Boston, Massachusetts, United States · Hybrid
$150k–$200k/yr
The Associate Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas. They will be responsible for reviewing and approving …
Skills: Regulatory affairs, Advertising compliance, Promotional compliance, FDA regulations, OPDP communication
Boston, Massachusetts, United States · Hybrid
$60k–$70k/yr
COLLECTIONS SPECIALIST We are seeking a detail-oriented Collections Specialist to join our team. In this role, you'll be responsible for reviewing cash receipts, handling attorney appeals, and ensuring timely follow-ups …
Skills: Collections, Billing, Finance, Payment processing, Invoice reconciliation
Boston, Massachusetts, United States · Hybrid
$40/hr–$46/hr
Greenberg Traurig (GT), a global law firm with locations across the world in 15 countries, has an exciting opportunity for a Legal Billing Specialist to join our Revenue Management Department. We offer competitive compen…
Skills: Legal billing, Invoice preparation, Aderant, E-billing, Analytical skills
Boston, Massachusetts, United States · Hybrid
$193k–$290k/yr
The Director, US Advertising and Promotional Compliance, will serve as the therapeutic area lead and the Regulatory Affairs (RA) representative for assigned products. They will be responsible for reviewing and approving …
Skills: Regulatory affairs, Advertising compliance, Promotional compliance, FDA regulations, OPDP liaison
Boston, Massachusetts, United States · Hybrid
DLA Piper is, at its core, bold, exceptional, collaborative and supportive. Our people are the backbone, heart and soul of our firm. Wherever you are in your professional journey, DLA Piper is a place you can engage in m…
Skills: Legal document drafting, Calendar management, Project management, Billing coordination, Records management
Boston, Massachusetts, United States · On-site
$155k–$185k/yr
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. Under the direction of the Executive Director of Sponsored Programs Administration (SPA), the Director of S…
Skills: Contract management, Grants management, Budget preparation, Financial management, Strategic planning
Boston, Massachusetts, United States · On-site
ABOUT US: Ethos Risk Services is a leading insurance claims investigation and medical management company, specializing in surveillance and fraud detection. At the forefront of, we provide accurate data and actionable ins…
Skills: Surveillance, Fraud Detection, Report Writing, Data Analysis, Computer Proficiency
Massachusetts Attorney General's OfficeBoston, Massachusetts, United States · Hybrid
$88k–$131k/yr
ASSISTANT ATTORNEY GENERAL PUBLIC PROTECTION & ADVOCACY BUREAU CONSUMER PROTECTION DIVISION (Boston or Regional Office) Attorney General Andrea Joy Campbell seeks a highly motivated attorney to join her Office’s Consumer…
Skills: Litigation, Legal analysis, Consumer protection law, Negotiation, Oral advocacy
Morgan, Lewis & Bockius LLPBoston, Massachusetts, United States · Hybrid
$81k–$105k/yr
Morgan, Lewis & Bockius LLP, one of the world’s leading global law firms with offices in strategic hubs of commerce, law, and government across North America, Asia, Europe, and the Middle East, is seeking a Legal Adminis…
Skills: Litigation support, Document processing, Court filings, E-filing, Task delegation
Stamford, Connecticut, United States · Hybrid
$130k–$150k/yr
At Franklin Templeton, we believe success is built through powerful partnerships. As a forward thinking asset manager, we build dynamic relationships with clients, understand their goals, and navigate complex markets tog…
Skills: Marketing Compliance, Regulatory Analysis, Workflow Optimization, Error Analysis, Audit Readiness
St. Petersburg, Florida, United States · Hybrid
$150k–$200k/yr
At Franklin Templeton, we believe success is built through powerful partnerships. As a forward thinking asset manager, we build dynamic relationships with clients, understand their goals, and navigate complex markets tog…
Skills: Regulatory Compliance, SEC Regulations, Investment Advisers Act of 1940, Private Equity Compliance, ETF Compliance
Boston, Massachusetts, United States · Hybrid
$83k–$157k/yr
Description Looking for an amazing new claims opportunity? Senior Complex Construction Claims Specialist — Complex CGL & Construction Liability (Litigated, $500K+) Overview Liberty Mutual’s Specialized Claims group has a…
Skills: Commercial General Liability, Construction Liability, Litigation Management, Coverage Analysis, Liability Assessment
Boston, Massachusetts, United States · On-site
Overview Who We Are MoFo is a destination law firm for talented, ambitious attorneys who value collaboration, teamwork, and commitment to excellence. We are known around the world not only for delivering innovative yet p…
Skills: Real estate law, Acquisitions, Dispositions, Construction financing, Permanent financing
Boston, Massachusetts, United States · Hybrid
$185k–$235k/yr
Head of Compliance Reporting to: Chief People Officer Location: Boston, MA (Hybrid - 3 days per week in office) Position Summary Grand Circle Corporation is the leader in international travel, adventure and discovery for…
Skills: Compliance strategy, Risk assessment, Governance, Audit methodology, Regulatory compliance
Boston, Massachusetts, United States · Hybrid
$110k–$125k/yr
What makes us Qlik? A Gartner® Magic Quadrant™ Leader for 16 years in a row, Qlik transforms complex data landscapes into actionable insights, driving strategic business outcomes. Serving over 40,000 global customers, ou…
Skills: Legal operations, Contract management, Contract negotiation, CLM administration, Matter management
American Automobile Association (AAA)Boston, Massachusetts, United States · On-site
$38/hr–$51/hr
Claims Complex Property Adjuster Job Summary This position supports the Property Claims operation by handling claims reported on Homeowner policies written by the Interinsurance Exchange in compliance with all regulatory…
Skills: Claims investigation, Coverage evaluation, Damage assessment, Negotiation, Subrogation
Boston, Massachusetts, United States · On-site
$83k–$150k/yr
Position Overview At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to …
Skills: Commercial real estate, Corporate finance, Economic policy, Financial accounting, Financial management
Boston, Massachusetts, United States · On-site
At Propio Language Services we are closing the language gap by connecting people anywhere and anytime through innovative technology and solutions. Founded in 1998 Propio Language Services provides critical interpreting a…
Skills: Consecutive Interpretation, Medical Interpretation, Legal Interpretation, HIPAA Compliance, Patient Confidentiality
Boston, Massachusetts, United States · On-site
$169k–$281k/yr
Where Ambition Meets Innovation Build a career that matches all your initiative with an impressive dose of innovation. From cutting-edge resources and a collaborative environment to the freedom to make an impact and more…
Skills: Legal Advice, ERISA, Internal Revenue Code, Regulatory Compliance, Contract Negotiation
Stamford, Connecticut, United States · On-site
$170k–$268k/yr
Who we are looking for The Global Head of Regulatory Examination Management is a senior leadership role within the Global Regulatory Liaison Office (GRLO) responsible for leading the firm’s global regulatory examination …
Skills: Regulatory examination management, Regulatory affairs, Compliance, Risk management, Executive communication
Boston, Massachusetts, United States • Hybrid
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The Associate Director serves as the Regulatory Affairs representative for promotional materials, ensuring adherence to FDA regulations and global compliance standards. They act as the primary liaison with the FDA and provide regulatory guidance to cross-functional teams during the review of promotional and scientific content.
Candidates must possess a Bachelor's degree and at least 5 years of relevant experience in advertising and promotional compliance. Proficiency in U.S. regulatory requirements and experience communicating directly with the OPDP or APLB are essential.
The Associate Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness and public affairs communications. The Associate Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials. The Associate Director may also act as the primary liaison with FDA on ad/promo regulatory issues concerning promotional materials.
Reviewing US promotional and non-promotional/scientific material, attending review meetings and providing regulatory guidance to the cross-functional team responsible for ensuring adherence to global compliance standards and FDA regulations pertaining to prescription drug advertising, promotion, and communication as applicable
Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and/or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253
As needed, providing training support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
Providing advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
Ensuring stakeholder awareness of proposed and newly approved labeling changes
Informing, reviewing and providing clear communication to all key stakeholders in both Promotional Review Committee (PRC) and Medical Review Committee (MRC) on planned label updates and how they may impact promotional and medical materials; provide key stakeholders with specific guidance on appropriate implementation of the label update, including ISI updates, for assigned therapeutic area in a timely manner
Participates in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products
Maintains regulatory expertise in product promotion compliance by keeping current with issued FDA enforcement actions and through attendance at relevant conferences and/or seminars. Communicate new regulatory standards pertaining to prescription drug promotion to brand teams and management, as appropriate
Works with management and cross-functional partners to analyze changes to the regulatory landscape and determine any internal impact and communicate and provide guidance to all impacted key stakeholders
Bachelor’s Degree
5 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience
Knowledge of U.S. advertising and promotional regulations
Experience communicating and negotiating directly with OPDP and/or APLB
Experience with global standards for advertising and promotion compliance
Knowledgeable on industry compliance requirements and non-compliance examples and trends
Experience with launching new products and/or new indication
Solid understanding of business goals and common marketing concepts/tools, including the internet and social media
Proficiency using promotional review software, such as Veeva Promomats and Veeva Medcomms
Advanced degree
7 years of relevant experience and/or relevant PharmD post-doctoral Fellowship experience
History having direct reports or mentoring junior team members
Proven track record practicing sound judgment as it relates to risk assessment
Strong interpersonal, communication, and leadership skills
Proven ability to prioritize and meet critical business timelines
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit, and autonomy of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas. As an important member of our commercial team, you'll be meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. You’re supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.
The annual base pay for this position ranges from $150,000 to $200,000 . Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Ready to make a difference? Apply now!
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
Based on 538 listings with disclosed salaries, most legal jobs in Boston, MA pay between $70k–$215k per year. Individual offers vary with seniority, company size, and specialization.
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