LABELING STRATEGIST
TAMPA, FL

Hybrid role. 50% onsite, 50% remote.

Project Description:

• The Labeling Strategist on the US Labeling Operation Team (US Labeling Specialist) will be responsible for ensuring accuracy, consistency, and alignment of the Client's labeling with the FDA Regulations and the Client's Policy.
• Some key aspects of this role include document preparation for various FDA submissions, analyzing data, and reporting metrics.
• The US Labeling Specialist will manage critical stakeholder labeling communications and activities, ensuring timely and accurate implementation of product labeling for US launches and ongoing compliance requirements, recognizing that the US is a priority market for the Client.
• The US Labeling Specialist will ensure high quality and accuracy of all labeling for dissemination to wide and critical audiences by applying complex technical skills.
• Works under the guidance of the US Labeling Operations Senior Manager or with Senior Specialists.
• Manages external requests for data with professionalism and adherence to policy and regulations.
• Prepares and distributes US labeling submission documents that meet FDA and Client's internal standards (including annual reports, xml, and eCTD documentation).
• Manages the end-to-end labeling process to minimize the risk and associated costs to the Client and patients of a significant error occurring in final labeling preparations that results in a product delay or recall due to labeling.
• Approves and maintains artwork for US packaging components including decision when artwork should be printed "at risk.”
• Collaborates with contributing functional areas and external sources to verify accuracy of submission labeling components in the required formats.
• Advises Global Manufacturing and Supply of upcoming changes to labeling and provides guidance on when changes need to be implemented in the market.
• This responsibility encompasses safety and quality labeling compliance.
• Proactively identifies risks/issues and develops solutions to challenging areas related to assigned projects in the interest of keeping projects streamlined and moving forward.

Required Skills:

• Bachelor's or master's degree, preferred in sciences with more than 2 years of labeling experience in a regulated environment, or more than 3 years other pharmaceutical experience.
• Must possess an excellent command of English language.
• Good understanding of pharmaceutical or medical terminology.
• Good communication and organizational skills and a meticulous eye for detail.
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications as needed.
• Experience working on multi-disciplinary teams and projects.
• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g., revision control).
• The ability to work as part of a team with a high level of professionalism and discipline.
• Basic knowledge of FDA labeling regulations.
• US military experience will be considered towards industry experience requirements.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Milky: milky@alphaconsulting.com

ALPHA'S REQUIREMENT #23-00119
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Type: Contract

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Tampa, FL 33602: Reliably commute or planning to relocate before starting work (Required)

Experience:

• SQL: 5 years (Preferred)

Work Location: In person

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