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Regulatory Affairs Consultant (Clinical Writing)

United Kingdom - Any Region - Home Based Date posted 05/18/2022 Job ID 79939BR

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

We are currently looking for a number of Regulatory Clinical Writers on various levels, ideally with experience working in the vaccine/ biologics area. This position is open in various European locations - office or home- based.
This is a fantastic opportunity to partner with a key client in biopharma industry!

Key responsibilities:
  • Develop regulatory plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects
  • Collaborate with Global RA Clinical Lead and/or Regional RA Clinical lead to provide regulatory support for assigned projects
  • Communicate with Regulatory Operations on the planning of marketing applications, post-approval supplements and variations
  • Contribute to the development of and to the definition of the Clinical content requirements for strategies for timely approval of regulatory filings throughout the product life cycle
  • Authoring clinical sections of regulatory files, life cycle variations/supplements for all destinations, including - CTD Modules 2 & 5, - Responses to Questions raised by Regulatory Authorities on clinical, epidemiological, and safety matters - Briefing documents for regulatory consultations - pediatric investigation plan (PIP)/pediatric study plan (PSP)
  • Ensure the coordination with the departments involved in the writing/review process)
  • Prepare and coordinate the review and approval of submission-ready documents
  • Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
  • Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copy/editing check
  • Work collaboratively with Clinical Writing colleagues and SMEs to interpret and summarize complex data

Qualifications

Skills and Experience required for the role:
  • BA/BS in scientific or technical discipline or advanced degree
  • At least 3-5 years of bio-pharmaceutical regulatory /clinical writing experience
  • Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance
  • Experience preparing Clinical sections of INDs, CTAs, NDAs, BLAs, MAAs and supportive amendments and supplements (ICH Modules 2 and 5)
  • Strong problem solving and diplomacy skills
  • Exposure to regulatory requirements for vaccines/biologic product development is highly desired
  • Excellent project management skills
  • Fluent English

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