TrentonRecruiter Since 2001
the smart solution for Trenton jobs

Global Labeling Lead

Company: Unicon Pharma
Location: Trenton
Posted on: October 17, 2020

Job Description:

Location: Princeton, NJ Duration: Direct Placement Description: Summary 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. 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. This may also include Regulatory Authority driven documents such as the Core Safety Profile. 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 Specialists so that labeling and decision documents can be prepared and managed appropriately throughout Pharmaceutical processes and systems. The GLL also interfaces with Hub Labeling Managers and PCO colleagues to support timely and quality submissions globally. Qualifications Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as PhD an advantage but not essential.

Keywords: Unicon Pharma, Trenton , Global Labeling Lead, Other , Trenton, New Jersey

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


Choose your own schedule earn pay plus tips
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you 38 (more...)
Company: Shipt
Location: Westport
Posted on: 10/21/2020

Get New Installing/Repairing Window Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Westport
Posted on: 10/21/2020

Deliver Food with Uber - Flexible Gig
Description: Deliver with Uber. Earn on your schedule. 10 Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekendsit 38 039 s up to you. 10 Earn Good Money. Youll earn by (more...)
Company: Uber Eats
Location: Westport
Posted on: 10/21/2020


Get New Roofing Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Westport
Posted on: 10/21/2020

Class A Driver Jobs
Description: LIMITED TIME U.S. Xpress is offering NEW dedicated opportunity
Company: U.S. Xpress
Location: Westport
Posted on: 10/21/2020

Earn cash this Fall. Deliver with Uber!
Description: Deliver with Uber. Earn on your schedule. 10 Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekendsit 38 039 s up to you. 10 Earn Good Money. Youll earn by (more...)
Company: Uber Eats
Location: Westport
Posted on: 10/21/2020

Get New Remodeling Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Westport
Posted on: 10/21/2020

Part Time Driver
Description: DATTCO currently has a part-time School Bus Driver opening at our Westport, CT location.No experience No worries We will train you.What We Offer:
Company: Dattco
Location: Westport
Posted on: 10/21/2020

Truck Driver - Class A CDL - Dedicated
Description: LIMITED TIME U.S. Xpress is offering NEW dedicated opportunity
Company: U.S. Xpress
Location: Westport
Posted on: 10/21/2020

Caregiver / Companion
Description: Care In Homes is actively hiring caregivers, of ALL skill levels, to fill immediate needs for In Home Care Services. In Home Caregiver / Companion
Company: CareInHomes
Location: Westport
Posted on: 10/21/2020

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds