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About the role
Key responsibilities & impact- Acts as Lead Medical Writer on most types of writing projects
- Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements
- Performs Senior Review of straightforward medical writing deliverables
- Negotiates timelines and discusses/resolves customer comments
- Provides written and verbal feedback to junior staff, and to customers when appropriate
- Keeps abreast of current medical and/or technical writing/regulatory knowledge
- Take a leading role in preparing assigned documents
- Plan and organize workload for assigned projects and tasks
- Lead meetings on more challenging topics independently
- May assist in the training and development of junior staff
- May act as Project Manager for a more complex but single Medical Writing project
Requirements
What you’ll need- Bachelor's Degree in life sciences related discipline or related field
- Master's Degree in life sciences related discipline or related field
- Ph.D. in life sciences related discipline or related field
- Typically requires at least 3 years of highly relevant experience and related competency levels
- In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results
- Ability to effectively review a statistical analysis plan
- Significant experience as a lead writer in preparing CSRs and protocols
- Excellent written and oral communication skills including grammatical/technical writing skills
- Excellent attention to detail and accuracy.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Medical WritingClinical Study ReportsProtocolsStatistical MethodsTechnical WritingRegulatory KnowledgeDocument PreparationProject ManagementReviewing DeliverablesTraining and Development
Soft Skills
Communication SkillsNegotiation SkillsOrganizational SkillsFeedback ProvisionTeam Leadership
