Develop and maintain a structured research roadmap aligned with organizational clinical priorities.
Analyze large clinical and administrative datasets using appropriate statistical methods.
Lead authorship and coordination of abstracts, posters, and manuscripts for CV conferences and journals.
Heartbeat Health is the leading virtual-first cardiovascular care company. They provide patients convenient, high-quality heart care, leveraging real-time data and AI-powered insights to empower providers and patients with personalized treatment plans. The company is remote-first with flexibility and autonomy at the core.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Develop content for healthcare professionals, strategically planning technical and creative material.
Drive engagement with healthcare professionals, ensuring content aligns with brand voice and regulations.
Translate complex scientific information into clear language, understanding medical terminology and compliance.
Montu is Australia's largest healthtech business focused on alternative healthcare. Founded in 2019, they support patients, doctors, and pharmacies through their clinic and education/dispensing platforms and are the founding member of Cannabis Council Australia. They are driven and results-focused, where ambitious individuals can push the boundaries of innovation and contribute to better outcomes.
Author administrative and CMC regulatory documents in collaboration with SMEs.
Manage full CMC submissions, ensuring compliance with requirements.
Jobgether is a company that uses an AI-powered matching process assisting partner companies with their recruitment needs. They aim to ensure applications are reviewed quickly, objectively, and fairly.
Generate content outlines that contain a clearly highlighted story arc and a complete reference list.
Develop client-ready drafts of content in various forms (slide decks, summaries, meeting materials).
Confer with teams in the medical/legal/regulatory review process, answering queries and implementing the required changes.
Precision Medicine Group translates the science of medicine into high-level strategy, tactical communication, and flawless execution. They have long-tenured relationships with major pharmaceutical companies and leading biotech firms, holding a leadership position in strategic medical communication and training solutions.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
Lead development and execution of global regulatory strategy.
Act as a subject matter expert in regulatory affairs for product introduction.
Participate in quality system and design dossier audits.
Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.
Independently develop high-quality, medically accurate content.
Collaborate with internal teams to create compelling content.
Liaise with clients and stakeholders on strategy and content.
Precision AQ is a payer marketing agency that supports global pharmaceutical and life sciences clients in achieving commercial excellence. They focus on demonstrating the value of medical treatments to various stakeholders, contributing to improved patient care worldwide.
Serves as the project physician and provides medical and scientific expertise to project teams.
Ensures the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety.
Participates in the strategic planning and execution of critical development programs for clients in Oncology/Haematology.
Precision for Medicine improves the clinical research and development process for new therapeutics. Their novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step.
Support content development needs of the Clinical Services department.
Act as the medical lead in the creation and presentation of strategic plans.
Supervise 6+ Clinical Services team members directly and indirectly.
Precision AQ supports global pharmaceutical and life sciences clients in the achievement of commercial excellence. They excel at demonstrating the economic, clinical, and societal value of creative medical treatments. The company has a client service, purpose, accountability, mutual respect and collaboration culture.
Lead the planning, execution, and management of clinical trials.
Ensure compliance with FDA, ICH-GCP, and other regulatory standards.
Supervise and mentor Clinical Research Associates (CRAs) and study coordinators.
Jobgether leverages AI to match candidates with fitting roles, ensuring quick and fair application reviews. They connect top candidates directly with hiring companies, who then manage the final decision-making process.
Represent the Regulatory Affairs function within project teams.
Develop and implement regulatory strategies that support business goals.
Collaborate with international partners and internal teams.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
Responsible for a range of editorial services and leading the editorial work for assigned accounts.
Copy edit each project for correct spelling, grammar, consistency and preparing submissions of pharmaceutical marketing materials.
Prioritize multiple deadline-sensitive projects, take ownership, and work independently.
Precision Medicine Group is a company that works in the medical communications field. They are an equal opportunity employer, and employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Drive global regulatory strategy for peptide and nucleic acid-based products.
Collaborate with teams to ensure compliance with international standards.
Prepare CMC documents and regulatory submissions for complex products.
Jobgether is dedicated to connecting talent with opportunities. They leverage AI-powered matching to ensure applications are reviewed quickly and fairly, identifying top candidates for hiring companies.
Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations
Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking
Remain current on regulations and best practices within the industry
Nuvalent is dedicated to creating selective medicines to address the unmet needs of patients with cancer, leveraging their expertise in chemistry. As an early-stage entity, Nuvalent brings together seasoned scientists and industry experts with a strong history in oncology drug development, drug discovery, and company building.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Assist in project planning and execution, translating objectives into timelines and milestones.
Collaborate across scientific, computational, and business teams to facilitate coordination.
Monitor project progress, identify obstacles, and communicate updates to stakeholders.
Altos Labs is focused on restoring cell health and resilience through cell rejuvenation to reverse disease, injury, and disabilities. They bring together scientists and industry leaders from around the world, and they value diverse perspectives and a culture of belonging.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
Be the voice of key opinion leaders and healthcare professionals, providing insights into product development opportunities and facilitating scientific exchange.
Deliver impactful presentations and drive strategic engagement with various stakeholders.
Contribute to advancing medical goals in neuromuscular diseases and beyond.
Jobgether is a platform that connects job seekers with companies. They use an AI-powered matching process to ensure applications are reviewed quickly and fairly.