3 Core Writing Jobs

Weare seeking a highly experienced Senior Medical Writer to lead the clear and accurate completion of medical writing deliverables. This role involves managing all medical writing activities for individual studies, ensuring scientific information is presented with clarity and accuracy. The ideal candidate will have a strong background in the biopharmaceutical industry, a deep understanding of regulatory standards, and proven experience in writing a variety of key documents, including Clinical Study Reports (CSRs), Investigator Brochures (IBs), and Protocols . Roles & Responsibilities Leadership & Project Management: Lead and oversee the completion of all medical writing deliverables. Manage medical writing activities for individual studies with minimal supervision, coordinating across various departments. Mentor and lead less-experienced medical writers on complex projects. Work within budget specifications for all assigned projects. Content Creation & Compliance: Complete a wide range of documents, including clinical study protocols , amendments, clinical study reports, patient narratives, and investigator brochures. Adhere to established regulatory standards, including ICH E3 guidelines , company SOPs, and client-specific requirements. Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency. Collaboration & Quality Assurance: Coordinate quality and editorial reviews to ensure all documents meet high standards. Act as a peer reviewer to ensure scientific content, clarity, and proper format. Build strong working relationships with clients and peers in data management, biostatistics, and regulatory affairs. Problem-Solving & Expertise: Perform online clinical literature searches and comply with copyright requirements. Identify and propose solutions to resolve issues, providing technical support and consultation to teams. Develop and maintain deep expertise on key industry topics and regulatory requirements. Preferred Candidate Profile Education: A Bachelor's degree in a relevant discipline; a graduate degree is preferred. Experience: Professional experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry is required. Proven experience writing relevant document types, including CSRs, IBs, and Protocols . Skills: Strong understanding of FDA and ICH regulations is required. Extensive knowledge of English grammar and the ability to communicate clearly. Strong familiarity with the AMA Manual of Style .

We are seeking a Medical Writer II with a strong background in CSR (Clinical Study Report) safety narratives writing . This role is responsible for compiling, writing, and editing a variety of medical writing deliverables to present scientific information clearly and accurately. The ideal candidate will work both independently and collaboratively, ensuring all documents adhere to established regulatory standards and best practices. Roles & Responsibilities Core Writing & Documentation: Compile, write, edit, and coordinate a wide range of medical writing deliverables with a primary focus on CSR safety narratives (authoring, addressing review comments, and collaborating with teams). Complete documents such as clinical study protocols , clinical study reports , patient narratives, investigator brochures, and periodic safety update reports. Review statistical analysis plans and table/figure/listing specifications to ensure content and formatting are consistent and appropriate. Compliance & Quality Control: Adhere to established regulatory standards, including ICH E3 guidelines , and internal SOPs. Coordinate quality and editorial reviews and act as a peer reviewer for the internal team. Lead document reviews and resolve comments from clients to ensure the final deliverable meets all requirements. Collaboration & Project Management: Build and maintain good working relationships with clients, department heads, and peers to produce high-quality deliverables. Identify and propose solutions to resolve document-related issues, escalating as needed. Stay aware of project budget specifications and manage work within the allocated hours. Mentorship & Professional Development: Mentor less-experienced medical writers on projects as necessary. Maintain a strong working knowledge of the drug development process , regulatory guidelines, and industry standards. Perform online clinical literature searches and comply with copyright requirements. Qualifications A Bachelor's degree in a relevant discipline with a graduate degree preferred. At least professional experience in science, technical, or medical writing. Experience in the biopharmaceutical, device, or contract research organization industry is a plus. Familiarity with FDA and ICH regulations and AMA Manual of Style . Extensive knowledge of English grammar and the ability to communicate clearly.

We are seeking a Medical Writer II with a strong background in QC (Quality Control) of regulatory documents . This role involves compiling, writing, and editing a variety of medical writing deliverables to ensure scientific information is presented clearly and accurately. The ideal candidate will have hands-on experience in the biopharmaceutical industry, a keen eye for detail, and a deep understanding of regulatory standards and guidelines. Roles & Responsibilities Quality Control & Compliance: Perform QC of regulatory documents , including protocols, CSRs, and IBs. Adhere to established regulatory standards, such as ICH E3 guidelines , and company SOPs. Coordinate quality and editorial reviews to ensure scientific content, clarity, and overall consistency. Act as a peer reviewer to ensure proper formatting and scientific accuracy. Content Creation & Documentation: Compile, write, and edit a wide range of documents, including clinical study protocols, clinical study reports, patient narratives, investigator brochures, and periodic safety update reports. Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency. Collaboration & Project Management: Lead document reviews, resolve comments from clients, and ensure appropriate management of source documentation. Interact and build good working relationships with clients, department heads, and peers. Identify and propose solutions to resolve document issues, escalating as needed. Be aware of project budget specifications and work within the budgeted hours. Mentorship & Professional Development: Mentor less-experienced medical writers on projects as needed. Maintain a strong working knowledge of the drug development process , regulatory guidelines, and best practices. Perform online clinical literature searches and comply with copyright requirements. What We're Looking For A Bachelor's degree in a relevant discipline with a graduate degree preferred. Professional experience in science, technical, or medical writing. Experience in QC of regulatory documents is a must. Experience working in the biopharmaceutical, device, or contract research organization industry is preferred. Familiarity with FDA and ICH regulations and AMA Manual of Style . Extensive knowledge of English grammar and the ability to communicate clearly.