Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead the creation of clinical documents for global regulatory submissions in oncology.
- Company: Join a leading global pharmaceutical company focused on innovative oncology solutions.
- Benefits: Enjoy remote work flexibility and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with talented professionals.
- Qualifications: Requires 7+ years in medical writing and a relevant degree; advanced degree preferred.
- Other info: Mentorship opportunities available for junior writers.
The predicted salary is between 48000 - 72000 £ per year.
Remote Associate Director, Principal Medical Writer working through an FSP model for a Global Oncology focused Pharmaceutical Company
The Associate Director, Principal Medical Writer is responsible for developing clinical documents for regulatory submissions worldwide. This role involves leading cross-functional project teams to ensure documents—such as Investigators\’ Brochures (IBs) and Clinical Study Reports (CSRs)—accurately present clinical data in line with regulatory requirements.
Key Responsibilities:
- Write or supervise the writing of high-quality, scientifically rigorous documents. –
- Oversee medical writing for multiple compounds and lead regulatory submissions. – Participate in cross-functional meetings to discuss medical writing deliverables and timelines.
- -Review relevant project documents, such as Protocols and Statistical Analysis Plans. –
- Mentor junior writers and contribute to process improvement initiatives.
Qualifications:
- A bachelor’s degree is required; an advanced degree is preferred.
- Minimum 7 years of medical writing experience in the biopharmaceutical or CRO industry.
- Strong ability to understand and interpret clinical data, with excellent project management skills. – Strong verbal, written, and interpersonal communication skills. –
- Knowledge of global regulatory requirements and therapeutic areas in clinical development.
- Proficiency in MS Word and experience with electronic document management systems is essential.
- This position requires effective interaction with team members and senior leaders to facilitate communication and problem-solving.
Associate Director, Principal Medical Writer employer: Advanced Clinical
Contact Detail:
Advanced Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Principal Medical Writer
✨Tip Number 1
Network with professionals in the biopharmaceutical and CRO industries. Attend relevant conferences or webinars to connect with others in medical writing and oncology, as personal connections can often lead to job opportunities.
✨Tip Number 2
Familiarise yourself with the latest global regulatory requirements and guidelines in clinical development. This knowledge will not only enhance your expertise but also demonstrate your commitment to staying updated in the field during interviews.
✨Tip Number 3
Prepare to discuss specific examples of your project management experience and how you've led cross-functional teams in the past. Highlighting these skills will show that you can effectively manage the responsibilities of the Associate Director role.
✨Tip Number 4
Consider reaching out to current or former employees of StudySmarter or the hiring company on platforms like LinkedIn. Engaging in conversations about their experiences can provide valuable insights and potentially give you an edge in the application process.
We think you need these skills to ace Associate Director, Principal Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your medical writing experience, especially in the biopharmaceutical or CRO industry. Emphasise your project management skills and any relevant qualifications that align with the job description.
Craft a Compelling Cover Letter: In your cover letter, explain why you are a great fit for the Associate Director, Principal Medical Writer role. Mention specific experiences that demonstrate your ability to lead cross-functional teams and your understanding of regulatory requirements.
Showcase Your Writing Skills: Include samples of your previous work, such as clinical documents or reports, to showcase your writing style and ability to present complex data clearly. Ensure these samples reflect high-quality, scientifically rigorous writing.
Highlight Leadership Experience: Since the role involves mentoring junior writers and leading projects, be sure to highlight any leadership roles you've held. Discuss how you've contributed to process improvements and supported team members in their development.
How to prepare for a job interview at Advanced Clinical
✨Showcase Your Writing Skills
As a Principal Medical Writer, your writing skills are paramount. Be prepared to discuss specific examples of documents you've written or supervised, such as Investigators' Brochures or Clinical Study Reports. Highlight how your writing has met regulatory standards and contributed to successful submissions.
✨Demonstrate Project Management Expertise
This role requires strong project management skills. Be ready to share experiences where you led cross-functional teams or managed multiple projects simultaneously. Discuss how you ensured timelines were met and how you handled any challenges that arose during the process.
✨Understand Regulatory Requirements
Familiarise yourself with global regulatory requirements relevant to oncology and clinical development. During the interview, be prepared to discuss how you have navigated these regulations in your previous roles and how you ensure compliance in your writing.
✨Emphasise Mentorship and Team Collaboration
Mentoring junior writers is a key responsibility in this position. Share examples of how you've supported and guided less experienced colleagues in the past. Additionally, highlight your ability to collaborate effectively with team members and senior leaders to foster a productive working environment.
