DurhamRecruiter Since 2001
the smart solution for Durham jobs

Global Labeling Lead - remote

Company: Covance
Location: Durham
Posted on: November 20, 2020

Job Description:

Job Description Job Overview: The Global Labeling Lead (GLL) has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. The GLL will guide and advise the Labeling Team on internal labeling guidances and policies and will raise awareness of important factors to consider when revising the label. The GLL will keep up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles. The GLL will also be knowledgeable on key labeling requirements worldwide, in order to ensure that CDS/CSI updates may be implemented globally. The GLL will review the downstream impact of CDS/CSI updates on Local Product Documents (LPD) and ensure that downstream impact on LPDs is considered during Labeling Team discussions. The GLL will advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text. The GLL provides project management to the Labeling Team throughout the entire process, from the decision to update a CDS/CSI/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that Labeling Teams are aware of the required timelines and following up with Labeling Team members throughout the process so that deliverables remain on target to meet internal and external deadlines. The GLL serves as the GLM primary point of contact for Labeling Teams (e.g. WRS Strategist, Functional Line SMEs, Labeling Justification Document/Clinical Overview author) and will provide day-to-day direction to Labeling Operations Managers so that labeling and decision documents can be prepared and managed appropriately throughout Pfizer processes and systems. The GLL also interfaces with Hub Labeling Managers and PCO colleagues to support timely and quality submissions globally. The GLL will support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals. Main Responsibilities: * Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures)and their associated Patient Labeling Documents. * Engage in and contribute to Labeling Team discussions around content and format of the above mentioned documents, as well as downstream impact on LPDs worldwide. * Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be transcribed into the LPDs worldwide. * Prioritize Labeling Team activities and set clear targets using project management tools. Follow up with Labeling Team members to secure their contributions so that internal and external deadlines are met. Identify and assist teams to overcome barriers in achieving quality and compliance. * Oversee and direct Labeling Operations Specialists. * Communicate label update plans to the Hub labeling Managers in a timely manner. * Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems. * Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate. * Champion continuous improvement of business practices associated with processes and tools through liaison with Hub Labeling Managers, Labeling Operations Specialists and Regulatory Strategists. * For deliverables in scope, support responses to inquiries from Client colleagues related to inspection activities and regulatory agency questions. #LI-Remote Education/Qualifications: BS in Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as PhD an advantage but not essential Experience: * Knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions. * Demonstrated knowledge and understanding of company Core Da

Keywords: Covance, Durham , Global Labeling Lead - remote, Other , Durham, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Car detailer (2nd shift)
Description: About CarvanaAt Carvana, we sell cars but we arent car salesmen. Our promise is simple: we wont sell a car to a customer that we wouldnt sell to our own Mom. Period. To make sure our cars are in first-rate (more...)
Company: Carvana
Location: Danville
Posted on: 11/30/2020

Stocking & Unloading
Description: Stocking, backroom, receiving associates
Company: Connexus
Location: Danville
Posted on: 11/30/2020

Food & Grocery
Description: Why is Walmart America's leading
Company: Connexus
Location: Wilson
Posted on: 11/30/2020


RN, LPN, CNA
Description: RN's, LPN's and CNA's Roman Eagle Rehabilitation amp Health Care Center has
Company: Recruitology, Inc.
Location: Danville
Posted on: 11/30/2020

Chiropractor
Description: FULL TIME Chiropractor Needed in Danville Virginia We are currently seeking a full-time Chiropractor DC to join a growing
Company: Healthcare Recruitment Counselors
Location: Danville
Posted on: 11/30/2020

Hair Stylist - Gateway Plaza
Description: Job Description: At Great Clips, we know that stylists like you are most happy when they're cutting hair, so at a Great Clips salon, that's exactly what you get to do Want to be the
Company: Great Clips
Location: Wilson
Posted on: 11/30/2020

Stocking & Unloading
Description: Stocking, backroom, receiving associates
Company: Connexus
Location: Wilson
Posted on: 11/30/2020

Auto Care Center
Description: Are you an ace with car maintenance
Company: Connexus
Location: Wilson
Posted on: 11/30/2020

Semi-Regional CDL A Truck Driver - $3,500 Sign On Bonus - Avg. $70k/yr (67099)
Description: Drive Your Future With CDL-A Semi-Regional Company Truck Driver Positions At Hub Group NOW OFFERING 3,500 SIGN-ON BONUS Get the miles that take your career further with Hub Group s Semi-Regional (more...)
Company: Hub Group Dedicated
Location: Danville
Posted on: 11/30/2020

Prepared Meals and Rotisserie Chicken Associate
Description: Be a Team Member: Maintains up-to
Company: Connexus
Location: Danville
Posted on: 11/30/2020

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Durham RSS job feeds