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Remote Medical writer (east coast0 (Science & Biotech)
Remote, NC 27601
Recruited by: Ali Henderson | Senior Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: Simulstat Inc
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: May 01, 2021
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Job Description

Remote, contract – 6 months with potential to extend. Must be able to work Eastern Time Zone hours.
Coordination of medical writing activities for Medical Writing projects. Independently write, edit, and compile clinical/regulatory documents specifically protocol development for all phase clinical trials, clinical study reports, support NDA/IND submissions, investigator related documents as well as reports for safety and epidemiology projects such as REMS and KABS.
Requirements:
• Bachelor’s degree in biological sciences or equivalent
• At least 8+ years’ experience in medical writing within the pharmaceutical/CRO industry
• Advanced word processing skills (Microsoft Word) including proficiency with tables
• Strong organization and prioritization skills
• Attention to detail/high degree of accuracy
• Self-starter; willing to ask lots of questions and learn new things!
• Ability to clearly and effectively communicate and interact with clients
• Strong analytical, problem-solving, and data interpretation skills
• Good communication skills
• Good interpersonal skills
• Ability to work both independently and as a part of a project team
• Exposure and familiarity with relevant ICH and FDA guidelines
• Understanding of templates and styles
Specific Job Duties:
• Preparation of departmental deliverables, such as clinical protocol development (required), observational/late stage reporting experience specifically in writing KABs/REMS reports, regulatory clinical study reports for all phases, IND, NDA and CTD summary documents, and manuscripts for publication
• Represent Medical Writing on client project teams for project planning, timeline development, and resource management
• Knowledge of the utilization and implementation of sponsor related style guides
• Participate in proposal preparation and resource allocation
• Proactively manage timelines for medical writing deliverables
• Represent Medical Writing at bid defenses and internal meetings
• Assist in the development of key messaging and operational procedures
• Ability to review and understand client report templates and style guides.
• Coordination/consultation with other departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects
• Develop/maintain medical writing SOPsD
• Perform quality control and peer reviews of documents and assess compliance with regulatory requirements, clients requests, and SOPs
• Inform Medical Writing Department head of potential problems/challenges
• Conduct comment resolution meetings
• Other duties as assigned