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.
Author aggregate safety reports including PBRER, PSUR, DSUR, and others for submissions to health authorities.
Coordinate with stakeholders to obtain data, plan timelines, and ensure timely delivery of reports.
Mentor junior team members, conduct training, and maintain awareness of regulatory guidelines.
ClinChoice partners with pharmaceutical, medical device, and consumer care companies to accelerate clinical trials and ensure product safety. With a global delivery network spanning multiple countries, they provide expertise in clinical operations, biometrics, pharmacovigilance, and more.
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.
Provide support to other activities undertaken by the project team on behalf of the client and the company.
Create and maintain project-specific KPIs for contracted ICSR activities, proposing process changes to the ICSR Operational Lead.
Manage ICSR deviations, review trackers and timesheet data for accuracy, and operate as the assigned team SME.
PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. The company operates across Europe, North America, South America, Asia, and Australia in a culture built on kindness, flexibility, growth, and belonging.
Independently plans and prepares regulatory documents and medical communications to support all phases of product development.
Organizes, analyzes, interprets, and presents scientific and statistical information in accordance with industry guidelines (ICH, ICMJE, GPP).
Collaborates with cross-functional internal and external teams under direction of Medical Writing management.
Veristat is a global contract research organization that accelerates life-changing therapies to patients worldwide. With over 30 years of expertise, the company has supported more than 105 approved therapies and fosters a flexible, inclusive culture with 70% remote workforce and 66% women-led teams.
Support the development and management of clinical guidelines by coordinating with physicians and committees.
Manage program workflows, documentation, and communications to ensure efficient execution.
Maintain compliance with healthcare regulations and contribute to impactful quality and safety initiatives.
The company supports the development and management of clinical guidelines to advance quality, safety, and evidence-based healthcare practices. They foster a collaborative, mission-driven culture focused on innovation, integrity, and professional growth.
Conduct remote and onsite monitoring activities including Site Initiation, Interim, and Closeout Visits.
Review informed consent, source documentation, and case report forms for accuracy and completeness.
Identify, document, and escalate protocol deviations, data quality concerns, and compliance risks.
WHOOP is on a mission to unlock human performance and healthspan, empowering members to perform at a higher level through a deeper understanding of their bodies and daily lives. They are a leading wearable technology company with a collaborative and detail-oriented culture.
Provide comprehensive project coordination and administrative support for clinical research studies.
Coordinate meetings, maintain project documentation, and monitor tracking systems.
Support compliance with internal processes and assist with study startup, maintenance, and closeout activities.
The company is a clinical research organization that supports the development of life-changing therapies through innovative programs. It operates with global teams and fosters a collaborative, inclusive work environment committed to teamwork, integrity, trust, and respect.
Develop and maintain clinical data listings, reports, and programming solutions to support data review and safety monitoring.
Analyze requirements from Data Management and Risk-Based Study Management teams and create efficient programming solutions.
Ensure all activities comply with regulatory requirements, industry guidelines, and internal procedures.
A partner company in the clinical research industry supports global clinical research programs through data analysis and programming. The company offers a fully remote, collaborative environment with a focus on continuous learning and improvement.
Assist clinicians with gathering medical information for patients in between visits using various electronic health record systems.
Report medical concerns monthly such as falls, medications, behavioral issues, and hospitalizations.
Complete PCM interventions each month for approximately 15 patients per day.
MTC Care is the nation's leading telemedicine provider of behavioral health care to skilled nursing and assisted living facilities. They are an equal opportunity employer committed to fostering an inclusive workplace.
Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.
Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.
Manage patient communications, including phone calls, emails, and appointment scheduling.
Coordinate specialist referrals, insurance authorizations, and test results.
Provide administrative support such as pharmacy refills, EHR maintenance, and workflow tracking.
Assist World is a staffing agency recruiting for a busy and growing U.S. medical practice. They emphasize remote work, no tracker policies, and a supportive environment.
Independently plans and prepares regulatory documents and medical communications for all phases of product development.
Organizes, analyzes, interprets, and presents scientific and statistical information per ICH guidelines.
Collaborates with cross-functional internal and external document production teams.
Veristat is a global contract research organization with over 30 years of expertise accelerating life-changing therapies to patients worldwide. The company has a flexible, inclusive culture with a 70% remote workforce and 66% women-led teams.
Lead the preparation of complex clinical and regulatory documents including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures.
Collaborate with clinical development teams and stakeholders to produce accurate, compliant, and scientifically robust documentation.
Manage document timelines, review cycles, and project deliverables while ensuring quality standards and regulatory requirements are met.
Our partner is a specialized medical writing team supporting the development of high-quality regulatory documentation for the global pharmaceutical industry. It offers a collaborative, remote environment focused on quality, precision, and scientific communication.
Coordinate clinician onboarding by maintaining accurate ATS records and distributing required credentialing documentation.
Verify licenses, certifications, education, and background checks to ensure compliance with state, federal, and Joint Commission standards.
Track expiring credentials, communicate renewal requirements, and proactively manage compliance deadlines to maintain clinician eligibility.
International SOS Government Medical Services supports healthcare programs that improve patient care and operational readiness across the U.S. and internationally. Founded in 1984, the company operates in more than 90 countries, delivering healthcare, medical assistance, emergency response, and workforce support services worldwide.
Creates and maintains project timelines in MS Project or similar systems, ensuring accurate updates and distribution to team members.
Coordinates internal and external meetings, prepares agendas, takes minutes, and files documentation in the Trial Master File.
Manages study-specific training, system access, and supplies, while supporting team communications and vendor coordination.
Precision for Medicine is a Clinical Research Organization specializing in precision medicine, combining novel trial designs, operational expertise, and advanced biomarker analytics to advance oncology and rare disease treatments. The company fosters a collaborative, detail-oriented culture with a focus on professional growth and teamwork.
Lead quality assurance activities to support patient safety and pharmacovigilance compliance across global operations.
Plan, conduct, and manage pharmacovigilance audits, CAPA programs, and regulatory inspection readiness activities.
Collaborate with cross-functional teams including clinical development, regulatory affairs, and medical affairs to maintain robust quality systems.
This company is a science-driven healthcare organization focused on pharmacovigilance and patient safety. They operate in a collaborative, global environment committed to operational excellence and meaningful healthcare impact.
Coordinate day-to-day clinical trial operations remotely, ensuring compliance with protocols and regulations.
Support remote patient visits including scheduling, documentation, and follow-up.
Maintain accurate data entry in EDC/CTMS systems and assist with regulatory documentation.
UniTriTeam is a global leader in providing operational, administrative, and technology support to clinical research sites. They have a mission-driven, supportive, and inclusive team culture.
Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.