MedFocus Senior Medical Writer in Massachusetts
The Senior Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug development by writing, organizing, analyzing, and interpreting scientific and statistical data. Such documents include clinical study reports, study protocols, investigator’s brochures, manuscripts, abstracts and posters Responsibilities
Write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, summary documents, and other IND/CTA or global regulatory submission documents.
Actively support and participate in clinical project teams with review and interpretation of clinical study data and addressing questions from study team members. Determine the best approach to composing each document.
Complete documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
Participate in developing key messages for various clinical regulatory documents.
Responsible for the development and standardization of templates and related processes to support the medical writing needs of the organization.
Manage writing, editing, QC and publishing activities for assigned projects.
Ensure medical and scientific consistency between related documents or studies in a clinical program.
Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
Contribute to statistical output plan concerning organization and table layout for a specific document.
Provide input and support for advisory board meetings for clinical development programs
May assist in preparing grant applications
Assist in the developing SOPs and related procedures
Manage contract writers, as needed.
Prepare and submit abstracts and posters for scientific meetings
Prepare powerpoint presentations for internal as well as external presentations
Please send resume to firstname.lastname@example.org
BS/BSc/BA in a science or industry-related discipline
5 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting including global regulatory submission experience.
Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems and document management systems
Excellent writing skills and the ability to accurately and clearly present clinical data, strong verbal and interpersonal communication skills, and proficiency in MicroSoft Word required.
Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred.
Working knowledge of template use for document creation.
Min Salary: $0.00
Max Salary: $0.00