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
- 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
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Do you have a flair for Regulatory Writing?
If you love writing, have a passion for clinical and nonclinical regulatory strategy, have experience with biologics, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining tremendous professional experience and working with some of the Industry’s BEST, then Parexel's Regulatory Consulting team has an amazing opportunity for you!
As a Clinical/Nonclinical Regulatory Writer, you will:
Be responsible for Regulatory technical writing to support development of clinical documents in accordance with ICH/E6/GCP guidelines to support US submissions, clinical trial applications, and clinical consultation responses for multiple clients.
Qualifications:
RA professional with experience in clinical development that includes 4+ years experience writing clinical and nonclinical technical documents and a strong understanding of ICH/E6/GCP guidelines.
Primarily seeking an experienced Clinical author to support FDA submissions:
New INDs
Pediatric Plans, Fast Track Applications, Breakthrough Therapy Applications, Orphan Drug Applications, responses to FDA requests, Meeting Request and Packages
NDA/BLA submissions
Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
Extensive experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
Extensive knowledge of being able to develop product/therapeutic knowledge in a new area.
Previous experience independently authoring clinical and nonclinical modules for FDA submissions to include experience authoring 2.4, 2.5, 2.6, 2.6.2, 2.6.4, 2.6.6, 2.7, 2.7.3 and 2.7.4 is required. EU submissions experience is a plus.
Previous Biologics experience is required. Previous device experience is a plus.
Previous experience with oncology or rare disease products is a plus.
Bachelor’s, Master’s or PhD in science/biological or healthcare.
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