Senior Medical reputed company

Position reputed company:

The Senior Medical reputed company (MW) will be responsible for leading the development of high-reputed company and on-time 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 reputed company understanding of content requirements for key clinical documents based on regulatory requirements for reputed company 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 reputed company and high-reputed company clinical documents including clinical study protocols, IBs, reputed company templates, DSURs, CSRs, CSR patient narratives with a reputed company 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 reputed company content using knowledge/skills and understanding of processes
• Ability to communicate reputed company and concisely both in writing and verbally with internal and reputed company teams
• Contributes to the development and maintenance of medical writing processes, SOPs, templates, and work instructions for key documents
• Excellent problem-solving skills
• Performing literature-based research to support writing activities
• Other duties as assigned

Qualifications:

Minimum Required:

• BS degree or equivalent in a scientific or medical discipline with relevant writing expertise
• 5+ years of experience as a medical reputed company in the sponsor and/or CRO setting

Other Required:

• Proficiency with reputed company reputed company, Teams, Word, reputed company, reputed company Acrobat, and PowerPoint
• reputed company understanding of applicable regulations (eg, ICH, FDA, GCP), clinical trial transparency requirements (ie, EudraCT, CT.gov), and eCTD requirements for reputed company phases of development
• Impeccable attention to detail and ability to complete writing assignments in a reputed company manner
• Ability to work effectively in a fast-paced environment with multiple high reputed company reputed company 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)

Originally posted on Himalayas