PURPOSE OF JOB:
Provide regulatory strategy and leadership to enable the business to meet its commercial needs in a compliant manner. Responsible for ensuring regulatory compliance
of all advertising and promotional materials. Develop, implement and provide training on creation, review/approval and dissemination of advertising and
promotional material and sales training materials. Provide regulatory review for promotional, corporate and other non-promotional materials to assess
compliance with applicable regulations, guidance documents and internal policies/best practices. Serve as the company's regulatory liaison to the FDA Office of Prescription Drug Promotion (OPDP) for respective product(s) and ensure materials are submitted to FDA in a timely manner.
MAJOR DUTIES AND RESPONSIBILITIES:
This position requires an ability to understand and evaluate all perspectives and provide clear regulatory guidance.
Primary responsibilities include the review and approval of promotional, corporate and other non-promotional materials for Intersect products and associated therapeutic areas.
Clearly articulate the regulatory promotional perspective and rationale at team meetings and provide training to cross-functional.
Responsible for the development, implementation and training for procedures related to the creation, review/approval and dissemination of advertising and promotional material and sales training materials.
Serve as the company's regulatory liaison to the FDA Office of Prescription Drug Promotion (OPDP) for respective product(s).
Ensure materials are submitted to FDA in a timely manner.
Responsible for reviewing and interpreting enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies/best practices and processes.
Other activities, as needed
BS in life sciences, engineering, or equivalent required.
Advanced degree (MS, MPH, PharmD, PhD, JD) preferred
10 years’ experience in regulatory affairs for pharmaceutical companies and/or medical device/biopharmaceutical industry.
5 years’ experience in advertising and promotional review.
Excellent verbal and written communication skills and interpersonal skills are required.
Must have in-depth knowledge of commercial regulatory requirements associated with Advertising and Promotion of prescription drug products and medical devices.
Must have in-depth knowledge of regulatory requirements associated with pre-approval communications (press-release, website, conferences, meetings, etc.) regarding drugs and medical devices Advertising and Promotion of prescription drug products and medical devices.
Must be capable of developing and implementing regulatory strategy and managing complex negotiations with Regulatory Authorities.
Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, enforcement which may impact the Company's promotional activities.
Work within the position will be recognized as a knowledgeable resource for commercial regulatory advice on promotional, corporate and other non-promotional initiatives in other departments.
Direct experience working with OPDP is preferred.
Highly proficient in Microsoft Word, Excel, Power Point, MS Project and Adobe Acrobat.
Must be detail oriented with well-developed organizational and analytical skills.
Must enjoy working in a fast-paced, small company environment with proven ability to be flexible and adaptable within a changing dynamic environment.
Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or
Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move
objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally
and all other sedentary criteria are met.
Visual, Acuity, and Working Conditions:
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal;
extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.