This Job Vacancy has Expired!

Associate Director, Regulatory Labeling Strategy

Posted on Dec 10, 2018 by Shire Pharmaceuticals

Cambridge, MA 02138
Senior Appointments
Immediate Start
Annual Salary
Full-Time
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Shire Human Genetic Therapies Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Associate Director, Regulatory Labeling Strategy

POSITION DESCRIPTION: Shire Human Genetic Therapies Inc. is seeking a Associate Director, Regulatory Labeling Strategy with the following duties: Provide labeling strategy by assessing global/local labeling regulations, competitor labeling, labeling trends, and company internal data to optimize the product labeling for the benefit of the patient; Author/review/update company core data sheet (CCDS), core safety information (CCSI), Reference Safety Information (RSI), documents and present to the Executive Labeling Committee (ELC) for approval; Prepare response document and backup strategy for label negotiations with Health Authorities to address the labeling-related queries by interpreting clinical and scientific data from Clinical study report, Safety summary, toxicology reports, Chemistry/manufacturing reports and other sources; Lead the Labeling Team to develop labeling content to include the safety signals and to align with the latest Risk Management Plan (RMP), Periodic Benefit Risk Evaluation Report (PBRER) outcomes; Manage all type of labeling document/components in the relevant electronic document management systems (such as First Doc, labeling tracking system, SharePoint) for regulatory compliance.

REQUIREMENTS: Bachelor s degree in a scientific discipline or closely related field (i.e. dental surgery, medicine) plus 8 years of related experience. Required skills: Provide labeling strategy by assessing global/local labeling regulations, competitor labeling, labeling trends, and company internal data to optimize the product labeling for the benefit of the patient (5 yrs); Author/review/update company core data sheet (CCDS), core safety information (CCSI), Reference Safety Information (RSI), documents and present to the Executive Labeling Committee (ELC) for approval (5 yrs); Prepare response document and backup strategy for label negotiations with Health Authorities to address the labeling-related queries by interpreting clinical and scientific data from Clinical study report, Safety summary, toxicology reports, Chemistry/manufacturing reports and other sources (5 yrs); Lead the Labeling Team to develop labeling content to include the safety signals and to align with the latest Risk Management Plan (RMP), Periodic Benefit Risk Evaluation Report (PBRER) outcomes (5 yrs); Manage all type of labeling document/components in the relevant electronic document management systems (such as First Doc, labeling tracking system, SharePoint) for regulatory compliance (5 yrs).

Full time. $139,800 - $209,700 /year. Competitive compensation and benefits.

Qualified applicants can apply directly to the Shire careers page at: Please reference job #R. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.

Associated topics: business, cmo, event, fundraise, hospital, medical center, product market, public, regulatory, stewardship

Reference: 599012755