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.
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.
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.
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.
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.
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.
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.