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Submission, Regulatory Operations, or Publishing Manager (West Coast)

USA - West - Home Based Date posted 06/06/2019 Job ID 52446BR

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

Amazing Opportunity to bring your regulatory submissions expertise to Parexel's Regulatory Outsourcing Services (PROS) Team as a Submission Manager/Senior Consultant!

In this highly visible role you will have a direct impact on our delivering on-time, quality applications for our clients. As a Submission Manager/Senior Consultant you will typically manage 1-2 long term client engagements; you will gain tremendous exposure as you oversee a variety of applications for various Health Authorities, and you will fully utilize your past technical publishing expertise and project planning experience to serve as a trusted advisor and partner to our clients.

As a Submission Manager/Senior Consultant, you will be responsible for planning, coordinating, compiling and submitting regulatory applications to regulatory affiliates worldwide, in accordance with current global regulatory submission standards. You will ensure the successful submission of dossiers in global Health Authority compliant format including eCTD, NeeS and paper. The Submission Manager liaise with our clients to ensure the completion of a submission planner that is aligned with the overall regulatory strategy and lead the publishing team to successfully publish the submission. This role interacts closely with both client and internal teams to drive the end-to-end regulatory submission publishing process.

To ensure success, you will need:

• Experience leading projects involving the assembly, formatting, publishing and submission of regulatory documents. This encompasses all project management activities including planning, coordination, and execution of high quality regulatory submissions of original applications (i.e. NDAs, MAAs, INDs) and any subsequent amendments, supplements and variations.
• The ability to work with a global team to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status balancing the quality, timeliness of client deliverables.
• Subject matter expertise regulatory submission formats, industry standards and the ability to interpret and apply regulatory guidance documents.
• Experience with eDMS and eCTD publishing software and other Regulatory Information management systems.

Qualifications

A minimum of a Bachelor's degree is required. Coupled with extensive experience in an industry-related role which includes 10+ years of regulatory operations experience, hands-on experience with publishing and RIM software

High-level consulting skills
 Critical thinking and problem-solving skills
 Project management knowledge including financial acumen
 Excellent interpersonal and intercultural communication skills, both written and verbal
 Client-focused approach to work
 Results orientation
 Teamwork and collaboration skills

Up to 30% travel required

Interested applicants who do not live on the West Coast in PST, must be willing to work a schedule to accommodate Parexel's West Coast clients ie. 11a-8pm EST or 12p-8pm EST for those interested applicants on the East Coast.

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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