Top 404 Regulatory specialist Jobs in Morrisville Nc

Sponsor Dedicated Regulatory & Start-Up Specialist 2
IQVIA —Durham, NC
- $60,300 - $157,100 a year
- Full-time
- Remote
- Mid-level
- Bachelor's degree
- 1 year
- Work from home
8d
QA Specialist (Hybrid)
Eisai —Raleigh, NC
- $66,200 - $86,800 a year
- Full-time
- Hybrid work
- Mid-level
- Bachelor's degree
- Continuous improvement
Data Review (QC Specialist) 6-Mo Contract
BioAgilytix —Durham, NC
- Contract
- Mid-level
- Master's degree
- Bachelor's degree
- Health savings account
- Paid holidays
Quick Apply
1d
Clinical Nurse Leader (MIDS) - Emergency Department
Duke Health —Durham, NC
- Full-time
- Nursing
- RN License
- Computer literacy
- Opportunities for advancement
Field Technician – Fall Protection Systems
Diversified Fall Protection —Raleigh, NC
- $28 - $32 an hour
- Weekends as needed
- Background check
- Heavy lifting
- Construction site
- Disability insurance
- Health insurance
Quick Apply
11d
Environmental Specialist
Triumvirate Environmental —Raleigh, NC
- Overtime
- Military
- Pass drug screening
- Mid-level
- Health insurance
- Dental insurance
Senior EHS Specialist - Environmental and Sustainability
Millennium Print Group —Raleigh, NC
- Full-time
- 5 years
- Analysis skills
- Bachelor's degree
- AD&D insurance
- Paid holidays
Quick Apply
7d
RSVP - W2 Life Insurance Specialist - Remote - Hiring Event
Insurance Supermarket Inc. —North Carolina
- $38,500 - $180,000 a year
- Full-time
- Computer literacy
- Mid-level
- Communication skills
- Health insurance
- Paid time off
Escrow Post-Closer
Investors Title Insurance Company —Chapel Hill, NC
- Full-time
- Mid-level
- Office
- Residential
Quick Apply
Clinical Nurse IV Leader - Emergency Department
Duke Health —Raleigh, NC
- 12 hour shift
- Nursing
- RN License
- Computer literacy
7d
ACH Specialist
North State Bank —Raleigh, NC
- Full-time
- Microsoft Word
- Bachelor of Science
- Research
8d
Assistant Nurse Manager - Cardiology Stepdown
Duke Health —Durham, NC
- Nights as needed
- Nursing
- RN License
- BLS Certification
- Relocation assistance
- Loan forgiveness
Sr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3
Alcami Corporation —Morrisville, NC
- 12 hour shift
- 5 years
- Master's degree
- Databases
Cardiovascular Specialist - Rex Invasive Heart & Vascular
UNC Health —Raleigh, NC
- $33.04 - $47.50 an hour
- Full-time
- Hospital
- Mid-level
- ACLS Certification
Cardiovascular Invasive Specialist Cardiac EP Lab
Duke Health —Durham, NC
- Full-time
- Computer literacy
- BLS Certification
- Mid-level
- Relocation assistance
Customer Assistance Specialist
Thermo Fisher Scientific —Morrisville, NC
- Weekends as needed
- Office
- High school diploma or GED
- Driving
2d
Medical Communications Customer Assistance Specialist
Thermo Fisher Scientific —Morrisville, NC
- Full-time
- Office
- High school diploma or GED
- Driving
Planned Activity Project Manager - Cary, NC
Siemens Healthineers —Cary, NC
- $74,350 - $102,234 a year
- Full-time
- Microsoft Outlook
- Mid-level
- Bachelor's degree
- Disability insurance
- Health insurance
7d
Senior Specialist – Investigations & Regulatory Inspections
Amgen —Holly Springs, NC
- $137,263.10 - $185,708.90 a year
- Doctoral degree
- Engineering
- Master's degree
- Disability insurance
- Health insurance
Remote Collection Specialist
AADVANTAGE LAUNDRY SYSTEMS LLC —Raleigh, NC
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- Mid-level

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Sponsor Dedicated Regulatory & Start-Up Specialist 2

IQVIA -
Durham, NC

Apply Now

Job Details

Full-time
$60,300 - $157,100 a year
8 days ago

Benefits

Work from home

Qualifications

Research project management
Team leadership
Client rapport building
Employee relationship building
ICH guidelines
Clinical research compliance
Project management experience in healthcare
Managing projects
Clinical quality assurance standards
Standard operating procedures (SOPs)
Negotiation
Stakeholder relationship building

Full Job Description

Durham, United States of America | Full time | Home-based | R1562501

Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor's Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
In-depth knowledge of clinical systems, procedures, and corporate standards.
Good negotiating and communication skills with ability to challenge, if applicable.
Effective communication, organizational, and interpersonal skills.
Ability to work independently and to effectively prioritize tasks.
Ability to manage multiple projects.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $60,300.00 - $157,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Where you'll work

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

Apply Now

Refine Your Search

regulatory specialist jobs in morrisville nc

Sponsor Dedicated Regulatory & Start-Up Specialist 2

QA Specialist (Hybrid)

Data Review (QC Specialist) 6-Mo Contract

Clinical Nurse Leader (MIDS) - Emergency Department

Field Technician – Fall Protection Systems

Environmental Specialist

Senior EHS Specialist - Environmental and Sustainability

RSVP - W2 Life Insurance Specialist - Remote - Hiring Event

Escrow Post-Closer

Clinical Nurse IV Leader - Emergency Department

ACH Specialist

Assistant Nurse Manager - Cardiology Stepdown

Sr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3

Cardiovascular Specialist - Rex Invasive Heart & Vascular

Cardiovascular Invasive Specialist Cardiac EP Lab

Customer Assistance Specialist

Medical Communications Customer Assistance Specialist

Planned Activity Project Manager - Cary, NC

Senior Specialist – Investigations & Regulatory Inspections

Remote Collection Specialist

I want to receive the latest job alert for regulatory specialist in morrisville nc

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