Sr./Director, Advertising and Promotion – Regulatory Affairs

20 Mar, 2021

Jobs

Sr./Director, Advertising and Promotion – Regulatory Affairs

Moderna
Cambridge, MA

The Role:

Manage the review and approval of all US promotional materials and submission of such materials to FDA at time of dissemination and provide oversight of the review and submission of advertising and promotional materials for all company products marketed globally.

Here’s What You’ll Do:

Promotional Material/External Communications Responsibilities

  • Develop and maintain current knowledge of requirements for regulation of drug marketing and advertising and competitive landscape.

  • Communicate FDA requirements to relevant stakeholders involved in the preparation or review of external communication materials and be conversant with International Advertisement and Promotional regulations and policies.

  • Collaborate with originators and cross functional team in the development of new promotional initiatives/programs and review supporting materials ensuring compliance and consistency with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act.

  • Direct coordination of complex OPDP/APLB submissions in collaboration with Regulatory Affairs Labeling, Advertising and Promotion Manager

  • Direct the regulatory review of non-promotional scientific information, and external communication materials, including media information and provides proactive feedback.

  • As a member of the Promotion Review Team, review and approve US promotional materials for compliance with the letter and spirit of FDA regulations and our company’s policies and standards.

  • Review and approve promotional materials for submission to FDA in a timely manner and in accordance with FDA regulations.

  • Oversee global review of promotional materials conducted by ex-US partners for submission to International Health Agencies.

  • Develop and implement effective strategies for FDA promotional submissions.

  • Prepare submissions of press releases and promotional materials for FDA review and comment.

  • Maintain current awareness of evolving FDA and International regulations and interpretations, FDA advisory letters, enforcement letters, and policy issues affecting the biopharmaceutical and vaccine industry.

Management responsibilities

  • May provide leadership and guidance to labeling/promotion managers.

  • Interact with senior management, external departments and regulatory authorities as needed.

  • Participate in forecasting and planning activities for resources for the future needs for Regulatory Affairs.

Here’s What You’ll Bring to the Table:

  • Bachelor’s degree required; Advanced degree preferred

  • At least 12 years of relevant experience in the pharmaceutical industry with preferably 7 years in Regulatory Affairs and specific experience in advertising and promotion

  • Extended knowledge of US labeling and promotion regulations and guidance and working knowledge with International Ad/Promo regulations.

  • Extended knowledge of science and data of assigned products and how that translates into labeling language.

  • Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.

  • Experience of product launch preferred.

  • Demonstrated expertise in technology systems utilized for electronic documentation, including, but not limited to Microsoft Office, Adobe Acrobat, and Veeva.

  • Ad/Promo experience in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.

  • Integrity: overriding commitment to integrity and high standards in self and others.

  • Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence.

  • Strategic orientation: ability to link visions and daily work

  • Communication: ability and intend to effectively explain, describe or convey information to a variety of audiences.

  • Collaborate effectively as member of the Regulatory sub-team and collaborate with business partners, including affiliates and third parties.

  • Develops others: involved in a genuine intent to foster development of others; mentoring

  • Flexibility/adaptability: ability to adapt to, and work effectively within a variety of situations and with various individuals or groups.

  • Work collaboratively with the business to ensure that promotional practices are consistent with regulatory guidelines and support business objectives.

Here’s What We’ll Bring to the Table:

  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

#LI-JM1

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.  Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.  Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Learn more here

Job posted: 2021-03-20