Contract Medical Writer Job Opening
Contract Medical Writer
Katalyst Healthcares & Life Sciences
• New Brunswick, New Jersey
— Contract
Category: Technical Writer
Roles and Responsibilities:
Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs
Assists in writing Integrated Summaries of Safety and Efficacy (ISS and Client), New Drug Applications (NDAs) and other regulatory documents necessary for regulatory submission
Writes and develops manuscripts and/or posters for publication
Creates in-text tables and word processing
Compiles document appendices, attachments, etc.
Reviews associate medical writer generated documents and provides constructive feedback (mentoring)
Assists in the review of draft case report forms (CRFs), statistical analysis plans (SAPs), and in blinded data listing reviews prior to database lock and provides feedback to the team when appropriate
Conducts background research as necessary for each assigned project, including literature searches
Works on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and sponsors
Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
Ensures timeline adherence for each assigned project
Facilitates a team approach for each assigned project
Provides project status updates on a regular basis
Carries out contractual obligations for each assigned project based on the sponsor proposal
Job Skills:
Requires excellent typing skills, ability to use templates, and the ability to create and manage large electronic files and documents
Requires analytical skills and a working knowledge of medical terminology.
Requires strong written and verbal skills in English
Requires excellent communication skills
Works independently and in a team environment
Effectively plans, schedules, and coordinates writing assignments
Demonstrates the ability to facilitate a project team meeting with internal and external team members
Education and Experience:
Two years of experience in medical/technical writing (Medical Device)
Bachelor's degree in the medical sciences, journalism, or English (MS or PhD preferred)
Writes, edits, and performs quality control (QC) reviews for CSRs, protocols, and IBs
Assists in writing Integrated Summaries of Safety and Efficacy (ISS and Client), New Drug Applications (NDAs) and other regulatory documents necessary for regulatory submission
Writes and develops manuscripts and/or posters for publication
Creates in-text tables and word processing
Compiles document appendices, attachments, etc.
Reviews associate medical writer generated documents and provides constructive feedback (mentoring)
Assists in the review of draft case report forms (CRFs), statistical analysis plans (SAPs), and in blinded data listing reviews prior to database lock and provides feedback to the team when appropriate
Conducts background research as necessary for each assigned project, including literature searches
Works on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and sponsors
Participates in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
Ensures timeline adherence for each assigned project
Facilitates a team approach for each assigned project
Provides project status updates on a regular basis
Carries out contractual obligations for each assigned project based on the sponsor proposal
Job Skills:
Requires excellent typing skills, ability to use templates, and the ability to create and manage large electronic files and documents
Requires analytical skills and a working knowledge of medical terminology.
Requires strong written and verbal skills in English
Requires excellent communication skills
Works independently and in a team environment
Effectively plans, schedules, and coordinates writing assignments
Demonstrates the ability to facilitate a project team meeting with internal and external team members
Education and Experience:
Two years of experience in medical/technical writing (Medical Device)
Bachelor's degree in the medical sciences, journalism, or English (MS or PhD preferred)