Medical Writer, Project Lead
Ipsen
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $143,250 - $210,100 per year
Job Level
About the role
- Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules.
- Lead Writing/Editing complex Clinical Dossiers/Safety Reports.
- Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier.
- Plan and create timelines to produce assigned documents.
- Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team.
- Actively contribute to best practices and continuous improvement within the therapeutic Area.
- Represent the group in functional and cross functional initiatives/projects when required.
- Network and share best practices to ensure efficiency and consistency across product teams.
- Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work.
- Adhere to the quality control process and ensure all work produced has gone through the correct internal review process.
- Maintain a working knowledge of pharmaceutical industry standards and compliance.
- Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested.
- Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget.
Requirements
- 5+ years of experience in clinical and regulatory medical writing within pharmaceutical, biotechnology, academic, or CRO settings.
- Working knowledge of ICH and US regulatory requirements.
- Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
- Proficient in using Microsoft Office programmes (e.g. PowerPoint, Excel, etc.).
- A keen interest in working and developing scientific expertise across a range of therapy areas.
- Flexible approach to working, with the ability to reprioritize and work under pressure when needed.
- Excellent time management skills and demonstrated ability to forecast and manage workload.
- Experience as a clinical/regulatory/safety Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts.
- Able to manage coordination responsibilities beyond writing individual documents, e.g., timelines, reviews and submissions.
Benefits
- 401(k) with company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Short-term disability insurance
- Long-term disability insurance
- Flexible spending accounts
- Parental leave
- Paid time off
- Discretionary winter shutdown
- Well-being allowance
- Commuter benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical writingregulatory writingmedical writingclinical study reportsprotocolsinvestigator brochuressafety reportsbiostatisticspharmacokineticsstudy design
Soft Skills
time managementflexibilityability to work under pressureforecasting workloadnetworkingbest practices contributionadministrative skillscommunicationteam collaborationproject management