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- 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 diverse teams and mentoring others.
- Qualifications: Requires a bachelor’s degree, 7 years of medical writing experience, and strong communication skills.
- Other info: This role offers a chance to shape the future of cancer treatment.
The predicted salary is between 43200 - 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
Familiarise yourself with the specific regulatory requirements for clinical documents in oncology. Understanding these nuances will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those who have experience in medical writing. Engaging in conversations can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your project management experiences in detail. Highlight specific examples where you led cross-functional teams or improved processes, as this is crucial for the Associate Director position.
✨Tip Number 4
Showcase your mentoring skills by preparing examples of how you've supported junior writers in the past. This will illustrate your leadership capabilities and align with the responsibilities of the role.
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 regulatory submissions, if possible. This will give the hiring team a clear idea of your writing style and expertise in producing high-quality scientific documents.
Highlight Leadership Experience: Since the role involves mentoring junior writers and leading projects, be sure to include examples of your leadership experience. 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 ability is crucial. Bring samples of your previous work to the interview, and be prepared to discuss your writing process and how you ensure accuracy and compliance with regulatory standards.
✨Demonstrate Project Management Experience
Highlight your project management skills by discussing specific projects you've led. Explain how you coordinated with cross-functional teams and managed timelines, as this role requires strong organisational abilities.
✨Familiarise Yourself with Regulatory Requirements
Brush up on global regulatory requirements relevant to clinical documents. Be ready to discuss how you have navigated these in past roles, as understanding these regulations is key for the position.
✨Prepare for Team Interaction Scenarios
Since effective communication with team members and senior leaders is essential, prepare examples of how you've successfully collaborated in the past. Think about challenges you faced and how you resolved them through teamwork.
