Director, Regulatory Affairs Advertising/Promotion

2 weeks ago

Belmont, United States Mirum Pharmaceuticals Full time

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it's like to be a part of our team: www.mirumpharma.com.

POSTION SUMMARY

The Director, Regulatory Affairs Advertising/Promotion will provide leadership, insight, and clear direction on all advertising and promotional programs and tactics that are compliant with regulations, aligned with approved product registrations, and company policies throughout the product life cycle. The Director will partner with all Regulatory Affairs functions, Medical Affairs, Legal, Compliance, Commercial and International distributors and will serve as a key member of the Medical/Legal/Regulatory (MLR) Review Committee. This role will report to the Head of Commercial Regulatory Affairs & Labeling (Executive Director).

JOB FUNCTIONS/RESPONSIBILITIES

  • Responsible for providing regulatory advertising/promotion leadership for assigned programs of marketed and investigational products in US and international regions.
  • Conduct review and approval of advertising/promotional materials as the lead regulatory reviewer on the MLR Committee for US and international markets.
  • Serve as the primary regulatory liaison to FDA/CDER/OPDP.
  • Author regulatory submissions (Form 2253) and work closely with the publishing vendor to ensure timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
  • Represent Regulatory Advertising/Promotion at labeling meetings and provide informed strategic regulatory guidance, as appropriate.
  • Provide regulatory guidance on new promotional or disease awareness concepts and new campaigns that may be related to Mirum products.
  • Maintain a continued awareness and understanding of FDA and international (e.g., EU and ROW) Health Authority regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely advice to the team.
  • Serve as an expert resource for regulatory advertising/promotion advice across departments.
  • May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
  • Responsible for the development and implementation of regulatory advertising/promotional processes, as necessary.
  • Support as needed for product labeling activities.

QUALIFICATIONS

Education/Experience:

  • Bachelor's or advanced degree in a biological or life sciences or related scientific discipline (pharmacy or medicine); an advanced degree is desirable.
  • A minimum of 10 years of biopharmaceutical industry experience, with a minimum of 8 years of experience in the regulatory review of advertising/promotional materials for prescription drug and/or biologic products.
  • Experience representing Regulatory Affairs Advertising/Promotion on cross functional teams.
  • Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
  • Excellent communication skills both verbal and in writing.

Knowledge, Skills and Abilities:

  • Direct experience with FDA's Office of Prescription Drug Promotion (OPDP) submissions and strategies. Experience with international (e.g., EU and ROW) Health Authorities is desirable; demonstrated contact through a CRO is acceptable.
  • Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products, and experience in applying such requirements is required.
  • Experience with global rules and regulations regarding promotion of medical products is highly desirable.
  • Excellent verbal, written, negotiation, influence and interpersonal communication skills required.
  • Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions. Demonstrated ability to analyze and interpret efficacy and safety data is critical.
  • Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Must be self-directed and proactive.
  • Ability to engage multiple stakeholders to achieve the business objective, while building excellent working relationships.
  • Strong team player that has a customer service approach and is solution oriented.

Work Environment:

  • This is a high growth, fast paced organization. The ability to be productive and successful in such a work environment is critical.
  • Some travel required. Responsibilities may require a work schedule that may include working outside of "normal" work hours in order to meet business demands in a company with activities taking place around the globe.

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

#J-18808-Ljbffr

  • Head of CMC Regulatory Affairs Small Molecules

    4 weeks ago

    Belmont, United States Gilead Sciences, Inc Full time

    Head of CMC Regulatory Affairs Small Molecules United States - California - Foster City Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.Head of CMC Regulatory Affairs - Small Molecules KEY RESPONSIBILITIES The Head of CMC Regulatory Affairs -...

  • Assistant Director of Nursing

    4 weeks ago

    Belmont, United States Rolling Hills Full time

    Job DescriptionJob DescriptionJob Description:Rolling Hills is seeking an Assistant Director of Nursing for our skilled nursing facility. The ADON will work in conjunction with our DON to coordinate and manage the clinical services for nursing, assisting in the responsibility and coordination of nursing care services provided to all residents of the...

  • LICSW, Program Leader

    2 weeks ago

    Belmont, United States Mass General Brigham Full time

    LICSW, Program Leader-(3288007) Description SUMMARY: Under the direction of the Clinical Director, and in partnership with the Nursing Director and Medical Director, the Program Director oversees the clinical and administrative functions of the program and is particularly responsible for maintaining quality of care in intake and referral process,...

  • RN Supervisor, 32 Nights Oak St Middleborough

    2 weeks ago

    Belmont, United States Partners Healthcare System Full time

    For designated shift, facilitates optimal utilization of nursing staff. Provides administrative/clinical supervision and consultation; serves as resource in emergency situations; promotes problem-solving approach for the purpose of conflict resolution; collaborates with the Nursing Directors. Principal duties and responsibilities to include the...

  • Culinary Director/Executive Chef

    1 week ago

    Belmont, United States Vista Terrace of Belmont Full time

    Job DescriptionJob DescriptionBringing people together in unique ways to enliven and enrich lives What can you expect?Cogir Senior Living is hiring a talented and experienced Director of Culinary Experience (Executive Chef) in our beautiful retirement community Vista Terrace of Belmont.Our Director of Culinary Experience (Executive Chef) is responsible for...

  • Director of Sales

    3 weeks ago

    Belmont, United States Daniel Stowe Botanical Garden Full time

    Job DescriptionJob DescriptionDescription:Accountability: Director of Sales & Visitor Engagement reports to the Executive Director Supervises: The Director of Sales & Visitor Engagement directly oversees the operations of Retail Services Private Events, Marketing, Exhibits & Public Events. About: Daniel Stowe Botanical Garden inspires a love of nature and...

  • Business Development Director

    2 weeks ago

    Belmont, United States Avegant Full time

    About: Avegant is a well-funded, venture-backed technology company developing the next-generation of light field displays. We are pioneering innovative hardware and software solutions that will forever change how we learn, play, work and interact with each other. We’ve won multiple awards, our team is best in class, and we’re just getting...

  • Business Development Director

    4 weeks ago

    Belmont, United States avegant Full time

    About:Avegant is a well-funded, venture-backed technology company developing the next-generation of light field displays. We are pioneering innovative hardware and software solutions that will forever change how we learn, play, work and interact with each other. We’ve won multiple awards, our team is best in class, and we’re just getting started.Avegant...

  • Marketing Assistant

    6 hours ago

    Belmont, United States Vantage Concepts Full time

    Vantage Concepts is seeking a vibrant, energetic, and dedicated entry-level Marketing Assistant to join our growing team! Our firm has been in the Charlotte area and was founded on the principles of excellent customer service and a dedication to providing our clients with the highest quality of marketing, sales, and advertising services. Our goal is to...

  • Clinical Research Assistant II

    5 days ago

    Belmont, United States Partners Healthcare System Full time

    GENERAL SUMMARY/OVERVIEW: The McLean Behavioral Psychopharmacology Research Laboratory is seeking a full-time Clinical Research Assistant II (CRA-II) to work on several research studies involving substance abuse and drug development using magnetic resonance imaging (MRI), electroencephalographic (EEG) and other laboratory/outpatient procedures. Duties...

  • Marketing Assistant

    1 week ago

    Belmont, United States Vantage Concepts Full time

    Job DescriptionJob DescriptionVantage Concepts is seeking a vibrant, energetic, and dedicated entry-level Marketing Assistant to join our growing team! Our firm has been in the Charlotte area and was founded on the principles of excellent customer service and a dedication to providing our clients with the highest quality of marketing, sales, and advertising...

  • Marketing Assistant

    1 week ago

    Belmont, United States Vantage Concepts Full time

    Job DescriptionJob DescriptionVantage Concepts is seeking a vibrant, energetic, and dedicated entry-level Marketing Assistant to join our growing team! Our firm has been in the Charlotte area and was founded on the principles of excellent customer service and a dedication to providing our clients with the highest quality of marketing, sales, and advertising...

  • Senior Clinical Research Assistant

    2 weeks ago

    Belmont, United States Partners Healthcare System Full time

    GENERAL SUMMARY: Working independently under the Director of the Behavioral Psychopharmacology Research Laboratory, coordinates all activities of research area including but not limited to: supervising the daily activities of research assistants and support staff, implementing, and maintaining quality assurance procedures, performing statistical analyses,...

  • Registered Nurse

    1 week ago

    Belmont, United States Atrium Health Full time

    Overview This position is Sign-on Bonus eligible. Experienced RNs with a minimum of 1 year of experience are eligible for a bonus. In addition to the sign-on bonus, new teammates at Atrium Health are eligible for robust benefits packages, paid time off, and a Career Advancement Ladder.Job SummaryResponsible for the direct provision of patient care and for...

  • Registered Nurse

    4 weeks ago

    Belmont, United States Atrium Health Full time

    Overview This position is Sign-on Bonus eligible. Experienced RNs with a minimum of 1 year of experience are eligible for a bonus. In addition to the sign-on bonus, new teammates at Atrium Health are eligible for robust benefits packages, paid time off, and a Career Advancement Ladder. Job Summary Responsible for the direct provision of patient care and...

  • Registered Nurse

    2 days ago

    Belmont, United States Atrium Health Full time

    Overview This position is Sign-on Bonus eligible. Experienced RNs with a minimum of 1 year of experience are eligible for a bonus. In addition to the sign-on bonus, new teammates at Atrium Health are eligible for robust benefits packages, paid time off, and a Career Advancement Ladder. Job Summary Responsible for the direct provision of patient care and for...

  • Registered Nurse

    7 days ago

    BELMONT, United States Atrium Health Full time

    Overview This position is Sign-on Bonus eligible. Experienced RNs with a minimum of 1 year of experience are eligible for a bonus. In addition to the sign-on bonus, new teammates at Atrium Health are eligible for robust benefits packages, paid time off, and a Career Advancement Ladder. Job Summary Responsible for the direct provision of patient care and...

  • RN Supervisor, 32 Nights Oak St Middleborough

    2 hours ago

    Belmont, MA, United States Partners Healthcare System Full time

    For designated shift, facilitates optimal utilization of nursing staff. Provides administrative/clinical supervision and consultation; serves as resource in emergency situations; promotes problem-solving approach for the purpose of conflict resolution; collaborates with the Nursing Directors. Principal duties and responsibilities to include the...

  • Registered Nurse

    7 days ago

    Belmont, United States Atrium Health Full time

    OverviewThis position is Sign-on Bonus eligible. Experienced RNs with a minimum of 1 year of experience are eligible for a bonus. In addition to the sign-on bonus, new teammates at Atrium Health are eligible for robust benefits packages, paid time off, and a Career Advancement Ladder.Job SummaryResponsible for the direct provision of patient care and for...

  • Program Manager

    6 days ago

    Belmont, United States McLean Hospital(MCL) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Research Program Manager will develop programs, best practices and standard operating procedures to achieve assigned goals as related to research space support within the McLean Imaging Center (MIC).This role will work directly with research staff at all levels, hospital support service departments and external...