Associate Director, Regulatory Affairs (Advertising & Promotions)
Lantheus Medical Imaging, Inc. - North Billerica, MA

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Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents. For more than 55 years, Lantheus has been dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.

Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).

Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.

In this position, the ideal candidate will provide operational regulatory expertise and direction to our corporation’s commercial functions related to advertising and promotional materials. Responsibilities include:

Lead the Promotional Review Committee as key regulatory member. This committee includes Medical Affairs, Legal, and other internal functional organizations and is responsible for the review of all advertising and promotional materials.

Establish and maintain strong working relationships with cross functional team members and external business partners.

Possess strong working knowledge with respect to the requirements of Office of Prescription Drug Promotion (OPDP). Have the ability to effectively use this knowledge to aid in the preparation of promotional materials, new campaigns, launch strategies and the review and approval of these materials for commercial use, as well as apply this understanding to business situations requiring other external communications.

Evaluate and monitor the advertising and promotional environment to identify current interpretation of regulations by the authorities, evolving policy issues and relevant enforcement activities. Communicate these to the organization and apply these as needed to LMI advertising and promotion efforts.

Advise and consult with Marketing in the preparation of advertising and promotional materials to ensure they are compliant with current regulatory requirements.

Review advertising and promotional materials for compliance with Agency regulations. Make recommendations aimed at ensuring compliance.

Act as a resource and consultant with ex-U.S. LMI locations and/or external business partners to review advertising and promotional materials to be compliant with local LMI product labeling as well as laws and regulations within that country.

Make and execute challenging decisions based upon a strong understanding of the regulatory requirements as well as business goals, with an understanding of when to elevate decisions to executive leadership for further considerations. Must be solution driven.

Work closely with the Regulatory labeling group concerning changes to the product labeling and the impact on advertising and promotion materials.

Serve as the primary contact with Office of Prescription Drug Promotion (OPDP).

Submit promotional materials to OPDP in accordance with regulations, and collaborate on final versions.

Possess a current understanding of Lantheus product offerings and the industry to impart beneficial, operational regulatory advice to a range of internal functional partners including Medical Affairs, Sales and Marketing, Legal and Corporate Communications.

Maintain current knowledge of, and ensure all work activities are conducted in compliance with regulatory requirements and LMI policies and procedures.

Strong communication and presentation skills. Able to present to various levels in the organization and to influence decisions based on sound regulatory knowledge and an understanding of business goals.

The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards. Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

Requirements include a Bachelor’s degree with 7-10 year’s regulatory experience in a pharmaceutical environment, or equivalent. Non-routine travel based on business need.

Lantheus Medical Imaging, Inc. - 23 months ago - save job - block
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