Critically evaluate scientific literature and produce accurate regulatory documents.
Manage writing assignments across multiple projects and ensure timely delivery.
Work directly with clients and multidisciplinary teams on regulatory submissions.
A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.
Lead author on complex regulatory and clinical documents including protocols, CSRs, IBs, and IND/NDA/BLA submissions.
Provide strategic input on document planning, messaging, and quality control while mentoring other writers.
Manage multiple projects independently, balancing timelines and client expectations in a fully remote environment.
Eldridge Writing provides top-tier medical writing services to pharmaceutical and biotechnology clients. We are a small, collaborative team that values quality and serves as a true extension of our clients’ teams.
Provide medical writing services and consultation to clinical research scientists and academic partners, including researching, writing, and editing scientific information.
Lead content planning and production of regulatory documents such as protocols, investigator brochures, and clinical study reports.
Act as primary contact and liaison with external publication executives and editors to coordinate content and revisions.
Alimentiv is a medical research organization providing medical writing services and consultation to clinical research scientists and academic partners. The company culture emphasizes continuous improvement and teamwork.
Craft and review regulatory documents such as clinical study reports, protocols, and investigator's brochures.
Collaborate with a supportive team to exceed client expectations.
Learn the intricacies of drug development and the science behind pharmaceuticals and biologics.
Eldridge Writing is a growing firm providing top-tier medical writing services to pharmaceutical and biotechnology clients. They pride themselves on quality and mentorship of the next generation of medical writers.
Develop and manage medical content for pharmaceutical, biopharma, and device clients, including SRDs, FAQs, and slide sets.
Drive document development from material gathering through MLR review, using tools like Veeva PromoMats.
Collaborate with global teams to ensure timely, high-quality, compliant deliverables that meet client needs.
EVERSANA provides next-generation commercialization services to the life sciences industry. With over 7,000 employees globally, the company serves more than 650 clients and is certified as a Great Place to Work, fostering an inclusive culture.
Lead development of complex medical writing and publication deliverables for clinical studies.
Define document strategies and coordinate writing activities across multidisciplinary teams.
Mentor less experienced writers and enhance processes to ensure high-quality outputs.
A global life sciences and healthcare company offering integrated services across the industry. It fosters an inclusive, collaborative culture focused on employee growth, professional development, and delivery of important therapies.
Prepares clinical and regulatory documents for drug and device development with moderate autonomy.
Coordinates review, approval, and quality control of clinical and regulatory projects.
Develops understanding of submission strategies, regulations, and project management to drive objectives.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, neuroscience, and aesthetics. The company is a global biopharmaceutical leader with a strong focus on research and development, employing thousands worldwide.
Develop high-quality clinical and regulatory documents supporting global submissions
Partner with cross-functional teams to transform complex scientific data into clear narratives
Ensure compliance with regulatory requirements while managing document timelines
Acadia Pharmaceuticals is a biopharmaceutical company developing innovative therapies to address unmet medical needs in neuroscience. With a collaborative and patient-focused culture, the company is committed to advancing treatments that improve lives.
Develop scientific expertise in assigned therapeutic areas, supporting delivery for a versatile team.
Research and develop technical materials, ensuring accuracy and adherence to editorial style.
Communicate with clients and key opinion leaders on content development and attend scientific meetings.
Nucleus Global is a global leader in medical communications, part of the iNIZIO group, providing advisory, medical, marketing, and engagement services to life sciences companies. With over 900 employees across Europe, US, and APAC, it fosters a friendly and informal working environment with social events and wellbeing programs.
Serves as regulatory document specialist for clinical trial start-up, maintenance, and close-out.
Collects, reviews, and maintains essential documents in the electronic Trial Master File (eTMF).
Communicates with study teams and sites to ensure regulatory files remain complete and inspection-ready.
St. Jude Children’s Research Hospital is a leading research and treatment center focused on pediatric catastrophic diseases. It is a large institution with a collaborative culture and a strong emphasis on finding cures and saving children.
Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.
Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.
Lead regulatory and quality strategy for product development and lifecycle management.
Coordinate regulatory submissions and maintain documentation for SaMD products.
Support design change assessments and ensure compliance with FDA, EU MDR, and ISO 13485.
Oura empowers people to own their inner potential through its award-winning Oura Ring and connected app, providing daily insights on readiness, activity, and sleep. As a quickly growing health technology company, Oura fosters a culture of empowerment and well-being, ensuring team members have the resources to do their best work.
Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.
This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.
Develop and write medically accurate content for a variety of resources, including value proposition slide decks, advisory boards, and internal training materials.
Serve as content point person on assigned accounts, ensuring high-quality work under limited supervision and strict timelines.
Collaborate with internal teams and pharmaceutical clients, attend medical/legal/regulatory review meetings, and mentor junior staff.
PRECISION AQ is a top payer marketing agency that supports global pharmaceutical and life sciences clients in commercial excellence. The company focuses on demonstrating the economic, clinical, and societal value of medical treatments to payers, providers, patients, and policymakers.
Independently manages significant aspects of clinical trials and research projects.
Trains and provides guidance to less experienced staff, and oversees data management.
Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.
Work with the Clinical Sales Manager to develop strategy for da Vinci system utilization and drive adoption.
Become an expert in da Vinci surgery across specialties to support surgical robotics program development.
Support field efforts to achieve quarterly sales goals and manage administrative tasks including reporting.
Intuitive is a pioneer in robotic-assisted surgery, developing the da Vinci Surgical System to expand physician capabilities. With over 25 years of industry leadership, the company fosters an inclusive culture and empowers team members from diverse backgrounds to make a difference.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Drafting, negotiating, and executing clinical site and ancillary agreements in compliance with country regulations and project timelines.
Tracking site contracting progress, providing clear rationales for delays, and escalating issues with contingency plans.
Acting as a country-level subject matter expert on site contracts for internal and sponsor stakeholders.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. They have built a collaborative international team across North America, South America, Europe, Asia, and Australia, valuing teamwork, flexibility, and work-life balance.
Deliver clinical education and training to physicians and hospital staff during surgical study cases in the US.
Plan activities to support recruitment at sites and ensure compliance with clinical protocols and regulations.
Support multiple studies with different protocols and travel up to 70% within the Central US region.
Kuros Biosciences is a Swiss-headquartered biotech company focused on advancing bone healing with high-quality scientific evidence. With operations in the Netherlands and the USA, we continue to grow our global team and have a commercial and research footprint spanning over 20 markets.