Preparation of Initial Investigational New Drug (IND) applications and amendments.
Provide guidance and support to other in‑house units in the preparation or review of manuals, training guidelines, and similar documentation.
Serve as a resource for new medical writers, offering direction, feedback, and support as needed.
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Their focus is cancer, understanding the science behind each potential cancer therapy and the challenges of moving therapies from mice to man.
Drafts and maintains medical information content for the Medical Information Call Center (MIC).
Provides guidance to Medical Information Managers on drafting standard medical responses and FAQs.
Reviews MIC case records to ensure accuracy of response and compliance with regulations.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for serious diseases. The company is consistently recognized as one of the industry's top places to work, with a diverse and inclusive culture.
Draft and copyedit submissions for abstracts, posters and peer-reviewed manuscripts.
Work collaboratively with other team members and actively participate in pub planning activities.
Perform fact/data check on writing documents (manuscripts, white papers, dossiers, etc.).
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated professionals from world-class institutions, who care deeply for our work and each other.
Plays an essential role supporting Global Medical Information / Medical Content Development Team on content development-related engagements.
Writes and creates medical and scientific content related to Medical Affairs, Medical Information and Medical Communications.
Drives the client document development process from gathering materials and developing scientifically rigorous content to facilitating document review.
EVERSANA delivers next-generation commercialization services to the life sciences industry, helping bring innovative therapies to market and supporting patients. They have over 6,000 employees, embracing diversity and inclusion to improve patient lives around the world.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
Review, annotate, and amend publication manuscript drafts to tight deadlines.
Work on rapid turnaround deliverables following guidance set by Sci Comms Solutions Lead.
Liaise with Authors to take manuscripts to submission.
Sorcero's medical AI platform transforms life sciences decision-making, accelerating patient access to life-saving treatments. Sorcero is a Certified B Corp headquartered in Washington, DC, recognized by over a dozen awards, including Fast Company's Most Innovative companies of 2024.
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.
Develop, execute, monitor, and adapt strategic MSL stakeholder engagement plans.
Lead high-quality scientific exchange through both proactive and reactive interactions.
Identify and communicate insights, trends, and activities of other Medical Affairs organizations.
They focus on engaging key opinion leaders (KOLs) and healthcare providers in high-quality scientific exchange. They drive insight generation and contribute to the development and execution of medical strategy.
Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Lead end-to-end Clinical Data Management activities for assigned clinical studies.
Ensure clinical data are accurate, complete, consistent, and inspection-ready.
Drive proactive risk identification, issue escalation, and resolution across study teams and vendors.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease, guided by core values and focused on innovation.
Partner with Clinical Operations leadership to support clinical trial execution.
Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites.
Provide guidance and oversight to CRAs, including trip report review and training support.
Immatics is dedicated to making a significant difference in the lives of cancer patients. They are a global frontrunner in precision targeting of PRAME, found in over 50 cancers, with cutting-edge science and a strong clinical pipeline.
Lead and support all programming activities for clinical studies, including developing Tables, Figures, and Listings (TFLs) using SAS for Clinical Study Reports and regulatory submissions.
Work independently to implement programming strategies, ensure compliance with standards, and contribute to best practices for quality and efficiency.
Communicate and escalate risks, support team activities, and coordinate with biostatisticians to customize outputs for target audiences.
ClinChoice is a global full-service clinical research organization specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience and more than 4,000 professionals across 20+ countries, the company fosters a supportive culture focused on quality, professional development, and low employee turnover.
Lead day-to-day data management activities for assigned clinical trials.
Oversee CRO and vendor data management deliverables to ensure timelines, quality, and compliance.
Ensure data integrity, consistency, and completeness through ongoing data review and cleaning.
Faeth Therapeutics is a clinical-stage oncology company advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program. They are a small, focused team where every person has direct impact and are united by a shared commitment to care deeply, create boldly, and never stop learning.
Planning, development, and oversight of scientific content for assigned accounts.
Leading client interactions and brand strategy, as well as the scientific portion of brand planning and business development.
Managing resource allocation, partnering with client services to develop SOWs and timelines and identifying areas for new and organic growth.
Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our flexible structure provides better work-life balance; they attract the best talent and are more responsive to their clients.
Drive the day-to-day execution across PRP commercialization workstreams, ensuring deliverables remain on track.
Coordinate the work with cross-functional teams required for program success.
Conduct targeted research to identify experts, consultants, and specialized partners who can support key PRP commercialization needs.
Genus is an agricultural biotechnology pioneer that is a global FTSE 250 company. We have a global workforce of over 3,000 employees, and our vision is clear: Pioneering animal genetic improvement to sustainably nourish the world.
Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.
Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.
Responsible for CMC regulatory activities globally for assigned projects and adapts swiftly to changing events and priorities.
In charge of CMC strategy development, with management support, for CMC submission dossiers to support lifecycle management.
Ensures that information submitted in support of life cycle maintenance applications meets regional requirements, allowing maximum flexibility in supply, manufacturing and quality.
Alphanumeric recruits for one of the largest pharmaceutical companies in the world, headquartered in Montreal, Quebec. They are helping them find a Responsable des affaires réglementaires internationales CMC to work remotely in Quebec or Ontario.
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.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.