New Jersey, United States · Hybrid
Job Description Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex…
Skills: Medical Writing, Clinical Regulatory Documentation, Project Management, Cross-functional Collaboration, Clinical Study Reports
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Lead the planning and preparation of high-quality clinical regulatory documents by partnering cross-functionally with client teams. Manage document execution, including timeline creation, stakeholder coordination, and the resolution of review feedback.
Requires over 5 years of medical writing experience in the CRO, biotech, or pharmaceutical field with a bachelor's degree or higher. Expertise in ICH/US regulatory requirements and experience with oncology, infectious disease, or vaccines is desired.
Job Description
Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.
Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.
Location: Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.
Essential Duties & Responsibilities
Requirements
For further information or to apply, please reach out to [email protected].
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Synterex participates in the Department of Defense’s SkillBridge program. For more information, please visit www.synterex.com/fellowships-internships.
Synterex is a clinical and regulatory consulting firm specializing in agile methodology and AI-driven technologies.
Synterex is a woman-owned (WBENC), disability-owned (DOBE) clinical and regulatory consulting firm specializing in agile methodology, automation, and artificial intelligence (AI)-driven technologies. We provide clinical writing and development solutions, helping clients deliver important new therapies to patients in an expedient manner. Synterex is the home of AgileWriter.ai®, an AI-enabled authoring platform for clinical documentation that prioritizes accessibility. AgileWriter can input a variety of source formats and craft documents in natural language, trimming up to 50% of time from the standard manual process of document creation and management. It also ensures readability requirements are met and adheres to W3C Authoring Tool Accessibility Guidelines (ATAG), maximizing the intersection between technology and accessibility and allowing medical communicators to focus on getting therapies to patients sooner. Synterex also offers top-tier IT services, driving operational excellence through superior support in project management, client communication, and technical execution. Our IT services include environment migrations, health checks, systems deployments and support, and more!
Offices: -, Dedham, MA 02026, US
Synterex is a clinical and regulatory consulting firm specializing in agile methodology and AI-driven technologies.
Synterex is a woman-owned (WBENC), disability-owned (DOBE) clinical and regulatory consulting firm specializing in agile methodology, automation, and artificial intelligence (AI)-driven technologies. We provide clinical writing and development solutions, helping clients deliver important new therapies to patients in an expedient manner. Synterex is the home of AgileWriter.ai®, an AI-enabled authoring platform for clinical documentation that prioritizes accessibility. AgileWriter can input a variety of source formats and craft documents in natural language, trimming up to 50% of time from the standard manual process of document creation and management. It also ensures readability requirements are met and adheres to W3C Authoring Tool Accessibility Guidelines (ATAG), maximizing the intersection between technology and accessibility and allowing medical communicators to focus on getting therapies to patients sooner. Synterex also offers top-tier IT services, driving operational excellence through superior support in project management, client communication, and technical execution. Our IT services include environment migrations, health checks, systems deployments and support, and more!
Offices: -, Dedham, MA 02026, US
