Works collaboratively within CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs.
Contributes to drafting, reviewing, and finalizing CMC content and regulatory documents such as Module 3 sections for INDs, BLAs, and MAAs.
Plans and manages writing projects, ensuring documents meet quality standards and adhere to corporate SOPs and evolving global regulations.
Iovance Biotherapeutics aims to be the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are an innovative biotechnology company pioneering a transformational approach to treating cancer by harnessing the human immune system.
Manages complex cross-functional design and development projects on a first in class wearable device.
Works with cross-functional team to ensure timely and complete deliverable execution.
Identifies, analyzes, and tracks project risks and issues and monitors progress to plan.
Cognito Therapeutics, Inc. translates scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. They are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world.
Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Build and scale the "Technical Playbook" for medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Hims & Hers is a health and wellness platform committed to better health by offering affordable and personalized care. As a public company traded on the NYSE, they are normalizing health & wellness challenges and innovating on their solutions to make better health outcomes easier to achieve.
Serve as primary project coordinator for Quality Risk Management processes and strategic continuous improvement initiatives.
Collaborate with cross-functional teams to ensure compliant execution of quality risk activities and analyze QMS trends for improvement opportunities.
Provide administrative support, assist in authoring SOPs, and function as a Super User for QRM technology as needed.
Vertex Pharmaceuticals is a biotechnology company focused on discovering, developing, and commercializing innovative medicines for serious diseases. It has a global workforce and a culture centered on scientific research and improving patient lives through therapeutic breakthroughs.
Plan, lead, and manage clinical trials, developing comprehensive project plans for timelines, budgets, and deliverables.
Ensure regulatory compliance by working with the Compliance Team and preparing for audits, adhering to GCP guidelines and company SOPs.
Serve as a primary communication point for sponsors and internal teams, providing regular updates and building client relationships for future business.
Paradigm Health is a company rebuilding the clinical research ecosystem by enabling equitable patient access to trials and enhancing trial efficiency. The team, backed by leading investors like ARCH Venture Partners, is multidisciplinary and committed to creating equitable access to clinical trials for any patient, anywhere.
Lead regional regulatory strategy for electric transmission projects.
Foster trust and relationships with regulatory agencies and government officials.
Advocate for policies that support the development of efficient infrastructure.
Grid United aims to solve the largest barrier to a more reliable, resilient and affordable grid by developing new long-haul electric transmission lines in the United States. Established in 2021 by proven industry leaders, Grid United is developing utility-scale, multi-state electric transmission projects that will provide long-term economic benefits to communities across the country.
Translate program strategy into integrated timelines, milestones, and deliverables.
Manage one or more highly complex R&D programs and/or high-profile partnerships.
Lead cross-functional program management activities supporting autoimmune clinical development programs.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. We are committed to transforming the future of treatment for autoimmune disease.
Lead all project initiation and planning efforts; participate in the implementation and execution of a given project.
Closely monitor/control project progression to ensure project is completed on schedule and within budget; reports project progress to all key stakeholders.
Serves as liaison with client contacts, manages day-to-day communications and organizes project team meetings.
WuXi AppTec is a leading Contract Research and Development Manufacturing Organization (CRDMO) that provides solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates. The company is an integral part of WuXi AppTec’s subsidiary WuXi STA.
Author, review, and manage clinical, regulatory, technical, and medical documents including protocols, study reports, and regulatory submissions.
Ensure strategic alignment and consistency of scientific messaging across documents while maintaining compliance with global regulatory requirements.
Drive the end-to-end writing process, manage timelines, and lead cross-functional reviews to deliver high-quality, on-time deliverables.
Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, focusing on cardiovascular indications. The company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders, empowering talented individuals to make a real impact.
Manage software implementation projects from kickoff to go-live, coordinating cross-functionally.
Proactively identify project risks and propose alternative solutions to keep timelines on track
Configure client applications using a no-code flow builder, conduct quality assurance testing.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, they surpassed $3B in revenue in their last fiscal year with extensive growth potential ahead. They are a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools.
Manages distribution, collection and tracking of regulatory documentation.
Penumbra, Inc. is a global healthcare company focused on innovative therapies. They design, develop, manufacture, and markets novel products and has a broad portfolio that addresses challenging medical conditions.
Own a portfolio of jurisdictions and act as the operational lead for everything regulatory that happens in those geos.
Partner closely with engineering and product to drive requirements development and shape how registration and compliance products are customized per market.
Translate policy and legal direction into operational playbooks and translate field signal back into product priorities.
Breezy is a global, two-sided marketplace company.
Maintain and manage the capital projects master tracker.
Organize and manage project documentation.
Coordinate communication between corporate teams, community leadership, vendors, and subcontractors.
Tutera Senior Living & Health Care is guided by one single purpose: To live the YOUNITE philosophy in every decision, every day . Founded in 1985, the company seems to offer stability and a competitive starting wage with amazing benefits.
Serves as a senior regulatory authority and trusted strategic partner to pharmaceutical and biotech C-suite executives, influencing enterprise-wide regulatory strategies.
Partners with the SVP & Practice Lead to shape the future direction of the Clinical & Regulatory practice, driving practice growth and translating regulatory landscape evolution into opportunities.
Proactively supports the practice's P&L, achieving annual revenue targets, leading pursuit strategies for high-value engagements, and setting delivery quality standards across the regulatory team.
Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner, it brings together strategy, evidence, engagement, and technology to engineer breakthrough value for clients in the healthcare sector.
Provide daily administrative support to multiple active projects.
Organize, name, version, and store files within SharePoint.
Assist with typing, formatting, editing, and organizing Standard Operating Procedures (SOPs).
Ehvert Mission Critical, a business unit within Salas O’Brien, specializes in the design and construction management of data centers. Salas O’Brien is a 4,000-person engineering and professional services firm with more than 100 offices across North America.
Lead life science customers in the configuration and implementation of Veeva’s Regulatory suite.
Manage software implementation projects and customers through the full implementation lifecycle.
Conduct configuration requirements workshops then design, prototype, configure and document content solutions.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies, they surpassed $3B in revenue and are legally bound to balancing the interests of customers, employees, society, and investors.
Support development and submission of Monthly Progress Reports and other contract deliverables.
Track Performance Requirements Summary metrics and assist with compliance monitoring.
Maintain Integrated Master Schedule updates and documentation repositories.
Nakupuna Services supports the Defense Health Agency. They likely have a collaborative and structured culture, as they require strong organizational skills.
Draft project charters, build and maintain detailed project plans, manage milestones and dependencies, and drive teams through to completion.
Analyze existing processes for bottlenecks and inefficiencies, then design and implement solutions that reduce cycle times and sharpen operational performance across the organization.
Develop and maintain SOPs, process flowcharts, and diagrams — partnering with functional SMEs to ensure documentation stays accurate, current, and usable in practice.
Personify Health created a personalized health platform—bringing health plan administration, holistic wellbeing solutions, and comprehensive care navigation together. Their team is on a mission to empower people to lead healthier lives with data-driven solutions that reduce costs while actually improving health outcomes.