Principal Medical Writer, FSP

IQVIA Argentina; Durham (NC); On-site; USD 97,000 - 163,000; Full time

Job summary

An established industry player is seeking a Lead Medical Writer to join their dynamic team. In this pivotal role, you will prepare various clinical documents, ensuring compliance with regulations and clarity of key messages. You will leverage your extensive experience in medical writing to independently manage complex projects, drive timelines, and contribute to the success of innovative medical treatments. This position offers a unique opportunity to impact patient outcomes and collaborate with talented professionals in a supportive environment. If you are passionate about medical writing and thrive in a fast-paced setting, this role is perfect for you.

Qualifications

• 8+ years of experience in medical writing or related field.
• Strong knowledge of Good Clinical Practice (GCP).

Responsibilities

• Writes clear and concise clinical submission documents.
• Ensures documents meet regulations and key messages.
• Drives document preparation process and manages timelines.

Skills

Medical Writing

Regulatory Knowledge

Statistical Analysis

Clinical Study Reports

Document Preparation

Education

Bachelor's Degree in Life Sciences

Master's or PhD in Life Sciences

Job description

Job Overview:

As a Lead Medical Writer on most types of writing projects. You will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Perform Senior Review of straightforward medical writing deliverables. Negotiate timelines and discusses/resolves customer comments. Provide written and verbal feedback to junior staff, and to customers when appropriate.Keep 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.

Responsibilities:

• Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.
• Contributes to project plan concerning timelines as well as organization and table layout for a specific document.
• Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
• Review and edit documents for consistency, progression, structure, and grammar.
• Review statistical analysis plans and incorporate into clinical study reports or submission documents, as applicable.
• Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.
• Participate in team and client meetings as requested. Deliverables above plus able to work independently on a range of complex clinical documents
• Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently
• Resolves complex problems independently

Education and Experience required:

• 8+ years of experience in medical writing or related field
• Required - Bachelors Degree in Life Sciences or related field
• Preferred - Masters or PhD in Life Sciences or related field

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $97,700.00 - $162,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.