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For Companies At a Glance
- Tasks: Lead medical writing projects, manage timelines, and communicate with clients globally.
- Company: Join IQVIA, a global leader in clinical research and healthcare innovation.
- Benefits: Enjoy a dynamic work environment with opportunities for remote work and professional growth.
- Why this job: Make an impact in healthcare while developing your skills in a collaborative culture.
- Qualifications: Bachelor's degree in life sciences required; 8+ years of relevant experience preferred.
- Other info: Diversity is valued; we are an equal opportunity employer.
The predicted salary is between 48000 - 72000 £ per year.
Acts as Lead Medical Writer on various writing projects, advising others on document types. Capable of managing customer accounts, presenting, discussing, and answering questions about Medical Writing capabilities globally. Performs senior review of all medical writing deliverables, providing feedback, guidance, and identifying training needs. Communicates medical writing topics to broad audiences and manages timelines and customer feedback. Keeps updated on current medical and technical writing, regulatory knowledge, GCP, and advances in drug development and medical writing.
Essential Functions
- Lead preparation of assigned documents, confirming scope, templates, specifications, negotiating timelines, organizing reviews, and communicating with customers.
- Plan and organize workload, identify project needs, track timelines, and implement customer requests.
- Address new or unusual document types and customer requirements using experience and initiative.
- Chair meetings and resolve conflicts using negotiation skills.
- Participate in bid defense meetings and discussions.
- Design training materials, contribute to training plans, and deliver knowledge-sharing sessions or workshops.
- Manage large Medical Writing projects, coordinating activities across regions and functions, focusing on efficiency, consistency, budget, and customer liaison.
- Monitor and forecast project budgets and hours, proposing and approving budgets within remit.
- Lead or participate in global Medical Writing initiatives and represent Medical Writing in cross-functional SOP reviews, suggesting process improvements.
Qualifications
- Bachelor's Degree in life sciences or related field (Req)
- Master's Degree (Pref)
- Ph.D. in life sciences or related field (Pref)
- At least 8 years of relevant experience (Req)
- Deep knowledge of clinical study reports, protocols, and document deficiencies.
- Understanding of statistical methods and interpretation in clinical trials.
- Ability to review statistical analysis plans and outputs for accuracy.
- Experience in preparing CSRs, protocols, CTDs, and handling complex documents.
- Knowledge of drug development, medical writing regulations, and medical terminology.
- Excellent communication, attention to detail, negotiation, and interpersonal skills.
- Ability to manage multiple projects, demonstrate leadership, influence others, and build relationships.
- Proficiency with computer tools.
IQVIA is a global leader in clinical research and healthcare intelligence, committed to innovation and impact. We value diversity and are an equal opportunity employer. Thank you for your interest in growing your career with us.
Principal Medical Writer employer: Nanosep AB
Contact Detail:
Nanosep AB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer
✨Tip Number 1
Familiarise yourself with the latest trends in medical writing and drug development. This 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. Attend relevant conferences or webinars, and connect with current employees at StudySmarter on platforms like LinkedIn to gain insights into the company culture and expectations.
✨Tip Number 3
Prepare to discuss specific projects you've managed that align with the responsibilities of a Principal Medical Writer. Highlight your leadership skills and how you've successfully navigated complex document types and customer requirements.
✨Tip Number 4
Brush up on your negotiation and communication skills. Be ready to showcase examples where you've effectively resolved conflicts or led meetings, as these are crucial for the role and will set you apart from other candidates.
We think you need these skills to ace Principal Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in medical writing, particularly your ability to manage large projects and your knowledge of clinical study reports and protocols. Use specific examples that demonstrate your leadership and negotiation skills.
Craft a Compelling Cover Letter: In your cover letter, express your passion for medical writing and how your background aligns with the role. Mention your experience in managing customer accounts and your ability to communicate complex topics to diverse audiences.
Showcase Your Knowledge: Demonstrate your understanding of current medical writing regulations and drug development processes. You could include any relevant certifications or training you've completed that would enhance your application.
Proofread and Edit: Before submitting your application, thoroughly proofread all documents. Ensure there are no grammatical errors or typos, as attention to detail is crucial in medical writing. Consider asking a colleague to review your application for additional feedback.
How to prepare for a job interview at Nanosep AB
✨Showcase Your Leadership Skills
As a Principal Medical Writer, you'll be expected to lead projects and manage teams. Be prepared to discuss your previous leadership experiences, how you resolved conflicts, and your approach to chairing meetings. Highlight specific examples where your negotiation skills made a difference.
✨Demonstrate Your Technical Knowledge
Make sure to brush up on your understanding of clinical study reports, protocols, and the latest medical writing regulations. Be ready to discuss your experience with complex documents and statistical methods, as this will show your depth of knowledge in the field.
✨Prepare for Customer Interaction Scenarios
Since managing customer accounts is a key part of the role, think about how you would handle various customer requests and feedback. Prepare examples of how you've successfully communicated complex medical writing topics to diverse audiences in the past.
✨Highlight Your Project Management Experience
With a focus on managing large Medical Writing projects, it's crucial to demonstrate your ability to plan, organise, and track timelines effectively. Discuss any tools or methodologies you've used to ensure project efficiency and consistency, and be ready to talk about how you monitor budgets and resources.
