• Job Type:Contract

Posted 17 days ago

Job Description:

• The Labeling Strategist on the US Labeling Operation Team (US Labeling Specialist) will be responsible for ensuring accuracy, consistency, and alignment of labeling with the FDA Regulations and 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.

• 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 internal standards (including annual reports, xml and eCTD documentation).

• Manages the end-to-end labeling process to minimize the risk and associated costs to 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:

• 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 details.

• 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).

Ideal Candidates Would Also Have:

• The ability to work as part of a team with a high level of professionalism and discipline.

Other qualifications*:

• Basic knowledge of FDA labeling regulations.

• US military experience will be considered towards industry experience requirements.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613