3 open positions available
Manage healthcare compliance operations including HCP engagement, transparency reporting, compliance systems, and process improvements. | Bachelor's degree with 2-5+ years in pharmaceutical or healthcare compliance operations, experience with compliance systems and regulatory requirements. | Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! HEALTHCARE COMPLIANCE OPERATIONS MANAGER OR SENIOR MANAGER HCP Engagement | Compliance Systems Remote (US) — Boston, MA area preferred Summary This position reports to the Assistant Director, Compliance Operations, Systems & Process Lead. The Compliance Operations Manager or Senior Manager supports the day-to-day execution of Ionis’ Healthcare Compliance Operations activities, including HCP engagement operations, transparency reporting, compliance systems, operational data quality, reporting and dashboards, and business process execution. This role serves as a key operational partner for core workflows, collaborating across Legal, Finance, Procurement, Medical Affairs, Commercial, IT, Privacy, and external vendors to support compliant, scalable, and efficient operations. The position also supports operational excellence through systems support, training assistance and coordination, technology enablement, and continuous improvement. This is a remote role for candidates in the U.S., with preference given to individuals located in or near the Boston, MA area to enable periodic on-site collaboration. Responsibilities • Provide daily Healthcare Compliance Operations support and triage for operational inquiries, including compliance mailbox management, request routing, follow-up tracking, and timely resolution. • Support the full HCP engagement lifecycle, including business needs assessments, due diligence, FMV tiering, contracting, and payment documentation • Administer HCP engagement and other compliance systems, including user support, configuration coordination, testing, troubleshooting, and issue resolution. • Support transparency reporting operations, including data collection, processing, reconciliations, validation, remediation, and reporting readiness for timely and accurate submissions under U.S. federal, state, and ex-U.S. disclosure requirements. • Manage operational data quality initiatives and partner with stakeholders to resolve data issues, monitor trends, and strengthen process controls. • Develop and maintain SOPs, business rules, process maps, work instructions, FAQs, job aids, training materials, and related communications for HCP engagement and transparency reporting processes and systems; deliver end-user training and onboarding. • Coordinate user acceptance testing, system implementations, upgrades, enhancements, and change management activities for compliance-related technologies and workflows. • Track KPIs, operational metrics, dashboards, recurring reports, and trends; recommend corrective actions and process improvements. • Develop operational reports and presentation materials using HCP engagement and transparency data. • Identify automation and emerging digital tools, including AI-enabled workflow solutions, to reduce manual effort, improve user experience, and strengthen controls. • Support audit readiness, inspections, internal monitoring activities, and regulatory inquiries by maintaining accurate, complete, audit-ready documentation, system records, and evidence of key controls. • Support broader Compliance Operations priorities, cross-functional projects, and other day-to-day operational needs as required (ex. training and communications, compliance ambassador program etc.) Requirements • Bachelor’s degree required • For the Manager position, at least 2 years of related experience in pharmaceutical, biotechnology, medical device healthcare compliance operations with a Bachelor’s degree • For the Senior Manager position, at least 5 years of related experience in pharmaceutical, biotechnology, medical device healthcare compliance operations with a Bachelor’s degree (or 3+ years with an advanced degree) • Direct experience with HCP engagement, transparency reporting, and compliance systems administration. • Strong understanding of HCP engagement lifecycle activities, including business needs assessments, FMV tiering, due diligence, contracting, payment documentation, and related process controls. • Experience working with data from multiple systems to identify trends, resolve issues, and generate operational insights. • Experience with aggregate spend and transparency reporting, including U.S. federal, state, and ex-U.S. disclosure requirements. • Knowledge of healthcare compliance requirements and industry guidance, including the Anti-Kickback Statute, FCPA, PhRMA Code, OIG guidance, and PDMA. • Experience implementing, administering, or supporting compliance technologies and digital workflow solutions including AI-enabled tools and other operational technologies • Experience with process improvement, system implementation, reporting, or cross-functional initiatives. • Strong Excel skills, plus Power BI, Tableau, or similar dashboarding and visualization tools. • Ability to translate regulatory requirements into practical, system-enabled processes. • High level of integrity and ability to protect proprietary and confidential information. • Occasional domestic travel of up to 20%. What We Seek In a Candidate • Self-motivated with strong analytical, organizational, and communication skills. • Ability to work independently and collaboratively in a team environment and convey complex information clearly to diverse audiences. • Comfortable managing multiple priorities in a fast-paced, dynamic environment. • Agile and willing to take on new projects and additional responsibilities as needed. Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004065 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits The pay scale for this position is $72,800 to $129,967 The pay scale for the Manager position is $72,800 to $106,562 The pay scale for the Senior Manager position is $90,310 to $129,967 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Lead strategic market insights vision and team to drive growth through actionable recommendations. | Extensive leadership experience in market insights, preferably in pharma/biotech, with ability to translate insights into growth strategies. | A leading biotechnology firm is seeking an Executive Director, Head of Strategic Market Insights. This role encompasses setting the long-term vision and strategy for market insights, leading a high-performing team, and providing strategic direction across various functions. The ideal candidate will have extensive experience in pharma/biotech, strong leadership skills, and the ability to translate insights into recommendations that drive growth. This position offers an attractive salary, excellent benefits, and opportunities for career development. #J-18808-Ljbffr
Lead and set strategy for enterprise-wide market insights to inform company decisions and drive growth. | 15+ years pharma/biotech market insights leadership with proven ability to influence senior stakeholders and manage high-performing teams. | Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! EXECUTIVE DIRECTOR, HEAD OF STRATEGIC MARKET INSIGHTS SUMMARY: The Executive Director, Head of Strategic Market Insights sets the long-term, enterprise vision, strategy, and standards for market insights across Ionis’ portfolio and serves as the senior leader accountable for how insights inform company-wide decisions. This role sets the long-range strategy, operating model, capabilities, and performance standards for the Market Insights function, and provides strategic direction to cross-functional partners across Commercial, Medical Affairs, Market Access, R&D, Supply, Communications, Investor Relations, and other functions, while leading a high-performing team of insights experts. You will: • Shape the end-to-end market insights agenda to inform brand, franchise, and portfolio decisions across the lifecycle. • Serve as a trusted, consultative advisor to senior leadership and cross-functional teams across Commercial, Medical, Supply, R&D, Communications, Investor Relations and other functions. • Ensure that market, patient, and customer insights are translated into clear, actionable recommendations that drive competitive advantage and sustainable growth. Your team will act as the single point of contact from Insights & Analytics (I&A) to cross‑functional partners, coordinating strategy and execution across Market Insights, Competitive Intelligence, Forecasting, and Portfolio Planning. Reporting to the VP, Insights & Analytics, this role operates with significant autonomy and executive visibility. RESPONSIBILITIES: Functional vision, strategy, and operating model • Define and drive the long-range market insights functional vision, operating model, and ways of working aligned with evolving brand, franchise, and corporate priorities to support effective decision-making • Establish and maintain enterprise-wide standards, governance, and operating principles for market insights, ensuring consistent methodologies and decision frameworks across brands, franchises, and functions. • Design and execute the annual functional plan for Market Insights, establishing clear objectives, and aligning resources and budgets with critical business needs, adapting to evolving priorities as required • Build and maintain scalable capabilities, frameworks, and knowledge management systems to maximize the impact of insights and analytics on portfolio expansion and future product launches • Champion advanced analytics, digital, and AI-enabled approaches within Market Insights, in close partnership with Forecasting and cross-functional analytics partners Leadership, talent, and culture • Lead, develop, and inspire a high performing market insights team of individual contributors and people leaders; attract, hire, and onboard new talent as appropriate, and build a team that is known for rigorous thinking, extreme attention to detail, pace, and the ability to see patterns and implications others may miss • Model and reinforce Ionis’ leadership competencies and culture principles, fostering a culture of collaboration, inclusion, accountability, and continuous improvement • Coach and develop direct reports, including timely and ongoing feedback; elevate team capabilities through mentoring, training, and stretch assignments • Creates a culture of accountability – sets clear performance standards and expectations, holds cross-functional partners and vendors to commitments, drives individual development, and productively escalates when risks to quality or timelines emerge • Drives productive debate – is not afraid to challenge assumptions, pressure-test thinking, and lead rigorous, data-driven discussions with senior stakeholders to get to the best answer Insights strategy and execution • Own creation of integrated, end to end market insights strategies and plans, prioritizing critical business questions for each brand and pipeline program • Validate and maintain long-term insights roadmaps across the product lifecycle (pre/clinical, pre launch, launch, post launch) and key stakeholder groups (HCPs, patients, payers, specialty pharmacy, etc.) • Ensure high standards for research quality and appropriate methodology, leveraging fit for purpose qualitative and quantitative primary research, secondary data, analytics, and competitive intelligence • Pressure test conclusions and implications from market insight initiatives to ensure assessments are objective, data driven, and grounded in business reality • Translate complex findings into clear, actionable insights and strategic recommendations that inform brand strategy, lifecycle management, evidence plans, and portfolio decisions • Provide forward‑looking analysis and perspective on macro market shifts, policy changes, and competitive moves, and proactively elevate risks and opportunities to leadership • Monitor and communicate key performance indicators for Market Insights impact and operational excellence, and drive continuous improvement • Identify, cultivate, and manage strategic partnerships with agencies, vendors, and experts to support efficient and high‑quality execution of insights projects, in line with industry best practices and company standards • Demonstrate extraordinary attention to detail in the design, execution, and interpretation of insights work, while maintaining a clear line-of-sight to the bigger strategic picture • Synthesize large, complex bodies of information from multiple sources at speed, distilling them into simple, actionable narratives and options for senior decision-makers • Connect non-obvious dots across markets, customers, internal data, and competitive moves to surface risks, opportunities, and inflection points before they are broadly visible Cross functional partnership and enterprise impact • Oversee the insights team in serving as the principal strategic advisors and single points of contact from I&A to their assigned brands, franchises, and above brand initiatives • Partner closely with Commercial, Medical Affairs, Market Access, Government Affairs, Supply, R&D, and other functions to ensure cohesive pull through of insights into brand / lifecycle plans, and portfolio strategy • Serve as a principal strategic advisor to senior leadership, providing executive-level recommendations on implications of market trends, customer dynamics, and competitive activity for program, franchise, portfolio, and enterprise strategy • Lead and influence strategic and tactical planning, helping cross functional teams frame choices, evaluate trade-offs, and make data driven decisions • Lead or co-lead high priority, cross functional strategic initiatives and ad hoc projects (e.g., new indication/product/market evaluations, scenario analyses, go to market strategy questions). • Reconcile dissenting views, negotiate with, and persuade others on complex and sensitive topics, applying high emotional intelligence to drive alignment and positive business outcomes • Partner with executive leaders across functions to shape company-wide policies, investment priorities, and resource allocation using data-driven insights, scenarios, and risk/benefit assessments REQUIREMENTS: • Bachelor’s degree required, advanced degree preferred • 15+ years of Pharma / biotech experience in market insights or related roles • Demonstrated success leading integrated market insights strategy for specialty and/or rare disease therapies • Experience in Neurology, Cardiology, as well as broad and rare disease markets strongly preferred • Proven track record building and leading scalable, high‑performing teams, including people leaders • Diverse commercial background (e.g., prior roles in Marketing, Sales, Strategy, or Market Access) with mastery of how insights inform P&L, investment decisions, and resource allocation, strongly preferred. • Demonstrated ability to lead through ambiguity, create structure, synthesize multiple data sources into coherent, actionable narratives and recommendations, driving alignment on complex, cross functional issues • Deep experience in the U.S. market launches required, global market insights experience preferred • Strong executive presence with a proven ability to influence cross‑functional and enterprise‑level decisions, including VP/EVP‑level stakeholders • High emotional intelligence, with a track record of reconciling dissenting views, negotiating tradeoffs, and driving to outcomes that balance enterprise, functional, and brand needs • Excellent judgment and willingness to take prudent risks, grounded in objective data and market realities • Innate curiosity and entrepreneurial spirit, with strong personal drive and ownership • Insatiable learner with demonstrated ability to rapidly get smart on new therapeutic areas, markets, and methods, and to continuously raise the bar for the function • Proven ability to operate in a high-velocity, fast-changing environment, setting pace and priorities for others while maintaining composure and sound judgment • Exceptional conceptual thinking and pattern recognition skills, with a track record of spotting connections and implications that are not obvious to others Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004011 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits The pay scale for this position is $230,000 to $265,000 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. #LI-Remote
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