Sr Medical Writer, Redaction; Clinical Trial Transparency
Syneos Health/ inVentiv Health Commercial LLC
80.6K a year
Behavioral Health Market Context
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Benefits
Company car or car allowanceHealth benefits:Medical, dental, and visionCompany match 401(k)Eligibility to participate in Employee Stock Purchase PlanEligibility to earn commissions/bonuses based on company and individual performanceFlexible paid time off (PTO) and sick timeSalary Range: $80,600.00 - $
Job Description
Position: Sr Medical Writer, Redaction (Clinical Trial Transparency)
Sr Medical Writer, Redaction (Clinical Trial Transparency)
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
Job Responsibilities
• Authoring and quality assurance of project activities
• Execute project-specific activities with high quality and within defined timelines according to standard processes and operating procedures.
• Mark, QC, review, and/or edit pertinent documents such as:
• Clinical study documents or any other documents for regulatory submission (e.g., clinical study reports, patient narratives, clinical summaries) for regulations including EMA policy 0070, Health Canada PRCI, EUCTR regulation, and final rule-NIH.
• Protocol and results summaries to support clinical trial disclosure commitments.
• Systematically perform quality‑control checks of documents prepared by colleagues against a pre‑specified checklist generated in the project or SOP.
• Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs.
• Ensure compliance with client processes.
• Complete internal and client‑specific training.
• Assist in mentoring and training of team members depending on project requirements.
Benefits
• Company car or car allowance.
• Health benefits:
medical, dental, and vision.
• Company match 401(k).
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonuses based on company and individual performance.
• Flexible paid time off (PTO) and sick time.
Salary Range: $80,600.00 - $
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered, so qualifications of incumbents may differ from those listed in the Job Description. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations.
The company complies with all applicable federal, state, and municipal paid sick time requirements.
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Sr Medical Writer, Redaction (Clinical Trial Transparency)
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
Job Responsibilities
• Authoring and quality assurance of project activities
• Execute project-specific activities with high quality and within defined timelines according to standard processes and operating procedures.
• Mark, QC, review, and/or edit pertinent documents such as:
• Clinical study documents or any other documents for regulatory submission (e.g., clinical study reports, patient narratives, clinical summaries) for regulations including EMA policy 0070, Health Canada PRCI, EUCTR regulation, and final rule-NIH.
• Protocol and results summaries to support clinical trial disclosure commitments.
• Systematically perform quality‑control checks of documents prepared by colleagues against a pre‑specified checklist generated in the project or SOP.
• Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs.
• Ensure compliance with client processes.
• Complete internal and client‑specific training.
• Assist in mentoring and training of team members depending on project requirements.
Benefits
• Company car or car allowance.
• Health benefits:
medical, dental, and vision.
• Company match 401(k).
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonuses based on company and individual performance.
• Flexible paid time off (PTO) and sick time.
Salary Range: $80,600.00 - $
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered, so qualifications of incumbents may differ from those listed in the Job Description. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations.
The company complies with all applicable federal, state, and municipal paid sick time requirements.
#J-18808-Ljbffr
Responsibilities
- •Authoring and quality assurance of project activities
- •Execute project-specific activities with high quality and within defined timelines according to standard processes and operating procedures
- •Mark, QC, review, and/or edit pertinent documents such as:
- •Clinical study documents or any other documents for regulatory submission (e.g., clinical study reports, patient narratives, clinical summaries) for regulations including EMA policy 0070, Health Canada PRCI, EUCTR regulation, and final rule-NIH
- •Protocol and results summaries to support clinical trial disclosure commitments
- •Systematically perform quality‑control checks of documents prepared by colleagues against a pre‑specified checklist generated in the project or SOP
- •Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs
- •Ensure compliance with client processes
- •Complete internal and client‑specific training
- •Assist in mentoring and training of team members depending on project requirements
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