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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 talented professionals.
- Qualifications: Requires 7+ years in medical writing; 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
Familiarise yourself with the latest global regulatory requirements in oncology. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those involved in medical writing. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your project management experience. Highlight instances where you've led cross-functional teams or mentored junior writers, as these are key aspects of the role.
✨Tip Number 4
Showcase your proficiency in MS Word and any electronic document management systems you've used. Being able to discuss your technical skills confidently can set you apart from other candidates.
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, express your passion for oncology and regulatory submissions. Mention specific examples of documents you have developed, such as Investigators' Brochures or Clinical Study Reports, to demonstrate your expertise.
Highlight Leadership Experience: Since the role involves mentoring junior writers and leading cross-functional teams, be sure to include any leadership roles you've held. Discuss how you've contributed to process improvements in previous positions.
Showcase Communication Skills: Given the importance of communication in this role, provide examples of how you've effectively interacted with team members and senior leaders. This could include successful collaborations or presentations you've led.
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. Be ready to explain how you managed timelines, coordinated with cross-functional teams, and ensured successful regulatory submissions.
✨Understand Regulatory Requirements
Familiarise yourself with global regulatory requirements relevant to oncology. Be prepared to discuss how you have navigated these in past roles and how you stay updated on changes in regulations.
✨Prepare for Team Dynamics Questions
Since this role involves mentoring junior writers and collaborating with senior leaders, expect questions about team dynamics. Think of examples where you've successfully mentored others or resolved conflicts within a team.
