Time Administration Assistant at MedCo Secure Healthcare Services Ltd
SM6, , United Kingdom - Full Time
Skills Needed
Data Analysis, Medical Records, Microsoft Excel, Regulations, Spreadsheets, Pivot Tables, Communication Skills
Qualification
Graduate
Clinical Medical Services Specialist III at Katalyst Healthcares Life Sciences
Waukegan, IL 60079, USA - Full Time
Skills Needed
Customer Service, Professional Manner, Written Communication, Internal Customers, Project Work, Process Management, Technology, Communication Skills
Qualification
BSc
Experience Required
Minimum 2 year(s)
Clinical Data Manager at Katalyst Healthcares Life Sciences
Worcester, MA 01601, USA - Full Time
Skills Needed
Documentation, Sdtm, Clinical Trials, Regulatory Requirements
Specialization
Science or a related field
Qualification
Graduate
Marketing Director at Beauvais Rehab and Healthcare Center
St. Louis, MO 63110, USA - Full Time
Skills Needed
Leadership Skills, Excel, Discretion, Communication Skills, Organization Skills, Teams, Leadership, Microsoft Office, Regulations, Consideration, Computer Skills, Management Software, Compassion, English, Clinical Excellence, Group Presentations
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Senior Manager at Katalyst Healthcares Life Sciences
Tarrytown, New York, USA - Full Time
Skills Needed
Life Sciences, Pharmaceutical Industry, Communication Skills, Dmf, Computer Skills
Qualification
MSc
Lead Clinical Data Manager at Katalyst Healthcares Life Sciences
Phoenix, AZ 85001, USA - Full Time
Skills Needed
Interpersonal Skills, Cdisc Standards, Pharmaceutical Industry, Life Sciences, R, Statistical Software, Data Collection, Computer Science, Emerging Technologies, Project Management Skills, System Configuration, Sas
Specialization
Life sciences computer science or a related field advanced degree preferred
Qualification
Graduate
CMC Regulatory Affairs Associate at Katalyst Healthcares Life Sciences
North Chicago, IL 60064, USA -
Full Time

Start Date

Immediate

Expiry Date

10 Oct, 25

Salary

0.0

Posted On

11 Jul, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Completion, Manufacturing Processes, Batch Records, Clinical Trials, Impd

Industry

Pharmaceuticals

Description

COMPANY 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

REQUIREMENTS:

  • CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions.
  • IND/IMPD submission background based on manufacturing batch records.
  • Early Phase CMC knowledge a plus.
  • French/ English speaking a plus.
  • Experience Level = 3-5 Years.
  • Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
  • Technical writing skills.
  • Familiar with typical manufacturing processes, especially cell cultures.
  • Familiar with microbial methodology.
  • Familiar with ICH and country regulatory procedures for clinical trials.
  • Able to work with electronic systems i.e., Microsoft and dossier publication systems.
  • New manufacturing site in France due to acquiring new business . Contractor needed to complete 3 separate projects for CMC clinical/regulatory submissions. This was a previous commitment for completion from prior company.
    Additional Information
    All your information will be kept confidential according to EEO guidelines
Responsibilities
  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • May require an advanced degree and 3 to 5 years of direct experience in the field.
  • Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • May lead and direct the work of others.
  • A wide degree of creativity and latitude is expected.
CMC Regulatory Affairs Associate at Katalyst Healthcares Life Sciences
North Chicago, IL 60064, USA - Full Time
Skills Needed
Completion, Manufacturing Processes, Batch Records, Clinical Trials, Impd
Specialization
The field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Test Lead || Validation at Katalyst Healthcares Life Sciences
King of Prussia, Pennsylvania, USA - Full Time
Skills Needed
Good Communication Skills
Specialization
Computer science sciences or a related education (e.g
Qualification
Graduate
Quality Engineer at Katalyst Healthcares Life Sciences
Chicago, Illinois, USA - Full Time
Skills Needed
Decision Making, International Standards, Regulations, Interpersonal Skills, Quality System, Iso, Infusion Pumps, Pfs, Medical Devices, Combination Products
Specialization
Science engineering or other technical areas or equivalent job experience required
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Clinical Research Associate (CRA) I at Katalyst Healthcares Life Sciences
Grayslake, IL 60030, USA - Full Time
Skills Needed
Phlebotomy, Emt
Qualification
Diploma
Experience Required
Minimum 1 year(s)
Senior Clinical Engineering Technologist at Buckinghamshire Healthcare NHS Trust
Aylesbury HP21 8AL, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Regional Nurse Consultant (RN) at Signature HealthCARE IN Indianapolis
Indianapolis, IN 46077, USA - Full Time
Skills Needed
Collaboration, Medicare, Medicaid, Clinical Skills, Role Modeling, Care Planning, Learning, Clinical Supervision, Patient Care, Training, Oversight
Qualification
Graduate
Caregiver, CBRF, CNA PRN at Interim HealthCare of the Fox Cities
Menasha, WI 54952, USA - Full Time
Skills Needed
Health, Cooking
Qualification
Graduate
Experience Required
Minimum 1 year(s)
Design Quality Engineer at Katalyst Healthcares Life Sciences
San Francisco, California, USA - Full Time
Skills Needed
Confluence, Design Control, Iso, Jira, Slack, Risk, Iec
Qualification
Graduate
Quality Process Engineer at Katalyst Healthcares Life Sciences
Fair Lawn, NJ 07410, USA - Full Time
Skills Needed
Validation, Process Transfer, Gmp, Life Sciences, Communication Skills, Regulated Industry, Process Engineering, Chemistry
Specialization
Engineering chemistry life sciences or related technical field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
SAP Validation Lead at Katalyst Healthcares Life Sciences
Foster, California, USA - Full Time
Skills Needed
Gamp, Medical Devices, Change Management, Life Sciences, Security Controls, Record Keeping, Data Integrity
Qualification
Graduate
Experience Required
Minimum 8 year(s)
Validation Specialist Lab Equipment Qualification at Katalyst Healthcares Life Sciences
Boston, MA 02108, USA - Full Time
Skills Needed
Computerized Systems, Validation, Gamp, Life Sciences, Regulatory Audits, Equipment Qualification, Ema, Chemistry
Specialization
Review vendor-supplied documentation (fat/sat protocols manuals calibration certificates etc.
Qualification
Trade Certificate
Rehabilitation Services Program Director at HCA Houston Healthcare North Cypress
Cypress, TX 77429, USA - Full Time
Skills Needed
Ethics, Clinical Excellence, Color, Continuing Education, Accreditation, Financial Performance, Business Operations, Working Environment, Leadership, Healthcare Management, Mentoring
Specialization
Business Administration, Administration, Business
Qualification
Graduate
Validation Engineer at Katalyst Healthcares Life Sciences
Norwood, Massachusetts, USA - Full Time
Skills Needed
English, Functionality, Process Equipment, Engineering Drawings, Communication Skills
Specialization
Engineering
Qualification
Graduate
Electrical Systems Verification Engineer at Katalyst Healthcares Life Sciences
Greensboro, North Carolina, USA - Full Time
Skills Needed
Value Creation
Qualification
Graduate
Experience Required
Minimum 10 year(s)
Part Time Administration Assistant at MedCo Secure Healthcare Services Ltd
SM6, , United Kingdom - Full Time
Skills Needed
Data Analysis, Medical Records, Microsoft Excel, Regulations, Spreadsheets, Pivot Tables, Communication Skills
Qualification
Graduate
Clinical Medical Services Specialist III at Katalyst Healthcares Life Sciences
Waukegan, IL 60079, USA - Full Time
Skills Needed
Customer Service, Professional Manner, Written Communication, Internal Customers, Project Work, Process Management, Technology, Communication Skills
Qualification
BSc
Experience Required
Minimum 2 year(s)
Clinical Data Manager at Katalyst Healthcares Life Sciences
Worcester, MA 01601, USA - Full Time
Skills Needed
Documentation, Sdtm, Clinical Trials, Regulatory Requirements
Specialization
Science or a related field
Qualification
Graduate
Marketing Director at Beauvais Rehab and Healthcare Center
St. Louis, MO 63110, USA - Full Time
Skills Needed
Leadership Skills, Excel, Discretion, Communication Skills, Organization Skills, Teams, Leadership, Microsoft Office, Regulations, Consideration, Computer Skills, Management Software, Compassion, English, Clinical Excellence, Group Presentations
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Senior Manager at Katalyst Healthcares Life Sciences
Tarrytown, New York, USA - Full Time
Skills Needed
Life Sciences, Pharmaceutical Industry, Communication Skills, Dmf, Computer Skills
Qualification
MSc
Lead Clinical Data Manager at Katalyst Healthcares Life Sciences
Phoenix, AZ 85001, USA - Full Time
Skills Needed
Interpersonal Skills, Cdisc Standards, Pharmaceutical Industry, Life Sciences, R, Statistical Software, Data Collection, Computer Science, Emerging Technologies, Project Management Skills, System Configuration, Sas
Specialization
Life sciences computer science or a related field advanced degree preferred
Qualification
Graduate