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Regulatory Affairs Consultant - Clinical Writing (UK)

Uxbridge, England, United Kingdom Date posted 09/14/2021 Job ID 71646BR

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

Overall Focus:-

* Authoring of Clinical Overviews (CTD Module 2.5) and Clinical Summaries (CTD Moldule 2.7);
* Preparing CTD modules 4 and 5;
* Authoring clinical sections of regulatory documentations (IMPD's), Scientific Advice Briefing Documents, Investigator Brochures, Pediatric Investigation Plans, Orphan Designation Applications, etc).

Qualifications

Education:-
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced degree preferred;

Essential Skills and Experience:-
Ability to summarize regulatory guidelines and apply them appropriately;
Ability to understand and interpret clinical data from different sources;
Experience authorising regulatory documents or writing in peer reviewed journals;
Several years of experience in an industry-related environment preferred;
Experience with safety reports (DSUR, PSUR) is a plus;
Critical thinking and problem-solving skills;
Time management;
Proficiency in local language and extensive working knowledge of the English language.

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