Director, Regulatory Advertising and Promotion

We need to output HTML fragment with sections: About the role? The posting includes "About Genetix Biotherapeutics" then "Position Description" then "Job Duties And Responsibilities" then "Essential/Required Qualifications" then "Additional Information" then "Pay Transparency". Also mention "This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office." That's schedule info. So we need sections: About the role? Actually "About the role" heading should be used for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content accordingly. We have: - About Genetix Biotherapeutics (company description). Could be "About the role"? Actually "About the role" is for description of role. The posting includes "Position Description". That could be "About the role". We'll use

About the role

and put the Position Description paragraph. - Responsibilities: Job Duties And Responsibilities list. Use

• . - Requirements: Essential/Required Qualifications list. Use
  • . - Qualifications: maybe same as Requirements? But we can combine? The instruction: prefer few substantive sections over many thin ones. Could combine Requirements and Qualifications into one section? But they have headings: Requirements, Qualifications, Skills. We could put qualifications under "Requirements". Or we could have "Qualifications" section for the advanced degree etc. However we need to avoid filler. Let's decide: Use "Requirements" for the essential/required qualifications list. Use "Skills" maybe not needed separately. Could include "Skills" as part of same list? But we have no separate skills list. Could omit Skills section. - Benefits: Additional Information includes benefits suite description. So we can have

    Benefits

    with
    • list of benefits. - Pay: Pay Transparency range. So

      Pay

      with

      $185,000 - $285,000 USD

      . - Schedule: "This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office." So

      Schedule

      with

      Full-time hybrid (3 days a week) in Somerville – Assembly Row, Massachusetts office.

      We also need to include maybe "About Genetix Biotherapeutics" as a brief intro? Could be part of About the role? But we have company description separate. Could include as a short paragraph under About the role? The instruction: do NOT repeat the job title as a heading. The page already shows it. So we can include company description as part of About the role section. We must preserve all substantive information, not invent or summarize away detail. So we need to include all details from the posting: company values, mission, etc. Also the position description details. Also the duties list exactly as given. Also qualifications list exactly. Also benefits list exactly. Also pay range. Also schedule info. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The posting includes an EEO statement at the end: "Genetix is proud to be an equal opportunity employer...". That's boilerplate; we should remove it. Also the "Additional Information" includes pay transparency range description and bonus etc. We need to keep the pay transparency range and bonus info? The instruction: include a section ONLY when posting has real, specific content for it — never emit a heading followed by filler/placeholder text. The pay transparency range is specific; we keep it. The description about bonus etc is also substantive? It says "This role is eligible for an annual bonus and long-term incentive." That's substantive. Also "Actual base salary pay will be based on several factors..." That's also substantive but maybe filler? It's detail about how pay determined. Could keep as part of Pay section? But we already have Pay section with range; we could add a paragraph about bonus and eligibility. However the instruction: prefer few substantive sections over many thin ones. Could include bonus info in Pay section as well. Similarly, benefits description: "Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more." That's substantive; we should keep as Benefits section. We need to ensure we don't include the EEO statement. Now format: Use

      for section headings. Use

      • for any list of duties/requirements/benefits. Use

        for prose. We need to decide which content goes into lists vs paragraphs. - About the role: could be prose paragraph(s) containing company description and position description. Could split into two paragraphs: one about company, one about position description. Use

        . - Responsibilities: list of duties. The duties are given as a paragraph with sentences separated by periods. We need to turn each duty into a list item. The text: "Advertising and Promotion Oversee regulatory review of US promotional and select non-promotional materials across channels, ensuring compliance with FDA regulations and enforcement trendsServe as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) reviewPartner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and executionMonitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions. Governance, Process and Compliance Develop, maintain, and improve SOPs, workflows, tools, and training related to Ad/Prom review.Escalate issues related to MLR reviews and approvals, as needed.Drive consistency and operational excellence." We need to split into logical items. Could break at each capitalized verb after a period? The original lacks proper punctuation. We'll approximate by splitting at each major duty: Oversee regulatory review..., Serve as the regulatory lead..., Partner with Commercial..., Monitor and interpret..., Develop submission strategy..., Create and manage..., Develop, maintain, and improve..., Escalate issues..., Drive consistency... We'll create

        • for each. - Requirements: list of qualifications. The text: "Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) and strong scientific backgroundMinimum of 10 years of regulatory experience in biotech or pharmaceutical companies.Experience supporting FDA interactions related to promotional complianceExperience with MLR reviewPrior experience in cell and gene therapy or rare disease is strongly preferred.Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.Deep understanding of FDA regulations and guidance governing promotional materialsAn aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.Excellent English written and verbal communication skills.Ability to influence without authority and partner effectively with senior leaders.Strong attention to detail and accuracy with sound judgement and risk-based decision making.Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach." We need to split into items similarly. - Benefits: list as given. - Pay: include range and bonus info. Could be paragraph: "

          The pay transparency range is $185,000 - $285,000 USD. This role is eligible for an annual bonus and long-term incentive.

          " Also maybe include note about actual base salary based on factors? That's more detail but could be included. However the instruction: avoid filler/placeholder text like "commensurate with experience", "not specified", "N/A", "varies", "TBD". The statement about actual base salary based on factors is not filler; it's detail. Could include. - Schedule: paragraph. Now produce HTML fragment. Let's craft. We'll start with

          About the role

          then

          About Genetix Biotherapeutics...

          then another

          Position Description...

          . Then

          Responsibilities

          • ...
          ...
          Then

          Requirements

          • ...
          ...
          Then

          Benefits

          • ...
          ...
          Then

          Pay

          ...

          Then

          Schedule

          ...

          Make sure no extra whitespace? It's fine. Now write content. About Genetix Biotherapeutics paragraph: "At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care." Position Description paragraph: "The Director, Regulatory Advertising & Promotion is responsible for leading U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure promotional materials are compliant with regulatory requirements and aligned with corporate and commercial objectives. The Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products." Now Responsibilities items: 1. Oversee regulatory review of US promotional and select non-promotional materials across channels, ensuring compliance with FDA regulations and enforcement trends 2. Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review 3. Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution 4. Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices 5. Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities 6. Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions 7. Develop, maintain, and improve SOPs, workflows, tools, and training related to Ad/Prom review 8. Escalate issues related to MLR reviews and approvals, as needed 9. Drive consistency and operational excellence Now Requirements items: 1. Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) and strong scientific background 2. Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies 3. Experience supporting FDA interactions related to promotional compliance 4. Experience with MLR review 5. Prior experience in cell and gene therapy or rare disease is strongly preferred 6. Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority 7. Deep understanding of FDA regulations and guidance governing promotional materials 8. Aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts 9. Excellent English written and verbal communication skills 10. Ability to influence without authority and partner effectively with senior leaders 11. Strong attention to detail and accuracy with sound judgement and risk-based decision making 12. Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy