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Regulatory Consultant - Regulatory Submissions Publisher / Manager

USA - Any Region - Home Based Date posted 10/07/2019 Job ID 55608BR

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

Are you an experienced Regulatory Publisher who is looking to combine your publishing expertise with your passion for delivering on time quality submissions? Who is looking for an opportunity work from home? Who has superior interpersonal skills and enjoys establishing and maintaining internal and external relationship? And also is looking for an opportunity work alongside some of the Industry’s best? If you answered ‘yes’ to these questions, Parexel Consulting's growing Team has an excellent opportunity for you!

We currently have an amazing opportunity to join Parexel’s Regulatory Consulting Team as a Regulatory Publishing Consultant. A Regulatory Publishing Consultant must have strong technical publishing skills for regulatory knowledge and electronic submission skills in the eCTD format and may be developing specialist knowledge of a particular subject and/ or market. Additionally, a Regulatory Publishing Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead or Work Stream Lead, he/she assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations; functions as the main client contact and ensures accurate project reporting is in place; ensures that appropriate risk identification and issue-escalation procedures are in place; ensures project specific training compliance of the project team; ensures and/or manages project financials including provision of accurate revenue forecast; ensures that the project team understand and work to the scope of the contract; identifies new opportunities through Change In Scope or add-on business from existing work; and ensures timely project close-out activities are completed.

Qualifications

To ensure success, you will have:

•Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline is required, Advanced Degree Preferred
•5+ years of regulatory publishing experience with strong eCTD experience
• Previous experience with electronic publishing software (previous InSight Publisher experience is a plus, but not required)
•Previous experience with US and Canadian Health Authority Submissions is required. European and ROW Heath Authority experience is a plus!
•Demonstrated industry related project management experience and past experience overseeing a global team to achieve quality project deliverables within specified timelines
•Excellent interpersonal and intercultural communication skills, both written and verbal
•Client-focused approach to work (Quality)
•Results orientation
•Teamwork and collaboration skills
•Consulting skills
•Critical thinking and problem-solving skills
•Proficiency in local language and extensive working knowledge of the English language
•The ability to travel domestically and internationally up to 30% may be required

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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