At a Glance
- Tasks: Craft and manage regulatory documents for groundbreaking biopharmaceutical applications.
- Company: Join a global biopharmaceutical leader focused on healthcare innovation and sustainability.
- Benefits: Competitive pay, remote work, and a chance to impact lives positively.
- Other info: 12-month contract with opportunities for growth in a dynamic environment.
- Why this job: Be part of a team that shapes the future of healthcare through innovative documentation.
- Qualifications: Degree in life sciences and experience in scientific writing required.
Your new company is a global biopharmaceutical company focused on healthcare innovation and environmental sustainability, specialising in Oncology, neurology, and rare diseases. They have a position available for a Regulatory Medical Writer to join their Non-clinical Submission & Documentation Management team on an initial 12-month contract.
Contract Details:
- Remote
- 12 Month + Contract
- Outside IR35
- £75 p/h - £90 p/h
Your new role:
As the Regulatory Documentation Scientist (non-clinical scientific writer), you will manage the submission of authored non-clinical documents to regulatory agencies in support of applications such as INDs, CTAs, NDAs, MAAs, and BLAs. You will ensure that the documents are clearly written, accurate, consistent, adhere to the company's and ICH standards, and are reviewed and approved by the appropriate functional groups.
- Manage the preparation, review, and submission of non-clinical summary documents for both early development and marketing applications.
- Work with regulatory and scientific functions to ensure comprehensive and accurate non-clinical dossiers are submitted to HAs.
- Collaborate closely with non-clinical project leaders and scientists in composing regulatory submission documents, study reports, and other research-related documents.
- Develop and maintain processes, tools, and guidelines enabling high-quality document production.
- Represent the non-clinical team in global regulatory initiatives and projects focused on process and technology development.
What you’ll need to succeed:
- You hold a university degree in a life science.
- You have several years of working experience in scientific writing and editing in a non-clinical, regulatory domain.
- You have an excellent command of writing and editing software, with an interest in exploring and integrating new tools and technologies.
- You build a culture of trust around you and are comfortable working with a wide array of stakeholders.
- You are obsessed with meeting customer needs and thus, high-quality documentation.
- You take ownership of your work and are proactive in taking action to resolve issues.
- Unwavering focus, collaborative teamwork, and exceptional delivery.
What you need to do now:
Before you apply for this position, it is vital that you possess a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
If you’re interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins.
Regulatory Medical Writer - IND, CTA, NDA, MAA, BLA in Welwyn Garden City employer: Hays Life Sciences
Join a leading global biopharmaceutical company that prioritises healthcare innovation and environmental sustainability, offering a dynamic work culture where your contributions directly impact the quality of life for patients. With a strong focus on employee growth, you will have access to continuous learning opportunities and the chance to collaborate with experts in oncology, neurology, and rare diseases, all while enjoying the flexibility of remote work. This role not only provides competitive pay but also places you at the forefront of regulatory advancements in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Medical Writer - IND, CTA, NDA, MAA, BLA in Welwyn Garden City
✨Tip Number 1
Network like a pro! Reach out to professionals in the biopharmaceutical field, especially those who work in regulatory writing. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of INDs, CTAs, NDAs, MAAs, and BLAs. Be ready to discuss how your experience aligns with the role and showcase your scientific writing skills. Practice common interview questions to boost your confidence!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values, like those committed to healthcare innovation and sustainability. Tailor your approach when applying through our website to show you’re genuinely interested in their mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in leaving a positive impression. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Regulatory Medical Writer - IND, CTA, NDA, MAA, BLA in Welwyn Garden City
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in regulatory writing, especially with INDs, CTAs, NDAs, MAAs, and BLAs. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory writing and how your background in life sciences makes you a perfect fit for our team. Keep it concise but impactful!
Showcase Your Technical Skills:Since we’re looking for someone with a solid command of writing and editing software, make sure to mention any tools or technologies you’ve used in your previous roles. We love seeing candidates who are eager to explore new tech!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on the specifics of INDs, CTAs, NDAs, MAAs, and BLAs. Familiarise yourself with the latest ICH standards and be ready to discuss how your experience aligns with these requirements.
✨Showcase Your Writing Skills
Prepare samples of your previous regulatory documents or writing projects. Be ready to explain your writing process and how you ensure clarity and accuracy in your work. This is your chance to shine!
✨Demonstrate Team Spirit
Since collaboration is key in this role, think of examples where you've worked closely with scientists or regulatory teams. Highlight how you build trust and foster teamwork to achieve high-quality outcomes.
✨Be Proactive and Solution-Oriented
Come prepared with examples of how you've taken ownership of your work and resolved issues in the past. Show that you're not just a writer but a problem-solver who can navigate challenges effectively.
