Senior Medical Writer
Senior Medical Writer
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Job Description
Position Summary:
The Senior Medical Writer (MW) will be responsible for leading the development of highquality and ontime clinical study documents. Specific responsibilities include clinical document planning writing editing/formatting and performing QC review. Develops documents in compliance with Precision MW Style Guide Precision SOPs applicable regulatory guidelines (ie ICH FDA GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.
Essential functions of the job include but are not limited to:
- Planning writing editing formatting and QC review of timely and highquality clinical documents including clinical study protocols IBs ICF templates DSURs CSRs CSR patient narratives with a clear understanding of content requirements based on regulatory guidances
- Ensures smooth and effective document management from start to finish (ie from template to final approved version) in collaboration with Sponsor external vendors and/or internal Precision project teams/departments
- Ability to independently formulate key messages from clinical study data
- Ability to author complex content using knowledge/skills and understanding of processes
- Ability to communicate clearly and concisely both in writing and verbally with internal and client teams
- Contributes to the development and maintenance of medical writing processes SOPs templates and work instructions for key documents
- Excellent problemsolving skills performing literaturebased research to support writing activities
Qualifications: Minimum Required:
- BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
- 5 years of experience as a medical writer in the sponsor and/or CRO setting
Other Required:
- Proficiency with Microsoft Windows Teams Word Excel Adobe Acrobat and PowerPoint
- Clear understanding of applicable regulations (eg ICH FDA GCP) clinical trial transparency requirements (ie EudraCT CT) and eCTD requirements for all phases of development Impeccable attention to detail and ability to complete writing assignments in a timely manner
- Ability to work effectively in a fastpaced environment with multiple high priority projects with no instruction on routine work and minimal instruction on new assignments
Preferred:
- Advanced degree (MS/PhD)
- Oncology and/or rare disease experience (especially protocol and CSR development.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status or other characteristics protected by law. 2020 Precision Medicine Group LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying you may contact Precision Medicine Group at .
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Required Experience:
Senior IC
Employment Type
Full Time
