Posted in Other about 6 hours ago.
Location: Thousand Oaks, California
Innova Solutions has a client that is immediately hiring foran
Mgr. Labeling
Position type: Full time Contract.
Duration: 6 months
Location:
Thousand Oaks, CA (Remote)
As an
Mgr. Labeling
, you will be:
Job Description:
As part of Global Labeling Strategy and Compliance (LSC), and under the supervision of the Therapeutic Area Lead, the Labeling Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre & post marketed products over the products life cycle. The Labeling Strategist, Manager will lead the development of the Core Labeling documents. and US Labeling deliverables in accordance with Client Labeling Processes for assigned therapeutic area(s).
Principal responsibilities include, but are not restricted to:
• Chairs/leads the Labeling Working Group (LWG), and presents to Executive Labeling Board the labeling documents review/governance
• Represents labeling on product-specific global regulatory teams
• Leads the development and maintenance of core labeling documents including Core Data Sheet(CDS), core patient information leaflet (CPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and Medication guide. Manages products with a medium to high degree of complexity from a labeling perspective.
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends impacting the LWG and across the regulatory organization.
• Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents
• Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans is aligned with global regulatory strategies
• Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are escalated appropriately.
• Contributor to strategic creation of target product labeling
• Assists in preparation of responses to labeling-related Health Authority queries including supporting Packaging Component Labeling
• Manages the review and approval of core DHCP letters
• Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews.
Preferred Qualifications:
• Degree in pharmaceuticals, natural science or medicine
• Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
• Knowledge of labeling within a Therapeutic Area
• Knowledge of FDA, or EMA, or other international regulations for labeling
• Understanding the impact of emerging trends and their implications for client
• Project Management experience, experience managing individual and group projects of moderate complexity
• Experience working in a Veeva/Documentum-based document management system
Basic Qualifications:
Doctorate degree
OR Masters degree and 2 years of related experience
OR Bachelors degree and 4 years of related experience
OR Associates degree and 10 years of related experience
OR High school diploma / GED and 12 years of related experience
Knowledge & Skills:
• Knowledge of global labeling regulatory requirements, standards and processes
• Understanding of product development is required, and a solid understanding of biology and pharmacology relevant to the therapeutic area
• Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Namrata Gautam
Senior Associate Recruitment
PHONE: (+1) 314-523-1818
EMAIL: Namrata.Gautam@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $47- $52 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
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