Job Overview
Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.
Essential Functions
- Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff.
- Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
- Experienced in Regulatory knowledge in Chemistry, Manufacturing & Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable.
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
- Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.
- Understands the Scope of Work, deliverables for any given project.
- May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person.
- May prepare and deliver trainings, as appropriate.
- Performs other tasks or assignments, as delegated by Regulatory management.
- Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex.
Qualifications
- Bachelor's Degree in Lifescience or related discipline (concluded).
- Master's Degree in Lifescience or related discipline is a plus.
- At least 2 - 3 years relevant experience in Regulatory Affairs in general, Publishing, Word Formatting, Clinical PDF Publishing, Submission Publishing activities.
- Fluent English (writing, speaking, reading).
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
- Good, solid interpersonal communication (oral and written) and organization skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable.
- Demonstrates self-motivation and enthusiasm.
- Ability to work on several projects, with direction from senior staff as appropriate.
- Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements.
- Ability to make decisions on discrete tasks under senior supervision.
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex.
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.
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 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as an Associate Site Contract Specialist - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to assist in the preparation, negotiation, and finalization of contracts with investigative sites. As an Associate Site Contract Specialist, you'll liaise and establish effective relationships with internal functional teams.
What You'll Do:
- Drafts, reviews, negotiates and finalizes amendments and budgets with study sites in accordance with local/accepted process.
- Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with contractual considerations, client contractual considerations, established process with clients and follows established escalation routes.
- Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations.
- Ensures compliance of budgetary guidance, templates and process.
- Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
- Achieves target cycle times for site activations.
- Ensures guidelines and processes are followed for efficient escalation of out of parameter issues, as applicable.
- Completes tracking and reporting as required and assists all other specialists with tracking and reporting as required
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