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- Tasks: Coordinate and manage medical writing tasks for clinical trials and regulatory submissions.
- Company: Join Aixial Group, a leading CRO dedicated to improving clinical trials and saving lives.
- Benefits: Flexible home-based or hybrid work options, professional growth opportunities, and a supportive environment.
- Why this job: Make a real impact in healthcare by delivering high-quality documents that support patient care.
- Qualifications: Advanced degree in life sciences and 5-10 years of medical writing experience required.
- Other info: Collaborative culture with opportunities to work on multiple projects and develop your skills.
The predicted salary is between 36000 - 60000 £ per year.
The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I – IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials.
We are currently looking for an enthusiastic and talented Senior Medical Writer for a client dedicated opportunity. This role is home-based in the UK or EU, or office-based/hybrid in Denmark and Sweden. The successful candidate will be overall responsibility for coordinating and managing medical writing tasks, including timely delivery of high-quality documents in accordance with agreements made between Aixial and sponsor. Key medical writing tasks include clinical study reports, Investigator's Brochure (IB) updates, protocols, as well as summary documents and clinical overviews for submission to regulatory authorities. The candidate will be expected to work in alignment with company values and in compliance with ICH-GCP, national and international regulations and the client's quality system. They must provide timely feedback to management on work progress and actively participate in scheduled training sessions and required reading. Other medical writing tasks may be assigned as needed.
Aixial offers a friendly and stimulating work environment, with ample opportunities for professional growth.
Qualifications- Advanced degree in life science
- Preferably 5 – 10 years of relevant medical writing experience
- Ability to structure and plan own work according to agreed timelines
- Excellent attention to detail combined with an understanding of the document's overall purpose
- Ability to work simultaneously on more than one project
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Knowledge of GCP as well as relevant ICH guidelines
- Good knowledge of Microsoft Office 365. Experience with Veeva and PleaseReview is a plus.
- The job holder will need to be fluent in spoken and written English.
Senior Medical Writer in Newcastle upon Tyne employer: Aixial Group
Contact Detail:
Aixial Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer in Newcastle upon Tyne
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical writing field on LinkedIn or at industry events. We can help you connect with others who might know about job openings or can give you insider tips.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios specific to medical writing. We suggest doing mock interviews with friends or using online resources to boost your confidence and refine your answers.
✨Tip Number 3
Showcase your expertise! Create a portfolio of your best writing samples that highlight your skills in clinical study reports and protocols. We believe this will set you apart from other candidates and demonstrate your capabilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we often have exclusive opportunities listed there that you won’t find anywhere else.
We think you need these skills to ace Senior Medical Writer in Newcastle upon Tyne
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Medical Writer role. Highlight your relevant experience, especially in medical writing and clinical trials. We want to see how your skills align with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your background makes you a perfect fit. Don’t forget to mention your understanding of ICH-GCP and any specific experiences that relate to our work.
Showcase Your Attention to Detail: As a medical writer, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their work meticulously, just like we do in our documents!
Apply Through Our Website: We encourage you to apply directly through our careers page. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at Aixial!
How to prepare for a job interview at Aixial Group
✨Know Your Stuff
Make sure you brush up on your medical writing knowledge, especially around clinical study reports and protocols. Familiarise yourself with ICH-GCP guidelines and any relevant regulations, as this will show that you're serious about the role and understand the industry's standards.
✨Showcase Your Experience
Prepare to discuss your previous medical writing projects in detail. Highlight your ability to manage multiple tasks and meet deadlines, as well as any specific tools you've used like Microsoft Office 365 or Veeva. This will help demonstrate your fit for the role and your capability to deliver high-quality documents.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the company and the role. Ask about their approach to clinical trials or how they support professional growth within the team. This not only shows your enthusiasm but also helps you gauge if the company culture aligns with your values.
✨Be Yourself
While it's important to be professional, don't forget to let your personality shine through. Aixial values a friendly work environment, so showing your enthusiasm and passion for medical writing can make a positive impression. Remember, they want to see how you'd fit into their team!