PRAHS

2017-42641

- | US-IL | US-IL-Chicago | US-Remote
1 week ago
Title
Sr. Manager, Global Labeling - Deerfield, IL

Overview

Do you want to watch clinical development change, or do you want to be the one to shape it?

 

Because we’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 13,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

 

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Senior Manager, Global Labeling, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

 

Still here? Good. Because if this is you, we’d really like to meet you.

Responsibilities

What will you be doing?

 

As a Senior Manager, Global Labeling, you will function as the regulatory expert for labeling on the global Regulatory Affairs (RA) Subteam to ensure that regulatory labeling requirements are met for new product submissions.  Additionally, he/she is responsible for the development and maintenance of Company Core Data Sheets (CCDS) across multiple therapeutic areas in line with international standards and guidelines.  The Manager will guide the development of submission labeling for new compounds through the RA subteam, including multiple key markets (US, EU, others in line with global Regulatory Strategy).  Prepare the CCDS for assigned compounds during the development/submission cycle, and maintain through product lifecycle.  Oversee label content on a global basis to ensure that messages consistently meet strategic and business objectives, with appropriate supporting data.  Manages communication plans for affiliates regarding CCDS changes and required actions based on Global Labeling Oversight Committee (GLOC) decisions.

 

  • Support the Global Regulatory Lead (GRL) and Global Development Team (GDT) on all labeling matters.
  • Develop and execute global labeling strategies in collaboration with the GRL and RA Subteam for multiple therapeutic areas.
  • Provide advice and counsel on regulatory standards for labeling during development and propose draft text for regulatory submissions.
  • Assimilate relevant clinical and scientific information and recommend concise labeling language to the GRL for inclusion in key product labels (US PI, EU SmPC, others as appropriate) and incorporate consistent information into the CCDS.
  • Author the new or revised CCDS for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotation and supporting documentation.
  • Analyze relevant competitor labeling to ensure products have the most competitive labeling possible; maintain awareness of recent in-class approvals.
  • Author and manage outgoing communications regarding significant labeling change and mandatory CCDS changes for assigned products consistent with GLOC decisions.
  • Maintain up-to-date information regarding global standards, initiatives by regulatory authorities related to the CCDS and labeling and assure that processes conform to regulatory requirements.
  • Provide labeling strategy and guidance to affiliate Regulatory, in collaboration with the RA Subteam.
  • Evaluate risks associated with CCDS content and implementation strategies, develop mitigation plans, and appropriately escalate issues to GL management and the GRL.
  • Establish and manage cross-functional relationships to ensure control and continuous improvement of global labeling programs to meet business needs and regulatory requirements.
  • Supports the Manager, US Labeling and serves as backup, as needed.
  • Participate in training affiliate regulatory on relevant labeling policies and procedures, as needed.

Qualifications

What do you need to have?

 

Education: 

BS/BA degree with 5 years in Regulatory or related area, 3 years experience in labeling (or similar skill set) within the pharmaceutical industry.

 

Skills:

  • Significant knowledge of global standards and regulations related to New Drug Applications, CCDS, and Product Labeling. 
  • Understanding of scientific principles and regulatory/quality systems relevant to drug development.
  • Demonstrated problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
  • Excellent oral and written communication skills.
  • Demonstrated project management, negotiation, and interpersonal skills.
  • Ability to work in a team environment but can function equally well independently.
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

 

 To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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