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For Companies At a Glance
- Tasks: Lead the medical writing team on clinical study documents and ensure regulatory compliance.
- Company: Join a global CRO dedicated to innovative solutions for persistent diseases.
- Benefits: Enjoy remote work, ongoing training, and a supportive, inclusive culture.
- Why this job: Make a real impact on patients' lives while thriving in a creative environment.
- Qualifications: 4+ years as a Medical Writer; life science degree or equivalent experience required.
- Other info: Opportunities for travel and collaboration with diverse teams across the globe.
The predicted salary is between 36000 - 60000 £ per year.
Who we are
We\’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world\’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What Medical Writing does at Worldwide Clinical Trials
Medical Writing at Worldwide is a dynamic global group with comprehensive peer, leadership and administrative support. Our team liaises with Subject Matter Experts across the company, including regulatory strategists and clinical methodologists in high level protocol and clinical development discussions. We also author a wide range of documents across many therapeutic areas. Join us and discover opportunities for ongoing training and career development.
What you will do
- Prepare and lead the medical writing team on Phase I-IV study documents such as protocols and protocol amendments, informed consent documents and assents, complete clinical trial reports (CTRs), CTR narratives, Investigator Brochures, and other study-related documents in accordance with regulatory requirements (USA, Europe and/or ROW) and SOPs.
- Prepare and lead the medical writing team on Phase I-IV study documents that are applicable in regions outside of the USA, including but not limited to IMPDs, Protocol Lay Summaries, CTR Lay Summaries, Assents etc.
- Work with other departments in Worldwide preparing and leading the development of Pre-IND documents, synopsis, briefing books for all authorities (FDA, EMA, MHRA, Health Canada etc.) and updating all documents following agency feedback.
- Responsible for key documents template management in accordance with global regulations.
- Serve as publishing point-of-contact in conjunction with the Publisher for CTRs or other documents, as needed.
What you will bring to the role
- Excellent written and spoken English.
- Ability to accurately interpret data and express findings in a clear and concise written manner.
- Excellent project/time management and organizational skills, and ability to work independently.
- Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
- Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook.
- Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).
Your Experience
- University/college degree (life science or related allied health profession) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities.
- Minimum of 4 years of experience as a Medical Writer or equivalent role as determined by management to have sufficient skills and knowledge.
- Available for domestic and international travel, including overnight stays (valid passport).
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We\’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law #J-18808-Ljbffr
Senior Medical Writer - Europe - Remote employer: Worldwide Clinical Trials
Contact Detail:
Worldwide Clinical Trials Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer - Europe - Remote
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements and guidelines mentioned in the job description, such as ICH E3, E6, and E9. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during any discussions.
✨Tip Number 2
Network with current or former medical writers at Worldwide Clinical Trials on platforms like LinkedIn. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during interviews.
✨Tip Number 3
Prepare to discuss your experience with various types of clinical documents, especially those relevant to Phase I-IV studies. Be ready to share specific examples of how you've successfully managed multiple projects under tight deadlines.
✨Tip Number 4
Showcase your flexibility and adaptability by preparing examples of how you've navigated changing requirements in past roles. This will highlight your ability to thrive in a dynamic environment, which is crucial for this position.
We think you need these skills to ace Senior Medical Writer - Europe - Remote
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical writing, particularly in preparing clinical trial documents. Emphasise your familiarity with regulatory requirements and any specific therapeutic areas you have worked in.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for improving lives through medical writing. Mention your understanding of the role's responsibilities and how your skills align with Worldwide Clinical Trials' mission and values.
Showcase Your Skills: In your application, clearly demonstrate your excellent written and spoken English skills. Provide examples of how you've effectively communicated complex data in previous roles, as this is crucial for the position.
Highlight Project Management Experience: Since the role requires excellent project and time management skills, include specific examples of how you've successfully managed multiple projects and met challenging deadlines in your past work.
How to prepare for a job interview at Worldwide Clinical Trials
✨Showcase Your Writing Skills
As a Senior Medical Writer, your ability to communicate complex information clearly is crucial. Bring samples of your previous work to the interview and be prepared to discuss your writing process and how you ensure compliance with regulatory requirements.
✨Demonstrate Your Knowledge of Regulations
Familiarise yourself with key regulatory guidelines such as ICH E3, E6, and E9. Be ready to discuss how you have applied these in your past roles, as this will show your understanding of the industry standards expected by Worldwide Clinical Trials.
✨Highlight Your Project Management Skills
Given the need for excellent project and time management skills, prepare examples of how you've successfully managed multiple projects under tight deadlines. Discuss any tools or methods you use to stay organised and efficient.
✨Emphasise Team Collaboration
Worldwide Clinical Trials values collaboration across departments. Be prepared to share experiences where you worked with cross-functional teams, highlighting your ability to liaise with Subject Matter Experts and adapt to feedback from various stakeholders.
