Sign in

103924 - Medical Writer

Company:
inVentiv Health Clinical
Location:
Bernards, New Jersey, 07920, United States
Posted:
February 13, 2018
Description:

Job Description:

Writes Phase 2-3 clinical protocols and study reports with guidance from study team members and senior medical writing personnel; Organizes and leads meetings with study team members to determine timelines and processes for protocol and study report development. Liaises with QC department to ensure quality control of documents. Organizes and prepares cover sheets for report appendices.

Education:

• Minimum 2 years of experience with a Master’s of Science degree or equivalent or

• Minimum 5 years of experience with a Bachelor's degree or equivalent

Experience

• Medical writing experience required

• The position will be responsible for hands-on writing, coordination of document reviews, and document quality control (QC) for documents produced by other writers.

• Documents must be of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and adherence to regulatory requirements and company guidelines/styles/processes.

• In addition, the position will also edit NDA submission documents, edit SOPs, and interact with and support CRO medical writers.

• This position has basic knowledge of clinical development and clinical, medical, and regulatory writing.

Responsibilities

• Edits Phase 2-3 clinical protocols and study reports, NDA submission documents, and SOPs; Ensures key messages are clear and consistent; Adheres to house style guide for formatting and usage

• Manage/Assist documents through the review process (coordinating document review meetings, collate and reconcile comments from various functional groups) and the approval process; Assist document approvers with using Documentum to provide electronic signatures

• Writes clinical sections of investigator brochures and assembles nonclinical and CMC sections; Organizes and leads meetings with project team members to determine timelines and processes for IB development; Uses data from clinical study reports to update clinical sections of IB; Interacts with colleagues in Asia regarding updates to nonclinical section; Liaises with QC department to ensure quality control of IB

• Provide independent document quality control services for documents on which the writer has no other role; Check electronically published CSRs for completeness (appendices and required signatures present) and adherence to company’s electronic publishing standards before archiving

• Interacts with and supports CRO medical writers by communicating company standards, processes, templates, timelines, etc.