CrystalLakeRecruiter Since 2001
the smart solution for Crystal Lake jobs

Manager, Regulatory Affairs Strategic Labeling (Oncology)

Company: AbbVie
Location: Crystal Lake
Posted on: January 12, 2020

Job Description:

The Manager Labeling Regulatory Affairs Strategic Labeling, develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Leads discussions and educates team members concerning global consistency of labeling. Key Responsibilities: Leads teams on labeling decisions based on knowledge of processes and regulations. Educates others as to new labeling regulations regarding Company core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), Structured Product Labeling (SPL) , or Instructions for Use ( IFUs) Reviews and assesses data to settle whether accurate and reproducible. Works with clinical and safety teams to assure revised data is included as support documentation following approvals. Provides labeling input for Risk Management Plans, Regulatory Strategic & Tactical Plans (RSTPs) and safety documents Drives strategic labeling processes within teams success with other products. Makes recommendations to proactively optimize label language, including effective use of Target Product Label (TPL) and Development Core Data Sheets (DCDS) as applicable. Maintains accurate files of labeling change history and associated documents, including annotations to data sources Participates at team meetings, reviews materials, authors documents and meets timelines. Leads cross-functional teams to resolve labeling issues and address Ministry of Health (MOH) requests globally Works with safety groups on safety issues and leads discussion on safety related labeling changes. Makes decisions on own topics and those of direct reports based on experience with various products. Understands and supports regulatory implications of product profile. Works strategically with R&D, Global Medical Affairs and safety to maintain accurate safety profiles for assigned products Works with Labeling Operations to ensure quality documents are internally maintained or submitted to FDA Provides labeling support to Asset Development Team (ADTs) and affiliates including pre-approvals, renewals, and competitive analysis May indirectly handle work of other department members. Assists in training of new personnel and in the development of department processes/policies. Required Education: Bachelor's degree in Pharmacy, Biology, Chemistry, pharmacology or related subject Preferred Education: Bachelor's degree. Certifications a plus Required Experience: 6 years in Pharmaceutical, regulatory, R&D or industry related area. Experience in labeling or area that could link to labeling Ability to supervise projects and set daily priorities. Able to work in a complex and matrix environment Preferred Experience: 3 years in pharmaceutical or regulatory preferred. Minimum 3 years' experience in clinical or pharmaceutical preferred Cross-divisional team experience and working with cross-functional teams Strong problem solving with minimal guidance Note: Higher education may compensate for years of experience

Keywords: AbbVie, Crystal Lake , Manager, Regulatory Affairs Strategic Labeling (Oncology), Other , Crystal Lake, Illinois

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


Flatbed Lease Purchase Trucking Job
Description: Join Blair Logistics Lease Purchase Opportunities Available We know Flatbed Drivers Are Our Number One Asset Load Every Truck Everyday BENEFITS -Home every weekend - 3,000 referral bonus -70-78 of (more...)
Company: Blair Logistics
Location: Dekalb
Posted on: 01/21/2020

CDL-A Truck Driver - No Experience Required!
Description: CDL-A STUDENT TRUCK DRIVER JOBSRecent CDL-A Graduate No Experience RequiredNew CDL-A truck driver school graduates can get on the right path to a fulfilling career with student truck
Company: J&R Schugel Trucking
Location: Crystal Lake
Posted on: 01/21/2020

Senior Front-End Engineer
Description: Join Hired and find your dream job as a Senior Front-End Engineer at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. You'll (more...)
Company: Hired
Location: Hoffman Estates
Posted on: 01/21/2020


Flatbed Owner Operator CDL-A Driver - LEASE PURCHASE
Description: Join Blair Logistics Lease Purchase Opportunities Available We know Flatbed Drivers Are Our Number One Asset Load Every Truck Everyday BENEFITS -Home every weekend - 3,000 referral bonus -70-78 of (more...)
Company: Blair Logistics
Location: Hoffman Estates
Posted on: 01/21/2020

Senior Software Engineer
Description: Join Hired and find your dream job as a Senior Software Engineer at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. You'll (more...)
Company: Hired
Location: Hoffman Estates
Posted on: 01/21/2020

CDL A Truck Driver
Description: Get home every weekend We put our drivers FIRST Apply today for CDL-A Company Truck Driver Jobs Call 866-683-9610 to learn more We have weekly hometime Our pay is very competitive with good miles (more...)
Company: FirstExpress
Location: Hoffman Estates
Posted on: 01/21/2020

Student Jobs - Drive with Lyft - Make $1550 in your First Month, Guaranteed
Description: What is Lyft Lyft matches drivers with passengers who request rides through the Lyft smartphone app. Signing up to be a Lyft driver is the perfect opportunity for you to set your own schedule and be your (more...)
Company: Lyft
Location: Hoffman Estates
Posted on: 01/21/2020

CDL-A Owner Operator Truck Driver
Description: CDL-A OWNER OPERATOR TRUCK DRIVER JOBS Owner Operators: Build your business with an industry leader At USA Truck, CDL-A Owner Operator truck drivers can count on outstanding support, plenty of freight (more...)
Company: USA Truck
Location: Hoffman Estates
Posted on: 01/21/2020

Class A CDL Trucking Job - Lease Purchase
Description: Join Blair Logistics Lease Purchase Opportunities Available We know Flatbed Drivers Are Our Number One Asset Load Every Truck Everyday BENEFITS -Home every weekend - 3,000 referral bonus -70-78 of (more...)
Company: Blair Logistics
Location: Dekalb
Posted on: 01/21/2020

Flatbed Owner Operator CDL-A Driver - LEASE PURCHASE
Description: Join Blair Logistics Lease Purchase Opportunities Available We know Flatbed Drivers Are Our Number One Asset Load Every Truck Everyday BENEFITS -Home every weekend - 3,000 referral bonus -70-78 of (more...)
Company: Blair Logistics
Location: Dekalb
Posted on: 01/21/2020

Log In or Create An Account

Get the latest Illinois jobs by following @recnetIL on Twitter!

Crystal Lake RSS job feeds