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Vice President, Technical - Compliance SME - (Home-based)

Uxbridge, England, United Kingdom Date posted 01/17/2020 Job ID post-50024501

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 Rating 3.5

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
  • "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."

    Aqip – 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

Parexel’s Regulatory Consulting team is known for our unparalleled breadth and depth of expertise globally. Parexel Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world, and we are growing!

We currently have a home-based opening on our Regulatory Compliance & Risk Management Team for an Industry Thought Leader to join Parexel's Regulatory Consulting Team of experts as a Technical Vice President - Compliance.

We are seeking a Thought Leader with expertise in data integrity assessments and remediation; performance of mock audits of pharmaceutical manufacturers & Biotech companies, Sponsor/Monitors, Clinical Investigators, IRBs, and non-clinical laboratories; providing inspection readiness assistance to Sponsor/Monitors & pharmaceutical manufacturers; and providing support during Drug GMP inspections, Sponsor-Monitor inspections, Clinical Investigator, Bio-equivalence laboratories, IRBs and non-clinical laboratories.

This expertise will also include experience with:
• Data integrity assessments, evaluation and remediation activities.
• Mock Pre-Approval inspections and remediation of identified gaps.
• Gap Analysis of Quality Systems & remediation.
• Assisting clients with MHRA & Warning Letter responses and remediation of regulatory issues.
• Conducting mock Pre-approval inspections of both finished pharmaceutical and API manufacturers.
• Providing backroom support & preparing SMEs during MHRA inspections and providing clients with strategies
during MHRA inspections.

• Assisting clients with CRO preparation for MHRA GCP inspection.
• Experience training on GMPs and GCPs.
• Inspections involving MHRA’s Application Integrity Policy.

A Technical Vice President must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. A Technical VP must have a thorough understanding of the organization’s consulting models and methodologies, as well as, extensive knowledge of what services Parexel Consulting (PC) provides. A Technical VP provides a full range of consulting services and works within their personal area of expertise. A Technical VP provides mentoring and guidance to other PC employees and leads knowledge-centered activities within PC. A Technical VP participates in the development of new service offerings, consulting models and methodologies.

Qualifications

Education
  • Minimum of an advanced degree in a scientific or technical discipline or MBA, PhD preferred, or equivalent experience
  • A pertinent professional certification such as R.Ph., RAC, CHCC, CQA, CQE, etc desirable but not mandatory
Language Skills

At least fluent verbal and written English.

Minimum Work Experience
  • The ideal candidate will be a highly experienced, senior current MHRA official, or ex-MHRA official with successful post-MHRA leadership roles in GMP within a consultancy or in-house sponsor company environment.
  • Must have high name recognition within the GMP/regulatory domain, and experience in the MHRA that is in line with the job description.
  • Should have an advanced degree in a relevant technical/scientific or business domain.
    Ideal candidate will have 15+ years of relevant experience, with at least 5+ years of MHRA experience.
Travel

Domestic and International Travel will be required.

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