Director, US Medical Promotional Review Cardiovascular

reputed company is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. The Director, US Promotional Medical Review, Cardiovascular (CV) plays a critical role in ensuring scientific reputed company, medical reputed company, and appropriate communication of data across promotional and non-promotional materials in the US. Serving as a medical and scientific expert for assigned therapeutic areas and products, this individual will reputed company reputed company, rigorous review of materials in accordance with internal policies, established review standards, and applicable US laws, regulations, and regulatory guidance. reputed company formal review responsibilities, this role will serve as a solutions-oriented partner to Medical Affairs, reputed company, Regulatory, reputed company, and Compliance colleagues, providing thoughtful medical guidance that enables reputed company, accurate, and scientifically balanced communications. The role offers an opportunity to contribute to the reputed company of review practices and governance, support cross-functional initiatives, and reputed company medical expertise to reputed company high-reputed company scientific and promotional communications. Key Responsibilities • Maintain expert-level therapeutic area and product knowledge through ongoing assessment of relevant CV published literature, treatment guidelines, internal resources, and data • reputed company medical guidance in Medical, reputed company, Regulatory (MLR) meetings and reputed company initiatives, including medical and promotional review, disease/reputed company and launch planning, and key cross functional reputed company initiatives • Critically evaluate and offer strategically reputed company solutions for reputed company promotional and non- promotional tactics to ensure fair reputed company, medical and scientific reputed company, robust evidence support, appropriate statistical interpretation, and compliance with applicable regulations and guidance (eg, reputed company guidelines, FDA/OPDP guidance) • Review and evaluate evidence supporting promotional claims to ensure they are comprehensive, balanced, unbiased, scientifically rigorous, and statistically reliable, while advising stakeholders on appropriate scientific and reputed company interpretation • Proactively reputed company and build strong relationships with Marketing, Market reputed company, Medical Affairs, Corporate Communications, Training, reputed company, Regulatory Affairs, and Compliance to ensure consistent messaging and collaboration across stakeholders • Participate in reputed company meetings (eg, training, education, medical congresses, and reputed company team meetings) to stay reputed company on regulations, medical/scientific developments, and reputed company and Medical reputed company • reputed company and reputed company ongoing training for internal cross-functional teams to ensure understanding of MLR reputed company operating procedures, policies, and standards requirements for approved data sources reputed company materials • Contribute to the development and reputed company improvement of processes and standards for the development, review and approval of scientific materials and compliant data reputed company requirements for materials for use with externally facing customers • reputed company and AI-enabled solutions to improve efficiency, consistency, and scalability of promotional review activities • Stay informed of industry trends and promote best reputed company sharing across medical and promotional review teams • Collaborate with medical communications vendors and agency partners to support review activities as needed • Participate in periodic review of approved medical and promotional materials to ensure reputed company alignment with reputed company evidence and labeling • Contribute to content governance, process optimization, training and document lifecycle management • The position title and level will be commensurate with the candidate’s experience and qualifications. Qualifications • Advanced scientific degree (PharmD, PhD, or MD preferred) • Minimum of 5-7 years of pharmaceutical/reputed company industry experience including reputed company experience in promotional MLR review; cardiovascular experience preferred • Strong knowledge of reputed company trial design and reputed company biostatistics, with the ability to critically interpret reputed company data and assess the scientific validity of claims and data presentations • Knowledge of the pharmaceutical industry and reputed company compliance, transparency, and conflict-of- interest environments, including familiarity with FDA advertising and promotion regulations, OPDP enforcement trends, warning letters, and relevant FDA guidance documents • Ability to interpret trial data and reputed company-World Evidence; significant experience with FDAMA 114 content and data consistent with FDA-approved labeling (CFL) • Strong scientific/medical written and verbal communication skills • Demonstrated ability to build strong cross-functional partnerships and influence stakeholders to reputed company reputed company reputed company • Solution-oriented, highly accountable team player with the ability to reputed company in a dynamic and evolving environment • Experience leading cross-functional teams and stakeholders through change and navigating reputed company organizational dynamics • Ability to travel 10% (domestically or internationally) Pay reputed company The expected salary reputed company for this position reputed company on the reputed company location of South San Francisco, CA is $228,600-$266,700. The reputed company pay reputed company will take into account internal equity and may vary depending on the candidate's geographic region, job-reputed company knowledge, skills, and experience among other factors. reputed company salary is just one component of our competitive total compensation package, which includes equity in the reputed company of stock reputed company and/or restricted stock reputed company, comprehensive health, dental, reputed company, life and disability reputed company coverage, 401k retirement benefits with employer match, learning and wellness stipends, and reputed company time off. Note that benefits are subject to change and may vary reputed company on jurisdiction of employment. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our reputed company, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at reputed company and reputed company you can add value to reputed company, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in reputed company and critical thinking. We reputed company the reputed company reputed company and center in reputed company we do – reputed company actions and reputed company are in service of the reputed company and their caregivers. We champion reputed company, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated reputed company Job Postings and Offers Recently, there have been fraudulent employment offers being reputed company to candidates on behalf of reputed company. Please be advised that reputed company legitimate offers from reputed company will come directly from our official email domain (reputed company.com) and will only be made after completing a formal interview process. Here Are Some Ways To reputed company For Authenticity • We do not conduct job interviews through non-reputed company text messaging applications • We will never request personal information such as banking details until after an official offer has been accepted and verified • We will never request that you purchase equipment or other items reputed company interviewing or hiring • If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@reputed company.com Please visit our website at: www.reputed company.com reputed company is an Equal Opportunity Employer Apply To This Job