How will your role help us transform hope into reality?
As GRS Manager of Advertising, Labeling, & Promotion, you will review and submit compliant advertising materials for our commercial portfolio. Responsibilities include ensuring content meets promotional regulations (US and Ex-US), completing FDA 2253 submissions, and adhering to FDA and company policies.
What will you do?
- Serves as a regulatory advertising and promotion reviewer on cross-functional Promotional Review Boards (US PRB/MRB and iPRB/iMRB) for promotional regulatory review of the company’s commercial programs.
- Independently develops solutions to promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
- Identifies and provides input on development and improvement of policies, processes, and standards for promotional materials and related activities.
- Monitors and keeps organization up to date on regulatory promotional environment (e.g., the issuance of new regulations/guidance, relevant enforcement action, and general awareness of industry practices, including those of competitors).
- Build a strong relationship with internal customers, including Commercial, Corporate Affairs, Legal and Medical.
- Ensure timely and accurate submission of US promotional materials.
- Participate in discussions of product labeling submissions, as needed.
- Works to ensure that changes and updates in prescribing information are reflected in current promotional and advertising materials.
- Perform other responsibilities as assigned.
What minimum qualifications do we require?
- BA/BS Degree required.
- Candidate should have a minimum of 4 years of content/materials review or health authority submissions experience.
What additional qualifications will make you a stronger candidate?
- Familiarity with FDA prescription drug promotion laws, regulations, policies, guidelines, and enforcement trends.
- Experience in the Pharma or Biotech industry or equivalent
- Familiar with Veeva PromoMats or similar review system
- Demonstrated ability with complex problem solving
- Excellent oral and written communication skills.
- Experience providing strategic direction to interdisciplinary teams on multidisciplinary teams
- Strong interest in FDA advertising and promotional practice regulations including guidance(s).
- Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism
Why Blueprint?
At Blueprint Medicines, patients are our purpose. Their needs ignite our innovation, fuel our urgency and inspire us to go further - faster. We bet on bold people who want to grow, push boundaries and lead meaningful change. Here, you’ll do the most impactful work of your career - because our commitment to changing lives isn’t just what we do, it’s who we are.
Patients are waiting. Are you ready to make the leap?
Compensation and Benefits
The base salary hiring range for this position will be $125,000 -- $ 165,000.* Actual base salary offered for this position will be based on a number of job-related factors, including, but not limited to: experience (including skills and competencies), education, training and internal equity.
This position is also eligible for the following:
- Participation in annual bonus program based on Company and individual performance, subject to the standard terms and conditions of the program
- Inclusive total rewards offerings focused on employee choice and professional and personal well-being. These include: medical, dental and vision benefits; Modern Health mental health and coaching benefits; medical and dependent care FSAs; generous paid time off (typically includes one-week well-being shutdowns at mid-year and year-end); subsidized commuting or parking benefits; 401(k) with match; generous paid medical, parental and family leave programs; disability benefits and more.
*Based on reasonable estimate for this job at the time of posting; ranges are reviewed periodically and subject to change.
To apply, just scroll down and click on the “Apply Now” link.
Equal Employment Opportunity
At Blueprint Medicines, we foster an environment of fair treatment and full participation for all of our employees as we navigate complex challenges in pursuing our mission to improve the lives of patients. We celebrate our unique differences and varied career and life experiences so that we can sustain our diverse culture and ensure everyone feels accepted. We are committed to non-discrimination, equal employment opportunity, as well as an inclusive recruitment process. We consider all qualified applicants based on merit and without regard to race, color, sex, gender identity, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable federal or state law.
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 [email protected]. We are also an E-Verify Employer. For more information, please see our EEO Policy Statement, the E-Verify Participation Poster, the Right to Work Poster, and/or the EEO Know Your Rights Poster.
Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.
Top Skills
What We Do
Blueprint Medicines is a global precision therapy company that invents life-changing medicines. Applying an approach that is both precise and agile, we create therapies that selectively target the root cause of disease, 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, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we have brought our approved medicines to patients in the United States and Europe, and we are globally advancing multiple programs for mast cell disorders, including systemic mastocytosis and chronic urticaria, breast cancer and other solid tumors.
With patients at the center of our mission, we aim to make real the promise of precision medicine to improve and extend life for as many people as possible. We know that in order to make a difference in their lives, we must create an environment where our employees — also known as the Blue Crew — can do their best work. Our culture of transparency, curiosity, and diversity pushes us to lead with integrity, act courageously, and draw upon a wide range of backgrounds and perspectives to make decisions. Ideas come from everywhere, from the C-suite to new hires, and each day we commit to approach one another with respect and trust.
We care deeply about making a profound impact where it matters most. Learn more about who we are and explore our career opportunities at https://www.blueprintmedicines.com/careers/.
Read our community guidelines: https://www.blueprintmedicines.com/community-guidelines
