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Consultant - Labeling

USA - Any Region - Home Based Date posted 07/15/2019 Job ID 53394BR

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

INCREDIBLE HOME-BASED OPPORTUNITY DEDICATED TO ONE CLIENT!

If you passionate about labeling, have a passion for Regulatory Affairs, and are looking for an opportunity to say good-bye to sitting in traffic and wasting time with a daily commute, then Parexel's Consulting has an amazing opportunity for you!

Parexel’s Consulting Team is expanding, and we are seeking a Consultant, Regulatory Labeling to partner with our global client on US related labeling activities!

As a Consultant, Regulatory Labeling, you will:
  • Collaborate with the client and their partners on an effective and efficient process for the global distribution and tracking of labeling updates for products
  • Disseminate and track approved labeling documents and supporting documentation for labeling compliance distribution and implementation requirements
  • Team with Senior Consultant and/or Labeling Strategist to:
    • Conduct international labeling operations activities to support global new product and supplemental applications from product registration, through post approval launches for impacted international markets
    • Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control
  • Populate and maintain labeling systems; follows FDA postings e.g., DailyMed, Drugs@FDA
  • Execute quality control reviews and track (primarily) internal labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (USPI, Med Guide, EU SmPC, PIL, Canadian Product Monograph, Instructions for Use) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
  • Support SPL generation, including drug listing and establishment registration activities.
  • Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/ editing skills and compiling supportive documentation
  • Support labeling inspection/audit readiness activities
  • Serve as a Global Regulatory Affairs contact for PSMF activities
  • Collaborate with the Global Labeling Team to review and monitor safety variation tracking compliance metrics for CCDS related Safety Changes

Additionally, as a member of the Parexel Consulting team you will be able to successfully complete the following:

Qualifications

Project Execution
•Works effectively within a team environment
•Work within broad project guidelines as directed by the project Technical Lead
•With the guidance of the project Technical Lead, demonstrate the ability to prioritize work to achieve specified project outcomes
•Capitalize on opportunities to improve one’s own performance and seek feedback from the project Team Lead and colleagues
•Apply information provided by the project Team Lead or senior colleagues to complete assigned project activities
•Produce quality work that meets the expectations of project Team Lead and the client
Consulting Activities and Relationship Management
•Follow the organization’s consulting models and methodologies under the guidance of the Project Technical Lead
•Deliver a limited range of consulting services within personal area of expertise under the guidance of the Project Technical Lead
•Complete assigned activities within project scope and objectives under the direction of the Project Technical Lead
•Identify project and internal issues to senior colleagues and Project Technical Lead
•Interact professionally at all working levels within a client organization and within Parexel
•Identify project and/or client needs to the Project Technical Lead

Business Development
•Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)
•Communicate potential new business lead to PC management and account managers

Parexel-Related Responsibilities
•Meet established metrics as specified in scorecard on an annual basis
•Complete basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
•Define self-development activities with the support of management to keep current within the industry

Required Competencies
Client Focus (Quality), Results Orientation, Interpersonal Communication, Teamwork & Collaboration, Critical Thing, and Solving Business Problems
At least fluent vocal and written English

Minimum Work Experience
Bachelor’s Degree plus at least 5 years of experience in drug development in a labeling focused role to include a solid understanding of US labeling regulatory requirements, the requirements for tracking of labeling updates, the structure of the product labeling, the detail required to proofread labeling related documents, etc.

This is a home-based role; however, @ 30% domestic / international travel may be required to client offices coupled with flexibility to travel to Parexel's offices for team/client

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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