Welcome to Simply Hired!

Like what you see here? Check out more Managers, All Other jobs like this one.

Show Me More

Director Regulatory Affairs Advertising and Promotion

Apply Now

Company: Sanofi Genzyme

Location: Cambridge, MA

Date Posted: January 27, 2015

Source: Sanofi Genzyme

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Job Title: Director, Regulatory Affairs, Advertising and Promotion

Job Responsibilities/Department Description:

The Director, Advertising and Promotion will be responsible for directing ...
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Job Title: Director, Regulatory Affairs, Advertising and Promotion

Job Responsibilities/Department Description:

The Director, Advertising and Promotion will be responsible for directing the regulatory aspects of review and approval of promotional materials and marketing activities for applicable Genzyme products and/or acquisitions. They are also responsible for providing regulatory leadership to the respective team charged with advertising and promotion review to ensure compliance of promotional materials and communications with FDA regulations and company policies. The Director will also deliver Regulatory compliance training to assigned team in preparation for scientific conferences. You will be responsible for participating in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials.

This position will serve as the primary contact leading and facilitating communications with the Office of Prescription Drug Promotion (OPDP) and direct the timely submission of all applicable approved promotional materials to the FDA on Form 2253. The candidate will manage the maintenance of records and databases that support communication with OPDP.

Qualifications
Basic Qualifications:Bachelors Degree and 7-10 years industry regulatory experience including knowledge and experience with advertising and promotional regulations. Experience communicating and negotiating directly with OPDP as well as proven experience practicing sound judgment as it relates to risk assessment.

Preferred Qualifications:
Master's Degree in a scientific discipline, PharmD, or JD
Must have strong leadership skills and be able to influence others and foster team collaboration.
#LI-GZ ~BSP

Job : Regulatory Affairs
Primary Location : United States-Massachusetts-Cambridge

Job Posting : May 21, 2014, 1:08:42 PM

Shift : Day Job
Job Type : Regular
Employee Status : Regular
,
,
,
,
,
Show more

Other jobs you might like

Show Me More