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- Tasks: Manage Module 3 writing projects for US and EU regulatory submissions.
- Company: Proclinical connects top talent with leading life sciences opportunities worldwide.
- Benefits: Enjoy remote work flexibility and the chance to make a global impact.
- Why this job: Shape powerful strategies in oncology and biotechnology while collaborating with experts.
- Qualifications: Experience in CMC medical writing and proven leadership in NDA and MAA submissions required.
- Other info: Contact Peter Duvall for any application queries or assistance.
The predicted salary is between 36000 - 60000 £ per year.
Work from anywhere and shape powerful strategies that drive results! Enjoy the freedom of remote work while making a global impact.
Proclinical is seeking a skilled CMC Writer to join our client's team, focusing on regulatory affairs within the oncology and biotechnology sectors. This role involves managing Module 3 writing projects and updates for both US and EU submissions. You will work remotely, collaborating with subject matter experts and contract manufacturing organizations to ensure timely and high-quality document completion.
Responsibilities:
- Manage a range of Module 3 deliverables, including new sections and updates for simultaneous US and EU filings.
- Lead the writing process for NDA and MAA submissions, as well as follow-on variations and supplements.
- Coordinate with global experts and gather necessary data from CMOs.
- Ensure documents are polished and ready for agency submission.
Key Skills and Requirements:
- Extensive experience in CMC medical writing for small or large molecules.
- Proven leadership in NDA and MAA submissions.
- Ability to work independently and manage multiple projects simultaneously.
- Strong communication skills to effectively collaborate with diverse teams.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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CMC Writer employer: Proclinical Staffing
Contact Detail:
Proclinical Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Writer
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for Module 3 submissions in both the US and EU. 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 oncology and biotechnology sectors. Engaging with industry experts can provide insights into current trends and challenges, making you a more attractive candidate.
✨Tip Number 3
Showcase your leadership skills by discussing past experiences where you successfully managed multiple writing projects. Highlighting your ability to coordinate with diverse teams will set you apart from other candidates.
✨Tip Number 4
Prepare for potential interviews by practising how to articulate your experience with NDA and MAA submissions. Being able to clearly explain your process and results will impress hiring managers.
We think you need these skills to ace CMC Writer
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a CMC Writer. Familiarise yourself with Module 3 deliverables and the specifics of NDA and MAA submissions to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your extensive experience in CMC medical writing, particularly for small or large molecules. Mention any leadership roles you've held in NDA and MAA submissions to showcase your qualifications.
Showcase Communication Skills: Since the role requires collaboration with diverse teams, highlight your strong communication skills. Provide examples of how you've effectively worked with subject matter experts and contract manufacturing organisations in past projects.
Tailor Your Application: Customise your application documents to reflect the specific requirements mentioned in the job description. Use keywords from the listing to demonstrate that you are a perfect fit for the position.
How to prepare for a job interview at Proclinical Staffing
✨Showcase Your CMC Expertise
Make sure to highlight your extensive experience in CMC medical writing during the interview. Be prepared to discuss specific projects you've worked on, especially those involving NDA and MAA submissions, as this will demonstrate your capability to handle the responsibilities of the role.
✨Demonstrate Leadership Skills
Since the role requires proven leadership in managing Module 3 deliverables, share examples of how you've led writing projects in the past. Discuss how you coordinated with teams and ensured timely completion of documents, which will show your ability to manage multiple projects effectively.
✨Prepare for Collaboration Questions
Expect questions about your communication skills and how you collaborate with diverse teams. Think of instances where you successfully worked with subject matter experts or contract manufacturing organisations, as this will illustrate your ability to work independently while still being a team player.
✨Research the Company and Sector
Familiarise yourself with Proclinical and its focus on regulatory affairs within oncology and biotechnology. Understanding the company's mission and the specifics of the industry will allow you to tailor your responses and show genuine interest in the position.
