Job description
The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Title: Associate Director, US Regulatory Advertising & Promotional Labeling
The Company:
With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role:
Reporting to the VP, US Regulatory Advertising & Promotional Labeling, the Associate Director US Regulatory Advertising & Promotional Labeling will represent Regulatory in the review and approval of prelaunch and post launch promotional activities for U.S. marketed products. Contributes to the development and implementation of promotional review strategies. Maintains knowledge of applicable laws and guidance for prescription drug promotion.
Builds and maintains relationships with cross functional representatives of the Promotional Material Review Committee (PMRC) to ensure effective communication & efficient review of promotional activities. Assist in identifying areas of promotional risk and mitigation strategies. Serves as Regulatory representative in the Medical Review Committee (MRC) in the review and approval of compliant scientific materials.
Responsibilities:
- Provides regulatory advice for the development and approval of compliant advertising and promotional materials and activities for launch, marketed and development products, disease state education, field training, and other external communications.
- Provides strategic input, as well as preparation and execution of branded promotional material submissions to the Office of Prescription Drug Promotion (OPDP) that are compliant with applicable laws and regulations, as required.
- Develop working relationships with OPDP staff as necessary pertaining to the promotion of products especially those subject to accelerated approval requirements.
- Maintains a thorough understanding of OPDP requirements as well as knowledge of enforcement trends and provides analysis to review teams.
- Contributes to the development or modification of Regulatory advertising and promotion policies/procedures that affect immediate operations and may also have company-wide effect.
- Ensures documentation management and record keeping are compliant with regulatory expectations and Nuvalent SOPs
- Maintains knowledge of relevant evolving regulation and FDA guidance.
- Conducts periodic training on topics related to the regulation of prescription drug promotion.
Competencies Include:
- Excellent interpersonal, collaboration, written, verbal and visual communication skills.
- Motivated and curious learner with the ability to innovate, analyze, and solve problems,
- Ability to anticipate and identify regulatory risks and make recommendations as appropriate.
- Possesses a high degree of professional ethics, integrity, and responsibility.
- Exhibits flexibility and is adaptable to change in a fast-paced environment.
- Collaborate effectively with cross-functional colleagues at all levels including Medical, Legal and Commercial partners.
- The ability to multitask, prioritize, and work under pressure in adhering to deadlines.
- Proven ability to successfully manage projects and timelines, organize/track complex information.
Qualifications:
- BS or equivalent and at least 10 years of related experience
- Proficient in Advertising, Promotion and Labeling regulations, guidance, and OPDP expectations
- Experienced in providing regulatory input and evaluation as part of a promotional review committee.
- Experience with Accelerated Approval requirements in managing advertising and promotional material, subpart H pre-submissions and 2253 submissions.
- Experienced with Veeva Promo Mats and other electronic review systems.
- Expertise working with accelerated approval products, oncology and US commercial launch experience is a plus.
Additional Information:
Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.
The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change.
Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.
Annual Salary Range
$175,000—$205,000 USD
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from “@nuvalent.com” email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
