At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.
Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.
Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.
To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
Job Summary & General Accountabilities
The Associate Director/Director, Regulatory Affairs Ad Promo (AD/D-RAP) will serve as the Regulatory Lead on relevant projects and represents MorphoSys US, Inc. as the regulatory contact with relevant divisions of FDA, specifically the Office of Prescription Drug Promotion (OPDP). Also, this position will be responsible for the ad promo submissions, listings and related vendor management. This position reports to the VP, Head of Regulatory Affairs US and will be remote or located in our Boston, MA office.
- As a member of the US Review Committee team, the AD/D-RAP will be responsible for providing input and advice on the review of promotional materials for regulatory validity
- Critically review and recommend changes to promotional materials/activities to ensure balance of messages, accuracy and appropriateness of content in materials/activities and regulatory adequacy in accordance with relevant guidelines and regulations
- Proactively align and build strong relationships with key stakeholders including Commercial, Legal and Medical on issues or concerns and to provide regulatory advice to ensure materials are balanced and accurate
- Determine acceptability of data/references used to support promotional claims and provide expert guidance and effective negotiation leading to resolution for the approval of materials
- Ensure implementation of updates in the labeling and maintenance of the labeling documentation, drug listing and SPL. Prepares and submit the various listings required by FDA.
- Keep the organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidelines, relevant FDA enforcement action and general awareness of industry practices, including those of competitors) and laws, regulations and policies enforced by the regulatory authorities as they relate to labeling, advertising and promotion of pharmaceuticals
- Prepares and submit the ad promo submissions and manages the vendor for the preparation of the submission, ideally can publish minor submissions.
Job Qualifications, Experience & Skills
Health & Safety
- Bachelor’s degree required; Advanced degree (e.g. PharmD, MS, PhD) preferred
- 5+ years industry experience with at least 3 years focused on the regulatory review of advertising & promotion of prescription drug products
- Subject matter expert on FDA requirements for pharmaceutical product promotion, advertising and labeling
- Strong interpersonal skills and exceptional communication skills, both oral and written
- Developed business acumen and ability to impact and influence senior level and key internal stakeholders
- Innovative, analytical and problem-solving capabilities, anticipating and identifying regulatory risks and making recommendations to management for resolution, as appropriate
- Strong leadership and organizational skills with demonstrated success in driving optimal business results with strong detail orientation
- Knowledge of Regulatory requirements when marketing online (i.e. internet, social media and other tools is strongly preferred)
- Proven ability to analyze and interpret efficacy and safety data
- Ability to work effectively across functions
- Creative, flexible team player with strategic thinking capabilities
Full vaccination against COVID 19 is a requirement for this position.
Culture & Benefits
As a full-time employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more. We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program. Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success.
MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices. We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.