Develop new processes for medical devices and components.
Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally, as required.
Lead cross-functional team to plan and implement changes and improvements to operational systems and processes.
Penumbra, Inc. is a global healthcare company focused on interventional therapies. They design, develop, manufacture and market innovative medical devices and have a strong focus on collaborative team culture.
Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development.
Lead human factor engineering activities as per the regulatory guidelines.
Manage project and program budgets and timelines effectively.
Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind. They seem to have a collaborative culture.
Partner with Regulatory leads to manage regulatory filing subteams and subteam operations.
Develop and maintain high level and detailed regulatory timelines that utilize project management software tools.
Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays.
Ultragenyx is a biopharmaceutical company committed to addressing unmet medical needs in the field of rare diseases. With a focus on innovation and patient-centricity, they strive to develop life-changing treatments and improve the lives of patients and caregivers.
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.
Leads projects from conception through close-out, ensuring detailed planning and execution, risk management, communication and stakeholder management, scope and cost control.
Creates and manages project timelines, budgets and revenue goals, forecasting, resource plans, while comparing to contracted project scope(s), fully exploring new ideas that optimise quality and efficiency.
As the face of the company and key partner to clients and collaborators, effectively leads implementation of new and ongoing studies.
Precision for Medicine accelerates the development and adoption of novel therapeutics. They focus on assay development and clinical testing, biorepository/sample management and logistics, and kitting for client studies spanning the globe.
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.
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.
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.
Lead Talkdesk’s Strategic HLS Healthcare & Life Sciences (HLS) customer implementation projects from kick-off to completion.
Manage multiple customer projects simultaneously; work with customers, partners, & internal solutions consultants to drive positive progress.
Proactively identify risks pertaining to time, scope, & budget and develop comprehensive mitigation strategies with clear communication plan.
Talkdesk is pioneering a new era of Customer Experience Automation (CXA), redefining how the world’s most admired brands interact with their customers through AI. Its global team of innovators is customer-obsessed and building AI-first solutions that put empathy, trust, and transparency at the center of every interaction.
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.
Manages design and construction related activities for capital projects.
Manages project communications, contract administration, and change orders.
Interfaces with hospital operations leadership for project coordination.
CommonSpirit Health delivers integrated health services, driven by innovation and humankindness. As one of the nation’s largest nonprofit Catholic healthcare organizations, we have over 157,000 employees across 24 states.
Create detailed project plans including setting targets for milestones, adhering to deadlines, reporting processes and allocating resources in accordance within the digital strategy.
Apply project management tools, methodologies and best practices to ensure the on-time launch and flawless execution of projects from concept to end.
Identify and manage potential risks and liabilities; identify project management coordination gaps or areas of improvement and make effective decisions.
FuseGlobal is a partnership of people and brand-leading companies, working together to make things run better. For 25 years we have brought functionality to complex business and production processes and supply chains, resulting in enterprises that run smarter and more sustainably.
Lead end-to-end packaging program execution for new product development, special editions, and sustaining changes from concept through launch and post-launch support.
Build and manage integrated schedules, milestones, dependencies, critical paths, and decision logs for packaging deliverables across engineering, operations, and commercial teams.
Partner across Packaging Engineering, Product Management, Design, Hardware Engineering, Operations, Supply Chain, Quality, Regulatory, Creative, and Marketing to align technical, business, and brand requirements.
Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.
Drive implementation from end to end, both internally and externally with client teams
Partner with health plan and risk bearing provider clients to successfully launch Cohere Health products within their organization
Act as the key liaison between client implementation team and cross functional teams at Cohere to drive day to day implementation activities
Cohere Health's clinical intelligence platform delivers AI-powered solutions that streamline access to quality care by improving payer-provider collaboration, cost containment, and healthcare economics. The company works with over 660,000 providers and handles over 12 million prior authorization requests annually, and is backed by leading investors such as Deerfield Management. The Coherenauts who succeed here are empathetic teammates who are candid, kind, caring, and embody our core values and principles.
Manage day-to-day relationships with pharmaceutical customers, identify growth opportunities, and provide ongoing communications.
Provide subject matter expertise related to past industry experience during projects as appropriate.
Draft/update project deliverables and well-organized presentations to a high level of quality.
Archbow Consulting leverages industry expertise in a consultant capacity to support pharmaceutical and biotech companies. They are committed to hiring and developing exceptional talent and focused on developing inclusive teams that can bring the best solutions.