Vertex Inc. logo
Vertex Inc.

Vertex is a global biotechnology company that invests in scientific innovation.

Director, Regulatory Labeling Strategy

StrategyStrategyFull TimeRemoteLeadTeam 1,001-5,000

Location

United States

Posted

5 days ago

Salary

$185.6K - $278.4K / year

Seniority

Lead

No structured requirement data.

Job Description

Director, Regulatory Labeling Strategy

Vertex Inc.

Role Description The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products. This role will be responsible for the development and maintenance of global product labeling across a therapeutic area. This will include: - Target labeling profiles (TLP) - Company core datasheets (CCDS) - Local labeling (prescribing information, patient information) for major markets This role will be accountable for specific labeling business processes. Key Duties and Responsibilities - Ensures compliance with labeling governance requirements and associated business processes. - Leads label working groups (LWG) and represents labeling at product-specific global regulatory teams and senior labeling governance meetings: Label Review Group (LRG) and Executive Label Review Group (ELRG). - Plans and leads development and maintenance of global product labeling for one or more products, including CCDS and regional labeling (Prescribing Information [PI], Patient Information [PIL], Instructions For Use [IFU]) for select markets (e.g., US, EU, GB, CA). - Leads labeling strategy with expert ability to advise stakeholders of regulatory labeling requirements and provide oversight of health authority interactions (responses to questions, negotiations, and inspections) regarding all aspects of labeling. - Conducts research related to labeling precedent, regulations, policies, and other topics as necessary to properly advise on potential labeling impacts, strategies, or outcomes. - May lead one or more therapeutic areas and be responsible for the strategic development and lifecycle management of labeling for that/those area(s), including TLPs. Knowledge and Skills - Experience leading labeling development and regulator negotiation activities for an initial marketing application or major indication expansion. - Ability to synthesize complex concepts and actions into simple and clear messaging; communicating at all levels of the organization, from specialized experts to executive management. - Specialized depth of knowledge regarding labeling requirements globally, including development and life-cycle management of CCDS and of global regulatory authorities, including the FDA, EMA, and may include other authorities such as Health Canada, TGA. - Advanced ability to develop, use, and apply knowledge of frameworks specific to regulatory labeling, and to use this information to support regulatory responsibilities that align with business objectives. - Advanced ability to plan, prioritize, lead, and execute individual work, teamwork, and projects related to regulatory labeling in a systematic and efficient manner. - Strong attention to detail with a quality-driven mindset. - Strong understanding of the compliance and operational requirements for labeling. - Demonstrates the ability to effectively adopt and leverage emerging technologies, including structured content management for labeling, AI-driven tools, and eLabeling technologies. - Maintains a continuous learning mindset to strengthen Regulatory Labeling decision-making and operational efficiency. - Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment. Education and Experience - Bachelor’s degree - Typically requires 10 years of experience in regulatory affairs in the area of global labeling or related discipline, or the equivalent combination of education and experience. Pay Range $185,600 - $278,400 Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. Benefits At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations: - Medical, dental and vision benefits - Generous paid time off (including a week-long company shutdown in the Summer and the Winter) - Educational assistance programs including student loan repayment - A generous commuting subsidy - Matching charitable donations - 401(k) and so much more Flex Designation Remote-Eligible Flex Eligibility Status In this Remote-Eligible role, you can choose to be designated as: - Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; - Hybrid: work remotely up to two days per week; - On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Related Categories

Related Job Pages

More Strategy Jobs

NORC at the University of Chicago logo

Senior Associate - Health Care Strategy

NORC at the University of Chicago

NORC at the University of Chicago is an objective, nonpartisan, nonprofit academic research organization serving the public interest by delivering objective ana

Strategy7 days ago

Title: Senior Associate - Health Care Strategy - Bethesda, Chicago or Remote Location: Bethesda, MD - Maryland - Bethesda MD Job Description: NORC at the University of Chicago seeks a Senior Associate with health care expertise to join the Health Care Strategy Department. This unit supports a range of health care companies and stakeholders, including health plans, providers, disease groups, federal and state governments, associations, and foundations. This position reports to a Director within Health Care Strategy. The successful candidate will play a significant role in assisting a world-renowned non-profit research organization to meet the challenges of a rapidly evolving research landscape. The Senior Associate must thrive in a fast-paced environment and quickly comprehend and act on changing priorities when necessary. NORC is seeking a candidate who wants to come to work every day energized and ready to add value through hard/smart work, critical thinking and creative insights. This candidate will join a cohesive and motivated team that likes to have fun while doing great work. This is also a team that takes an active role in mentoring staff so that they successfully develop their careers over the long time. NORC recognizes that talented and skilled researchers live throughout the U.S. and actively supports remote work arrangements. DEPARTMENT: Health Care Strategy NORC’s Health Care Strategy Department delivers consulting, data analysis, and research services to health care industry clients, including plans, providers, associations, foundations, long-term care, and disease groups. We are a new, rapidly-growing business line within a well-established research institution. HCS experts guide critical decision-making in business and policy by translating complex information into actionable knowledge. We work closely with our clients to ensure our work is targeted, scalable, and impactful. Our services include policy analysis, data analytics and visualization, predictive modeling, consumer research, custom surveys, and program evaluations. RESPONSIBILITIES: - Supports quantitative and qualitative projects for health care clients working closely with senior staff. - Conducts original research, literature reviews, and analysis on critical health care issues. - Engages directly with client contacts to support project management functions, including meeting scheduling and updates on project timelines and budgets. - Creates original drafts of deliverables in Word, PowerPoint, and Excel with strong executive summaries, clear and concise writing, and visual appeal. - Collaborates with colleagues across NORC to coordinate on projects or engage experts for input on project work. - Manages individual assignments effectively, including appropriate prioritization of activities and on-time delivery REQUIRED SKILLS: - Bachelor's degree from an accredited college or university. Masters Degree preferred. - At least 2 years work experience in health care research or consulting - Strong interpersonal skills and ability to work effectively with multiple departments, stakeholders, and internal and external clients - Excellent written and verbal communication skills, as well as strong active listening skills. - Strong critical thinking skills - Must be able to work with minimal supervision and have well-developed problem-solving and decision-making skills - Results driven, self-starter who thrives in a fast-paced, rapidly evolving work and market environment - Must be flexible and able to able to prioritize and manage multiple projects with solid performance/results - Demonstrated project management experience - Must be a team player who has a proven ability to work with multiple layers of the organization (including C-level executives) - Proficiency with Microsoft Office, with a particular expertise in Word, PowerPoint, and Excel - Proficiency with content management processes and tools, SharePoint experience a plus - Attention to detail - Basic knowledge of graphic design programs such as InDesign or Photoshop is preferred - Experience in and passion for nonprofit/public sector communications is preferred. WHAT WE DO: NORC at the University of Chicago is an objective, non-partisan research institution that delivers reliable data and rigorous analysis to guide critical programmatic, business, and policy decisions. Since 1941, our teams have conducted groundbreaking studies, created and applied innovative methods and tools, and advanced principles of scientific integrity and collaboration. Today, government, corporate, and nonprofit clients around the world partner with us to transform increasingly complex information into useful knowledge. WHO WE ARE: For over 80 years, NORC has evolved in many ways, moving the needle with research methods, technical applications and groundbreaking research findings. But our tradition of excellence, passion for innovation, and commitment to collegiality have remained constant components of who we are as a brand, and who each of us is as a member of the NORC team. With world-class benefits, a business casual environment, and an emphasis on continuous learning, NORC is a place where people join for the stellar research and analysis work for which we’re known, and stay for the relationships they form with their colleagues who take pride in the impact their work is making on a global scale. EEO STATEMENT: NORC is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. NORC evaluates qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, sexual orientation, gender identity, and other legally- protected characteristics.

United States
Revive Media logo

Senior Account Lead, Strategy

Revive Media

Amazon Focused Digital Marketing Partner

Strategy7 days ago
Full TimeRemoteTeam 11-50Since 2014H1B No Sponsor

Role Description This role sits within our Amazon pod and combines strategic account ownership with relationship-building across Amazon's platform ecosystem. You'll manage our largest, most strategic client relationships end-to-end, while also working closely with Amazon partner teams to strengthen those connections over time to help build in new leads. The role blends external relationship work with hands-on account management, so it suits someone who's comfortable both leading client conversations and doing the operational work behind the scenes. Responsibilities - Own the relationship and revenue for a portfolio of our largest, enterprise-level accounts - accountable for retention, growth, and overall account health. - Build and deepen trusted relationships with our Amazon partner teams, positioning Revive as a go-to partner they confidently refer clients to (including in-market travel as needed). - Lead strategic client conversations, particularly for top accounts, and represent Revive to senior stakeholders (C-suite, directors). - Drive pre-sales strategy, campaign analysis, reporting, and quarterly business planning for your accounts. - Manage the internal and technical side of accounts - our platform tools, agency onboarding, and RFP processes. - Represent client needs back to Product and Partnerships to help shape features and improvements. - Collaborate closely with Media Ops, Partnerships, Product, and your own Strategy team. Qualifications - 7+ years in account development, account management, or sales, ideally within ad tech or digital media. - Solid understanding of the advertising/ad tech sales cycle, client needs, and buying behaviors, plus working knowledge of DSPs, SSPs, and the broader ad tech ecosystem (Amazon DSP a plus). - Proven track record managing enterprise-level accounts and multi-million-dollar client relationships. - Comfortable presenting to senior stakeholders (C-suite, directors) and operating in a relationship-driven, channel-style model rather than cold outbound. - Hands-on mindset - willing to learn our internal tools and platforms, not just manage from the outside. - Excellent written, verbal, and consultative communication skills. - Ability to legally work in the United States. Preferred Qualifications - Technical understanding of ad serving technologies and data management platforms. - Track record of expanding client relationships - revenue growth, retention, cross-selling. - Prior experience or interest in managing or mentoring others. - Experience introducing performance measures or process improvements that scale. Benefits - 100% healthcare coverage for employees, 50% for dependents (medical, dental, vision). - Flexible remote work, including a home office stipend, internet reimbursement, and wellness stipend. - Unlimited PTO. - 3-day weekend every month. - Monthly coffee or tea subscription. Compensation Revive Media provides the wage it reasonably and in good faith expects to pay for all remote roles and as otherwise required by applicable law. The expected annual base pay for this role is $140k-$155k + quarterly bonus. Actual compensation may vary within the listed range based on a wide array of factors including, but not limited to, skill set, experience, and specific geographic location. The range listed is just one component of our total compensation package for employees and does not include equity and variable pay. Equal Opportunity Employer Revive Media is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We assess all qualified candidates on the basis of skill, experience and talent.

United States
$140K - $155K / year

Title: CNS Therapeutic Strategy Lead Location: United States Job Id: 168597 Job Category: Job Location:  Remote Security Clearance: No Clearance Business Unit: Piper Companies Piper Companies is hiring a Therapeutic Strategy Lead for a mid-size CRO headquartered in Australia. The Therapeutic Strategy Lead is highly client-facing and focuses on designing scientifically robust, operationally feasible, and commercially competitive strategies across CNS and Neurology. The Therapeutic Strategy Lead is a remote opportunity and will need to work US Based hours.   Responsibilities for the Therapeutic Strategy Lead: - Serve as the primary therapeutic expert for proposals, bid defenses, and early study concepts, delivering strategic insights and risk mitigation plans. - Build and maintain relationships with Principal Investigators (PIs), academic KOLs, and high-performing sites to optimize enrollment and data quality. - Provide scientific leadership for protocol design, feasibility assessments, and regulatory strategy, ensuring alignment with global standards of care. - Translate therapeutic science into operational requirements, including timelines, budgets, and vendor selection. - Mentor internal teams on therapeutic best practices and contribute to thought leadership initiatives. Requirements for the Therapeutic Strategy Lead: - Advanced Medical Degree (MD, DO), board certification is required. - Strong scientific background with proven credibility in clinical development and therapeutic strategy. - Ability to engage directly with PIs and KOLs; established network in relevant therapeutic areas preferred. - Experience in late-phase clinical programs and commercial-facing strategy within a sponsor, CRO, or academic setting. Compensation for the Therapeutic Strategy Lead: - $300,000 - $400,000 base salary - Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law   Keywords: therapeutic strategy, clinical development, global CRO, protocol design, study feasibility, scientific leadership, KOL engagement, site selection, late-phase trials, regulatory strategy, endpoint selection, safety monitoring, clinical operations, medical services, business development, bid defense, proposal development, drug development, operational planning, budgets, timelines, vendor management, strategic thinking, clinical expertise, thought leadership, commercial acumen, investigator relationships, competitive landscape, feasibility assessment, clinical program design, cross-functional collaboration, clinical trial optimization, therapeutic area expert   #LI-AG1 #REMOTE

United States
$300K - $400K / year
Strategy8 days ago
Full TimeRemoteTeam 201-500Since 2023H1B No Sponsor

• Deliver your brands’ strategic narrative in board decks, all-hands presentations, and investor materials • Own quarterly business reviews for your brands • Lead the end-to-end budget, forecast, and projection process • Collaborate with functional organization leads to execute their functional strategy • Drive recommendations on brand-related initiatives • Facilitate high-touch cross-functional response to solve urgent, high-impact issues • Conduct root cause analysis on significant business trends

United States