Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures.
Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. They aim to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Their values inspire employees every day.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.
Creates and manages product strategies, roadmaps, and product specifications for all payments specific product suites.
Pathward aims to create financial inclusion for all. They are a financial empowerment company that works with innovators to increase financial availability, choice, and opportunity for all. Pathward embraces the voices of their team members, customers, partners, and the communities they serve.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.
Lead the development, manufacturing, assembly, and commercialization of high‑concentration biologic delivery systems.
Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks.
Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. It appears to be a growing company with a focus on innovation.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Lead the delivery and execution of the Behavioral Safety product roadmap
Shape the vision and strategy for the future of Behavioral Safety
Define, track and report on performance using relevant metrics
Reddit is a community-based platform that fosters open and authentic conversations. It has over 100,000 active communities and approximately 121 million daily unique visitors, making it one of the internet’s largest sources of information.
Drive the ideation and design of new products, features, or business models by analyzing market trends and customer insights to guide the product roadmap.
Formulate comprehensive product points of difference, claims, and positioning strategies to differentiate products in the market.
Lead cross-functional teams, including R&D, Brand, Commercial, Operations, and Customer Experience teams to ensure seamless execution of product strategy
Bobbie is creating a parenting culture of confidence, not comparison, starting with how we choose to feed our babies. The company crafted its European style infant formula with purposefully sourced, organic ingredients and is the only US formula designed to meet both FDA and EU standards.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Develop and lead the enterprise compliance strategy aligned with institutional growth plans and regulatory expectations.
Oversee preparation and submission of substantive change applications and institutional reporting requirements.
Establish enterprise compliance training framework for corporate and campus leaders.
Cotulla Education transforms lives through hands-on, career-focused education. They empower students to achieve their professional dreams in high-demand fields. With experienced faculty providing personalized support, their graduates emerge as future leaders ready to make a significant impact.
Develop definitional protocols to identify trust-breaching customer experiences and recommend optimal response strategies.
Establish processes for monitoring trust-breaching incidents and prepare periodic reports to leadership.
Design Trust Policies to govern marketplace participation and develop internal training processes.
ezCater is a food for work technology company in the US, connecting workplaces to over 100,000 restaurants nationwide. They provide flexible and scalable solutions for employee meals and manage food spend, backed by 24/7 customer service. They are backed by top investors and values work/life harmony.
Plays a critical role in safeguarding the integrity, accountability, and operational resilience of Global Communities’ programs and awards portfolio.
Provides strategic and technical leadership in the development, implementation, and oversight of systems that ensure proactive risk mitigation, effective grants.
Leads cross-functional efforts to identify, assess, and respond to risks across operational, fiduciary, programmatic, and safeguarding dimensions.
Global Communities champions innovative solutions to complex challenges at the intersection of humanitarian assistance, sustainable development, and financial inclusion. The approaches are dynamic and diverse as the communities it serves, bringing together local ingenuity and global insights to save lives and secure strong futures.
This position supports the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data.
Responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts.
Manages assigned operational area(s)compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people’s lives across several therapeutic areas including immunology, oncology and neuroscience.
Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Translate clinical requirements into product strategy, requirements, and execution plans.
Ensure clinical integrity, safety, and evidence alignment in product design and decision-making.
Serve as connective tissue between Product, Care Delivery, and Clinical Leadership.
Headspace provides access to lifelong mental health support. They combine evidence-based content, clinical care, and innovative technology to help millions of members around the world. Headspace values include Make the Mission Matter, Iterate to Great, Own the Outcome, and Connect with Courage.
Lead the development and implementation of regulatory and quality assurance strategies.
Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
Act as an internal SME (Subject Matter Expert) on regulatory requirements.
Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.
Design the end-to-end governance workflow for marketing approvals.
Act as the primary responsible owner for adherence to FCA rules.
Help create a healthy risk culture at Monzo.
Monzo is on a mission to make money work for everyone. They offer personal and business bank accounts, joint accounts, accounts for 16-17 year olds, a free kids account and credit cards in the UK, with more exciting things to come beyond. Monzo has a long history of creating magical moments for their customers!
Own product and portfolio positioning aligned to ICPs, buyer personas, and use cases.
Develop clear, differentiated value propositions and competitive messaging.
Translate product capabilities into outcome-oriented narratives.
They are a partner company working with Jobgether. They are looking for someone to shape the market strategy and narrative for their products, driving alignment of product messaging with customer needs, particularly for regulated and risk-oriented markets.
Oversee financial management across country offices and provide operational support to Country Directors.
Ensure global standards and compliance by embedding global standards, systems and policies in country operations and adapt them for local context.
Lead risk and crisis management across countries.
GiveDirectly aims to reshape international giving by providing cash grants directly to the world’s poorest. Our global team of ~150, and country operations teams of ~650, together come from 21 different countries speaking 69 different languages, and our culture is candid, analytical, agile, and non-hierarchical.