Description

Senior Manager, Global Regulatory Sciences, Advertising, Labeling & Promotion

Location: Cambridge, MA

Requisition Number: 452

How will your role help us transform hope into reality?

The Senior Manager, GRS, Advertising, Labeling, & Promotion will be responsible for the review and submission of creative and compliant advertising and promotion materials for our commercial oncology and hematology portfolio. They will work with management to review, provide strategic advice and complete FDA 2253 submissions of advertising & promotion materials, in accordance with the requirements of the US Food and Drug Administration (FDA) and other health authorities, as needed, company policy, and PhRMA guidelines, FTC guidelines and guidance documents.

What will you do?

• Serves as a regulatory advertising and promotion reviewer on the cross-functional Promotional Review Board (PRB) for promotional regulatory review of the company’s commercial programs.
• Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
• Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.
• Works closely with Head of Global Regulatory Sciences Advertising, Labeling & Promotion and Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
• Monitors and keeps organization up to date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).
• Build a strong relationship with internal customers, including Commercial, Legal and Medical.
• Ensure timely and accurate submission of promotional materials to OPDP on Form 2253.
• Participate in discussions of product labeling submissions.
• Works with management and PRB to ensure that changes in US prescribing information are reflected in current promotions and advertising materials.
• Handle other duties and/or special projects as assigned

What minimum qualifications do we require?

• BA/BS Degree required 
• Minimum of 2 years Regulatory promotional review and submissions experience

What additional qualifications will make you a stronger candidate?

• Experience providing strategic direction to interdisciplinary teams on promotional materials activities for marketed products and strong interest in FDA advertising and promotional practice regulations including guidance(s).
• Strong oral and written communication skills.
• Detail & deadline oriented; well organized.
• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

COVID-19 Vaccination Requirement

As a biotechnology organization, it is our responsibility to do everything we can to safeguard the health and safety of our workforce, our communities, and the patients we serve.  That is why, prior to their start date, new hires must provide confirmation that they are fully vaccinated against COVID-19, or be approved by Blueprint for an exemption for health reasons contraindicating the vaccines or sincerely held religious beliefs.  Accommodation requests for either of these reasons should be made to TotalRewards@blueprintmedicines.com.

Equity, Diversity, Inclusion and Affirmative Action

At Blueprint Medicines, we foster a culture of equity, diversity and inclusion.  A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We are also an E-Verify Employer.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA-Policy-Statement, the EEO Poster and its Supplement, as well as our Pay Transparency Statement. 

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, torapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for systemic mastocytosis, lung cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.