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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing, particularly in preparing clinical study reports and protocols, while effectively leading projects and mentoring junior staff. Possesses strong communication skills and a thorough understanding of regulatory requirements and statistical methods in clinical trials.
Highest-signal resume keywords
Lead Medical WriterClinical Study Reports (CSRs)Statistical Analysis Plan ReviewExcellent Written and Oral Communication SkillsAttention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical WritingClinical Study ReportsProtocolsStatistical MethodsTechnical WritingRegulatory KnowledgeDocument PreparationProject ManagementReviewing DeliverablesTraining and Development
Soft Skills
Communication SkillsNegotiation SkillsOrganizational SkillsFeedback ProvisionTeam Leadership
Industry Keywords
IQVIA Standard Operating ProceduresLife SciencesClinical TrialsGrammatical SkillsAttention to Accuracy
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