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Senior Regulatory Affairs Consultant - Clinical Writing (Vaccines)

USA - Any Region - Home Based Date posted 05/22/2022 Job ID 78911BR

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.

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

AMAZING OPPORTUNITY TO PARTNER WITH AN INNOATIVE, LARGE GLOBAL PHARMACEUTICAL COMPANY AND GROW PROFESSIONALLY.

If you love writing, have a passion for clinical regulatory strategy, have past experience with vaccines or a desire to learn more about these vital products, 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 Regulatory Affairs Consultant, you will:
Be responsible for Regulatory technical writing (clinically focused) to support development of clinical documents in accordance with ICH/E6/GCP guidelines to support US/EMA submissions, clinical trial applications, and clinical consultation responses.

Qualifications

Qualifications:
1) RA professional with 5-10 yrs experience in clinical development that includes writing of clinical technical documents and a strong understanding of ICH/E6/GCP guidelines.
2) Bachelor’s degree or PhD in science/biological or healthcare.
3) Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
4) Extensive experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
5) Extensive knowledge of being able to develop product/therapeutic knowledge in a new area.

This role may require <30% domestic and/or international travel in the future

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.

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