Medical Writer I

This role will support the our sponsors Immunoglobulins TA. I am looking for a junior level Medical Writer, based in the EST time zone. This individual would initially serve as a secondary writer, partnering with a lead writer in the EU to allow document work to span across two time zones. Once fully onboarded and familiar with our sponsors procedures, this individual could also serve as a document lead. Supported documents may include, but are not limited to protocols, CSRs, briefing books, investigator brochures, and CTD module 2 documents.

Key Roles and Responsibilities include:

• Planning and preparing high quality medical writing deliverables that support clinical development and meet regulatory requirements
• Developing medical writing project timelines
• Coordinating and managing the tasks, roles, responsibilities and timing of the authoring team and internal / external reviewers to facilitate document completion
• Formatting and editing documents to match the company required styles
• Maintaining awareness of potential delays, problems or gaps of information that exist in the team effort of document preparation in order to effectively manage the process.
• Coordinating the review, QC and assembly of medical writing deliverables.
• Responsible for building and maintaining collaborative relationships with cross-functional business partners to ensure an effective, efficient, productive and professional working relationship.
  
  

Requirements:

• An undergraduate degree in pharmacy, biological sciences or related disciplines is required
• Post-graduate qualifications desired
• Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry (minimum 1 year)
• Post-graduate studies or work experience in Immunology or Oncology preferred
• Excellent level of English language proficiency
• Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and templates
• A solid understanding of the Clinical Development Process, including the documents that are required at each stage of development
• Excellent organizational and time management skills
• Excellent written and oral communication skills
• Excellent interpersonal skills
• Strong attention to detail
• Ability to write clearly and logically
• Ability to work to deadlines while maintaining focus on details and quality.
• Demonstrated ability to work collaboratively; demonstrated negotiating skills and resourcefulness.
• Applies good judgement and demonstrates initiative
• An ability to analyze, interpret and communicate data accurately and concisely.
  
  

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 at https://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 $58,800.00 - $98,000.00. 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.