Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
Role Summary
Director, US Regulatory Affairs - Advertising and Promotion oversees regulatory strategy for advertising and promotion in the US, partnering with cross-functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. This is a subject matter expert role with no direct reports, though mentoring, training and team leadership opportunities exist. Location: Cambridge, MA; Morristown, NJ. Responsibilities
Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution. Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process. Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports. In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. Continually monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends and evaluates the impact on external environments and the business. Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy. Establishes and develops key internal relationships with therapeutic product leaders to foster open communication and teamwork. Assures alignment and consistency in policy application within and across therapeutic products; takes into account the totality of product-related and company activities. Assists in ensuring product support relationships with FDA are established and maintained. Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities. Qualifications
Required: Earned Bachelor’s degree from an accredited four-year college or university in a Life Sciences or other relevant discipline 8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data. Can build networks to obtain cooperation without relying on authority, including participating in cross-functional groups (medical, legal, regulatory, etc.) to lead toward decisions. Ability to generate innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities. Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans. Able to establish priorities and timelines to effectively self-manage workload. Is able to multitask exceptionally well. Deals with people in an honest and forthright manner representing information and data accurately.
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Director, US Regulatory Affairs - Advertising and Promotion oversees regulatory strategy for advertising and promotion in the US, partnering with cross-functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. This is a subject matter expert role with no direct reports, though mentoring, training and team leadership opportunities exist. Location: Cambridge, MA; Morristown, NJ. Responsibilities
Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution. Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process. Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports. In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. Continually monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends and evaluates the impact on external environments and the business. Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy. Establishes and develops key internal relationships with therapeutic product leaders to foster open communication and teamwork. Assures alignment and consistency in policy application within and across therapeutic products; takes into account the totality of product-related and company activities. Assists in ensuring product support relationships with FDA are established and maintained. Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities. Qualifications
Required: Earned Bachelor’s degree from an accredited four-year college or university in a Life Sciences or other relevant discipline 8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data. Can build networks to obtain cooperation without relying on authority, including participating in cross-functional groups (medical, legal, regulatory, etc.) to lead toward decisions. Ability to generate innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities. Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans. Able to establish priorities and timelines to effectively self-manage workload. Is able to multitask exceptionally well. Deals with people in an honest and forthright manner representing information and data accurately.
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