Principal Medical Writer at IQVIA Durham, NC

Overview

Principal Medical Writer job ham, NC.

Job Overview: Acts as Lead Medical Writer on any type of writing project, including projects with multiple deliverables/components. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs senior review of all types of medical writing deliverables. Provides feedback and guidance to more junior staff. Negotiates timelines and discusses/resolves customer comments.

Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

• Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
• Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
• Use experience and initiative to tackle new/unusual document types and customer requirements.
• Chair meetings. Able to act as point of contact for escalations and resolve conflict.
• Participate in bid defense meetings and discussions.
• May design training materials and input into generic training plans for staff.
• Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team.
• May propose, plan and deliver general training on Medical Writing to other IQVIA groups and externally, as appropriate.
• May act as Project Manager for a small series of Medical Writing projects, that may involve elements of other functions.
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Independently propose, review and approve budgets and assumptions for a range of project types within remit.
• May take on a partnership lead role.
• Likely to represent region or site on a Medical Writing initiative or cross-functional initiative.
• May draft new Medical Writing Standard Operating Procedures (SOPs) for review and act as reviewer for Medical Writing SOPs, as assigned and appropriate.

• Bachelor's Degree (or experience equivalent) in life sciences related discipline or related field
• Master's Degree (or experience equivalent) in life sciences related discipline or related field
• Ph.D. (or experience equivalent) in life sciences related discipline or related field
• Typically requires at least 7 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 and ability to identify deficiencies, errors, and inconsistencies in 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 and to identify deficiencies, errors, and inconsistencies in statistical output
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges.
• Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements.
• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• Confident and effective communication and negotiation skills with customers and project managers.
• Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
• Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
• Demonstrated abilities in collaboration with others and independent thought.
• Demonstrated ability to influence others without having official authority.
• Demonstrates good judgement in requesting input from senior staff.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers at a senior level.
• Experienced and effective in providing feedback and guidance to more junior staff.
• Ability to effectively manage multiple tasks and projects. Decisive amongst competing priorities.
• Confident in raising and discussing sensitive topics without management intervention.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers. Confidence in appropriately challenging the customer when document quality or timelines are at risk.
• Must be computer literate.

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