Modern MedEd
Overview
The Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.
Responsibilities
Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
Facilitate comment resolution and adjudication with authors, reviewers, and project teams
Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high-quality medical writing deliverables
All other duties as assigned
Experience, Education and Specialized Knowledge and Skills
BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
Minimum of 10+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents
Knowledge of oncology disease areas preferred
Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
Excellent attention to detail, multitasking, prioritization, and flexibility
Excellent communication skills with proven ability to interact in a cross-functional environment
Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
Proficiency in use of MS Office applications, Adobe Acrobat, electronic document management systems, and templates
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal direction
Ability to think strategically, be resourceful, and lead with minimal direction
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Responsibilities
Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
Facilitate comment resolution and adjudication with authors, reviewers, and project teams
Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high-quality medical writing deliverables
All other duties as assigned
Experience, Education and Specialized Knowledge and Skills
BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
Minimum of 10+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents
Knowledge of oncology disease areas preferred
Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
Excellent attention to detail, multitasking, prioritization, and flexibility
Excellent communication skills with proven ability to interact in a cross-functional environment
Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
Proficiency in use of MS Office applications, Adobe Acrobat, electronic document management systems, and templates
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal direction
Ability to think strategically, be resourceful, and lead with minimal direction
#J-18808-Ljbffr