Davita Inc. is hiring: Associate Director, Regulatory Advertising & Promotion Po

* Provide Regulatory advice to Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the review and development of advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy* Knowledge of FDA regulations governing the promotion of assigned products* Competitively position promotional materials that comply with applicable FDA regulations, policies and guidance* Interactions with OPDP/APLB, including supporting responses to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments* Assist on the development of US labeling to ensure support for anticipated promotional messages and claims* Understanding of labeling for assigned GSK and competitor products* Participate in company working groups on advertising and promotion standards and guidelines* Monitor OPDP/APLB research, guidance and enforcement activities, assess impact and communicate learnings to stakeholders* Member of multiple cross-functional US Pharma, Regulatory Matrix Team, and R&D teams Capabilities* Strong communication skills, both written and verbal* Demonstrated ability to excel in cross functional settings and to manage multiple projects in a fast-paced environment* Understanding of drug development, including clinical trial design and labeling development* Proficient in digital fluency capabilities to enhance project delivery and drive efficiency and innovationWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor Degree3 or more years of regulatory experience in the development of Pharmaceutical advertising and promotion for the US market (for major company assets)Prior work experience interacting with OPDP and/or APLB reviewersExperience working on pre-launch activities and launch promotional campaignsExperience facilitating groups of individuals to work together on creating solutionsPreferred Qualifications:If you have the following characteristics, it would be a plus:Advanced degree in biological or health care scientific discipline5 or more years of regulatory experience working on multiple products across a range of therapeutic areasExperience providing regulatory ad/promo consultations on target medicine profile, clinical trial designs and during labeling developmentAbility to manage and execute on projects independently, with minimal supervisionAwareness/familiarity working with the digitalization in development and regulatory strategy to enhance decision-making, and drive efficiency and innovationExcellent communication skills, both written and verbalPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

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