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For Companies At a Glance
- Tasks: Lead medical writing projects, ensuring quality and adherence to timelines.
- Company: Join IQVIA, a global leader in clinical research and healthcare intelligence.
- Benefits: Enjoy flexible work options, professional development, and a collaborative culture.
- Why this job: Make a real impact in healthcare while growing your skills in a supportive environment.
- Qualifications: Bachelor's degree required; advanced degrees preferred with 5+ years in regulatory writing.
- Other info: Opportunity to mentor junior staff and lead complex projects.
The predicted salary is between 48000 - 72000 £ per year.
Job Overview
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 as well as to the agreed timelines. 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, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
Essential Functions
• 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.
• Lead meetings on more challenging topics independently.
• May present on standard Medical Writing processes at full-service bid defense meetings.
• Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups.
• May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.
• May take on a small customer lead role or assist an established partnership lead in their role.
• May represent region or site on a Medical Writing initiative or cross-functional initiative.
• Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit.
Qualifications, Experience and Skills
• Bachelor\’s Degree n life sciences related discipline or related field required
• Master\’s Degree in life sciences related discipline or related fieldpreferred
• Ph.D. in life sciences related discipline or related field preferred
• Typically requires at least 5 years of highly relevant experience in regulatory writing and related competency levels.
• In-depth knowledge of the structural and content requirements of clinical study reports (CSR), protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
• 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.
• Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.
• 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.
• Able to deliver difficult messages in constructive manner.
• Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
• Demonstrated abilities in collaboration with others and independent thought.
• Demonstrates confidence and maturity in most routine medical writing situations.
• Demonstrates good judgement in requesting input from senior staff.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Ability to effectively manage multiple tasks and projects.
• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.
• Must be computer literate.
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
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Senior Medical Writer (Regulatory Writing) employer: IQVIA Argentina
Contact Detail:
IQVIA Argentina Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer (Regulatory Writing)
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in medical writing, especially those related to regulatory submissions. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the medical writing community, particularly those who have experience in regulatory writing. Attend industry conferences or webinars to make connections and learn about potential job openings that may not be advertised.
✨Tip Number 3
Prepare to discuss specific projects you've worked on that align with the responsibilities of a Senior Medical Writer. Be ready to share examples of how you've led writing projects, managed timelines, and collaborated with teams to achieve successful outcomes.
✨Tip Number 4
Showcase your mentoring skills by discussing any experience you have in training junior staff. Highlighting your ability to lead and develop others can set you apart as a candidate who not only excels in writing but also contributes to team growth.
We think you need these skills to ace Senior Medical Writer (Regulatory Writing)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory writing and medical writing. Emphasise your leadership roles, particularly in preparing clinical study reports and protocols, as well as any mentoring or training you've provided to junior staff.
Craft a Strong Cover Letter: In your cover letter, address how your skills align with the job requirements. Mention your understanding of Good Clinical Practice (GCP) and your ability to negotiate timelines and manage projects effectively. Use specific examples from your past experiences to demonstrate your capabilities.
Showcase Your Knowledge: Highlight your in-depth knowledge of drug development and medical writing regulations. Discuss your familiarity with statistical methods used in clinical trials and how you have applied this knowledge in your previous roles.
Proofread Your Application: Before submitting your application, thoroughly proofread all documents for grammatical accuracy and clarity. Attention to detail is crucial in medical writing, so ensure that your application reflects this quality.
How to prepare for a job interview at IQVIA Argentina
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing skills are paramount. Bring samples of your previous work to the interview and be prepared to discuss your writing process, how you ensure compliance with regulatory standards, and how you handle feedback.
✨Demonstrate Your Knowledge of Regulations
Familiarise yourself with Good Clinical Practice (GCP) and other relevant regulations. Be ready to discuss how you have applied this knowledge in past projects, particularly in preparing clinical study reports and protocols.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and how you manage timelines and customer expectations. Think of specific examples where you successfully navigated challenges in your writing projects.
✨Highlight Your Leadership Experience
Since the role involves mentoring junior staff and leading projects, be prepared to discuss your leadership style. Share experiences where you have trained others or led meetings, showcasing your ability to communicate effectively and inspire confidence.
