CONTRIBUTE TO MEANINGFUL ADVANCESTHAT BENEFIT PATIENTS IN NEED
2014
Vice President of Integrated Product Development, leading a team of global regulatory affairs experts to help clients develop products more quickly and reach patients in need.
2006
Co-founder of a specialty pharmaceutical company focusing on developing orphan indication products.
1998
Director at several biopharmaceutical companies. Coordinated large clinical studies that spanned 6 continents, 30 countries, and 200 sites related to phase III sepsis and inflammatory disease studies.
1988
Intensive Care Clinical Nurse in Oncology ICU participating in clinical trial data collection for phase I, II, and III studies.
1979
Nurse’s Aide in Intensive Care Oncology Unit.
CREATE THE SOLUTIONSTHAT DRIVE GLOBAL PROJECTS TO SUCCESS
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.
2016
Project Director for a variety of studies ranging from cardiovascular to pediatric. Managing and mentoring Project Leaders in the US and Argentina.
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.
2003
Associate Director for a large CRO developing online training program for new Clinical Research Associates.
EMBRACE THE OPPORTUNITIESFOR PERSONAL AND PROFESSIONAL GROWTH
2015
Joined PAREXEL as a Human Resources Operations Partner.
2013
Human Resources Business Partner at leading pharmaceutical company.
1999
Manager of Diversity Resources.
1993
Assistant Manager for work/life balance programs.
1989
Associate Personnel Representative at leading consumer goods manufacturer.
BE PART OF A DIVERSE TEAMTHAT DRIVES HEALTHCARE INNOVATION
2017
Promoted to Director IT Project and Programme Office, where I am leading engineering projects for Wearable and Sensor Devices, with an 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.
2005
Senior Project Manager at a video game developer.
1997
Development Manager working on maternity ultrasound software.
1994
Lead Developer on software team.
OWN THE CHALLENGESTHAT MAKE YOU GROW
2017
Began a new role working remotely. As Medical Writer II, Scientific and Medical Services, I research, create, edit, and coordinate the development of independent review charters (IRC), reviewer manuals, imaging case report forms (CRFs), and other 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.
2001
Physical Therapy Rehabilitation Aide.
FORGE THE RELATIONSHIPSTHAT ELEVATE CUSTOMER EXPERIENCE
2016
Senior Director of Business Development at PAREXEL.
2003
Associate in the Proposal Development department at PAREXEL.
2000
Founder and Marketing Director of an IT venture company developing web related systems.
1999
Managed the Therapy Development Group at a leading health care products manufacturer.
1995
Relocated to the United States to pursue an MBA in Marketing.
OWN THE CHALLENGES THATLEAD TO INNOVATION AND GROWTH
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 the Latin America region.
2008
Associate Director of Clinical Management leading the implementation of a study start-up model in Latin America for a major CRO.
Natalia's leap forward came after joining the world of Clinical Research, where she progressed to the level of Clinical Operations Manager. In addition, Natalia took on responsibility for Site Start Up, extending her reach beyond Argentina to the whole of Latin America.
2000
Biochemist for a hematology lab.
1997
Team member connecting at-risk populations with primary healthcare and nutrition.
Leslie - Vice President of Integrated Product Development
Ruben – Associate Director in Project Management
Deborah – Human Resources Operations Partner
Martin – Associate Director of IT Program and Project Management
Nicholas – Medical Writer II, Scientific and Medical Services
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
Level: Mid
Travel: Yes
Success Profile
What makes a successful Consultant at PAREXEL? Check out the top traits we're looking for and see if you have the right mix.
Detail-oriented
10
Proactive
10
Relationship expertise
10
Problem-solver
9
Results-driven
9
Time Management
9
Communicator
8
Independent
8
Multi-tasker
8
"They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."
Jasen - Consultant
"My experience so far with PAREXEL has been great! I had initially started at PAREXEL as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."
Aqip – Consultant
"I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. PAREXEL is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."
Blaine – Consultant
"PAREXEL is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), PAREXEL offers a variety of rewards to the employees (bonus scheme, benefits etc)."
Giannis – Consultant
"PAREXEL is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."
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
CMC Consultant:
A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PAREXEL Consulting provides. A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.
Qualifications
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
Several years of experience in an industry-related environment
Variation/Lifecycle Maintenance experience EU/RoW: Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc.
Change Control assessment experience
Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME
Proficiency in local language and extensive working knowledge of the English language
