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.
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.
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.
Manage regulatory activities for complex submissions across EU, GCC, and Australian markets.
Conduct regulatory research, gap analyses, and prepare submission components.
Provide regulatory expertise within multidisciplinary project teams and support business development.
The company provides regulatory consulting services for healthcare products, focusing on global markets. It fosters a collaborative, inclusive culture with opportunities for career development and meaningful impact.
Manage complex regulatory activities related to active pharmaceutical ingredients, including DIFA/DMF processes and lifecycle management.
Provide strategic guidance and risk management support for API documentation and supplier qualification.
Collaborate with multidisciplinary teams and external partners to ensure regulatory compliance and operational excellence.
The partner company is a player in the pharmaceutical industry, focusing on regulatory affairs and lifecycle management of innovative products. The team size and culture are not specified, but the role emphasizes collaboration, continuous improvement, and remote work based in Brazil.
Lead content development for multiple projects, ensuring high quality and adherence to regulatory guidelines.
Collaborate with internal teams and external stakeholders to develop strategic medical communications.
Supervise medical writers and contribute to new business proposals and pitch meetings.
PRECISION AQ is a top payer marketing agency that supports global pharmaceutical and life sciences clients in achieving commercial excellence. We are a specialized agency with a focus on improving market access, fostering a collaborative and detail-oriented culture.
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.
Provide technical writing support for safety, epidemiology, registry, and risk management program operations.
Develop, revise, and finalize program reports, including Knowledge, Attitudes, and Behavior (KAB) survey outcome reports.
Collaborate directly with program operations teams to understand requirements and deliver high-quality documentation.
Jobgether uses AI-powered matching to connect candidates with hiring companies for job applications. They operate as a partner company managing applications and next steps for various positions.
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 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.
Develop high-quality, evidence-based medical content for healthcare professionals that supports clinical integrity and commercial objectives.
Translate complex scientific information into clear, compelling communications across print and digital formats.
Collaborate with cross-functional teams including medical, legal, and design to manage multiple projects and meet timelines.
Montu is Australia's largest healthtech business focusing on alternative healthcare, supporting patients, doctors, and pharmacies. Founded in 2019, Montu has been recognized as Australia's fastest-growing tech company with a driven and results-focused culture.
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.
Create bioanalytical reports, plans, and submission documents in support of internal projects and regulatory preclinical/clinical studies.
Extract and format data from multiple lab systems for integration into reports using Microsoft Office.
Ensure documentation complies with FDA, GxP, EMA, and other regulatory guidelines.
BioAgilytix provides best-in-class bioanalytical services to support new medicine breakthroughs. They have a team of highly experienced scientists and professionals, are growing, and are committed to being solution-oriented and deadline-driven.
Build and maintain scientific relationships with healthcare professionals and medical experts.
Gather and communicate medical insights to inform research and strategy.
Collaborate with cross-functional teams to support evidence-based discussions and healthcare initiatives.
The company is a healthcare organization focused on advancing innovative therapies and improving patient outcomes. While the specific size is not disclosed, the culture is collaborative, inclusive, and supportive of professional growth.
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.
Coordinate project communications, schedules, deadlines, and client correspondence.
Draft, edit, proofread, and format client-facing documents and presentations.
Manage project files, document libraries, and version control.
This company supports consulting engagements by ensuring projects run smoothly through strong organization and coordination. It fosters a collaborative remote environment focused on quality and innovation.
Oversee day-to-day management of third-party vendors throughout clinical study lifecycle.
Develop and implement vendor oversight plans and monitor performance through KPIs and governance meetings.
Facilitate cross-functional collaboration to resolve issues and ensure compliance with GCP and regulatory requirements.
The company is a clinical research organization that manages clinical trials and third-party vendors. The team size is not specified, but the culture is collaborative and quality-focused.
Analyze regulatory frameworks and licensing requirements across multiple jurisdictions.
Translate complex regulatory requests into structured compliance analyses and client deliverables.
Collaborate with engineering and legal teams to develop scalable compliance workflows and knowledge assets.
Our partner is a technology company focused on compliance and digital assets. They operate in a collaborative, international, and fully remote environment with a multidisciplinary team.
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.