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PAREXEL International Corporation Job Title
Principal Compliance Consultant - Cell & Gene therapies / Biologics

Company
PAREXEL International Corporation

Job Description
Fraud Notice
Parexel.com
Own the challenges that lead to innovation and growth
2020
Promoted to Head of Biotech Operations for Americas East, helping clients develop novel therapies with a focus on patient needs.
2019
Advanced to Corporate VP Clinical Operations to lead Site Monitoring for Americas, Europe and SE Asia.
2018
Streamlined Parexel’s clinical operations model; driving effectiveness, and increasing employee, client and site satisfaction.
2016
Promoted to VP Clinical Operations, and relocated to the US in 2017.
2013
Promoted to Senior Director of Clinical Operations for the Americas, consolidating both North and South American regions.
2012
Joined Parexel as Director of Global Monitoring Operations for Latin America.
Create the solutions that drive global projects to success
2020
Promoted to Senior Director, Project Management. Taking on management responsibilities for dedicated Enterprise accounts and enhancing his contributions to Parexel’s Global Project Leadership.
2019
Managing Project Director role for dual Enterprise accounts, with a focus on client delivery and satisfaction in order to bring in new awards and expand growth.
2017
Assumed the role of Global Project Leadership Training Coordinator, ensuring new PLs are properly inducted in all regions, while leading cross regional meetings to review and update training materials for PLs.
2015
Promoted to Associate Director in Project Management at Parexel working on post-approval smoking cessation treatment.
2012
Joined Parexel as a Senior Project Lead mentoring and managing 5 project managers working on a phase IV smoking cessation treatment.
Be part of a diverse team that drives healthcare innovation
2018
Advanced into Senior Manager, Human Resources
2015
Promoted to Manager, Human Resources Operations
2014
Joined Parexel as a Human Resources Operations Partner.
2013
Human Resources Business Partner at leading pharmaceutical company.
1999
Manager of Diversity Resources.
Contribute to meaningful advances that benefit patients in need
2020
Joined the Scientific Data Organization as Scientific Data Technology Director, creating agile access to real world data, bringing best in class technology solutions to Parexel services, and harnessing data to transform therapy development for patients.
2017
Promoted to Director IT Project and Programme Office, leading engineering projects for Wearable and Sensor devices with a view to streamlining Clinical Trials patient engagement and approaches.
2016
Promoted to Associate Director of IT Program and Project Management at Parexel.
2013
Joined Parexel as a Project Manager in the IT Project Program Office.
Own the challenges that make you grow
2020
Promoted to Senior Medical Writer, focusing on the development and support of clinical documents intended for regulatory submission.
2017
Began a new role working remotely as a Medical Writer II, researching and coordinating the development of clinical documents intended for submission to the FDA or other regulatory authorities.
2015
Director of Imaging Operations leading a team of 13 Project Managers and the imaging of over 130 clinical trials.
2007
Senior Project Manager, overseeing standardization of program operations and deliverables while leading a team of Project and Imaging Research Managers.
2004
Promoted to Project Manager for clinical oncology trials.
2003
Joined Parexel as an Imaging Research Associate on clinical trials utilizing medical imaging.
Forge the relationships that elevate customer experience
2020
Corporate Vice President, General Manager – Japan
2019
Vice President, Growth Accounts
2016
Senior Director of Business Development at Parexel.
2003
Associate in the Proposal Development department at Parexel.
2000
One of the founders and Marketing Director of an IT venture company developing web related systems
Voice the ideas that get treatments to patients faster
2014
Promoted to Senior Director of Clinical Application Development and Technology.
2009
Promoted to Associate Director of IT.
2004
Promoted to Senior Programmer.
2001
Joined Parexel in Clinical IT.
1995
Received Master's in Computer Applications.
Own the challenges, program your future
2020
Promoted to Senior Manager, Statistical Programming FSP, with increasing responsibilities for department development and team supervision.
2018
Advanced to Statistical Programming Manager, responsible for a dynamic, multinational team of over 12 people.
2017
Increased responsibility, leading projects and managing small teams as a Principal Statistical Programmer / Associate Manager.
2016
Promoted to Senior Statistical Programmer, participating in high profile trials for diverse range of sponsors, as main programmer.
2013
Referred by a friend to join Parexel as a Statistical Programmer, taking the opportunity to further develop my programming skills in 4GL language using SAS® .
Natalia – Head of Biotech Operations for Americas East
Ruben – Senior Director
Project Management
Deborah – Senior Manager
Human Resources
Martin
Scientific Data Technology Director
Nicholas – Senior Medical Writer
Shigehiro – Corporate Vice President, General Manager – Japan
Naresh – Senior Director of Clinical Application Development
and Technology
Pawel – Senior Manager
Statistical Programming
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Principal Compliance Consultant - Cell & Gene therapies / Biologics
USA - Any Region - Home Based
Date posted
12/12/2021
Job ID
75269BR
Apply Now
Overview
Success Profile
Rewards
Responsibilities
Map
Recent Jobs
As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
Full Time
Travel: Yes
Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we're looking for and see if you have the right mix.
Detail-Oriented
Proactive
Problem-Solver
Results-Driven
Organized
Multi-Tasker
"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."
Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"
Riley – Regulatory Affairs Consultant
Rewards
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Collaboration
Work with industry leaders and subject matter experts.
Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Variety
Opportunities to work on multiple accounts – never boring!
Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Parexel’s Regulatory Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Regulatory Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing!

We currently have a home-based opening on our Regulatory Compliance Team for a highly experienced Cellular and Gene Therapy / Biologics Compliance Expert to join the Parexel Regulatory Consulting team as Principal Consultant.

A Principal Consultant will have the knowledge and ability to provide clients with recommendations on how to bring their processes and procedures into compliance with cGMPs and industry best practices; the ability to write clear, concise, objective reports and recommendations; and effectively communicate and interact with our clients at all levels within their organization.

A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. A Principal Consultant provides a full range of consulting services and works within their personal area of expertise. A Principal Consultant provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC.

We are currently seeking experts with past experience helping pharmaceutical and biopharmaceutical companies to manage and prepare for FDA inspections and to manage post inspection activities.

To include specialized experience in the following: Implementation of compliant Quality Systems
Audits: Sponsor-Monitor Audits (Drugs and Biologics)
Clinical Investigator Audits (Drugs and Biologics)
CRO Audits (Drugs and Biologics)
Drug and Biologic GMP Audits
Data Integrity Assessments
Assist in the preparation of written responses and remediation plans to address FDA-483 Inspectional Observations and Warning Letters
On-Site guidance during FDA inspections
Review of study protocols and recordkeeping documents for clinical site use
Preparation for Discussion of Regulatory Compliance Matters with FDA
Compliance Remediation strategy and implementation
Qualifications
Education:
-PhD in a in a scientific discipline or other advanced degree or equivalent in engineering with 12-15 years of experience; may include post doctoral experience, preferred.

Knowledge and Experience:
- Reputation as emerging leader in field with sustained performance and accomplishment
- Expertise and experience in cellular and gene therapy, and emerging markets and regulatory expectations and for the US, EU and APAC markets, is a plus
- Previous Industry experience in Quality and/or Compliance or previous experience as a Consumer Safety Officer, BIMO and/or Compliance Investigator, or similar role to include numerous years’ experience planning and conducting complex regulatory inspections and in-depth investigations coupled with expert level industry or regulatory knowledge experience with a regulatory agency (such as FDA, MHRA) are required.
-Expert knowledge of scientific principles and concepts.

Skills:
-High-level consulting skills
-Critical thinking and problem-solving skills
-Project leadership and management knowledge
-Excellent interpersonal and intercultural communication skills, both written and verbal
-Client-focused approach to work
-Results orientation
-Teamwork and collaboration skills
-Proficiency in local language and extensive working knowledge of the English language
-Account planning and support
-Networking
-Business acumen and analysis
-Self-confidence and control

Up to 70% Domestic and International Travel Required

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Apply Now
Save Job
FAQ: Hiring during COVID-19
Learn how we recruit the best minds in these unprecedented times.
Learn More
COVID-19: Working from home
One year of learnings and support — an interview with Parexel colleagues on working in these unprecedented times
Learn More
Flexible Work Arrangement
In-office, home-based or a mix? What’s your preference? We value the work-life balance of our employees, and as such Parexel is offering maximum flexibility to our employees wherever possible.
Learn More
'Corporate Equality Index' 2021
Parexel ranks in the top 20 percent on the Human Rights Campaign Foundation’s 2021 Corporate Equality Index for LGBTQ Workforce Equality
Learn More


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