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- Tasks: Lead and mentor medical writing projects, ensuring high-quality deliverables.
- Company: Join Syneos Health, a top biopharmaceutical solutions organisation dedicated to accelerating customer success.
- Benefits: Enjoy remote work options, career development, and a supportive culture that values diversity.
- Why this job: Make a real impact in healthcare while collaborating with passionate problem solvers in a dynamic environment.
- Qualifications: Bachelor's degree in relevant fields with strong writing skills and knowledge of clinical research.
- Other info: Flexible roles available; we value diverse experiences and encourage all to apply.
The predicted salary is between 43200 - 72000 £ per year.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE.
Job Responsibilities
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Acts as lead for assigned writing projects.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Develops or supports a variety of documents that include, but not limited to:
- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures;
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
Qualifications
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased employer: Syneos Health, Inc.
Contact Detail:
Syneos Health, Inc. Recruiting Team
jobs@syneoshealth.com
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased
✨Tip Number 1
Familiarise yourself with the latest ICH and FDA regulations, as well as AMA style guidelines. This knowledge will not only help you in your writing but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with current or former employees of Syneos Health 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 specific examples of your previous medical writing projects. Highlight your ability to manage complex documents and mentor less experienced writers, as these are key responsibilities for the role.
✨Tip Number 4
Showcase your leadership skills by discussing how you've successfully led projects or teams in the past. This will align with the job's requirement for mentoring and leading less experienced writers.
We think you need these skills to ace Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical writing, particularly in regulatory contexts. Emphasise your familiarity with ICH guidelines and any specific projects that align with the responsibilities listed in the job description.
Craft a Compelling Cover Letter: In your cover letter, express your passion for medical writing and how your background aligns with Syneos Health's mission. Mention specific skills such as leadership in writing projects and your ability to mentor others, as these are key aspects of the role.
Showcase Your Writing Skills: Include samples of your previous work that demonstrate your proficiency in creating clinical documents. If possible, provide examples that reflect your understanding of regulatory requirements and your ability to present complex information clearly.
Highlight Continuous Learning: Mention any recent training or courses you've completed related to medical writing or regulatory affairs. This shows your commitment to staying updated with industry practices and enhances your application by demonstrating your proactive approach to professional development.
How to prepare for a job interview at Syneos Health, Inc.
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing skills are paramount. Bring samples of your previous work to the interview, especially documents that align with regulatory submissions or clinical study reports. This will demonstrate your expertise and familiarity with the required standards.
✨Understand Regulatory Guidelines
Familiarise yourself with FDA and ICH regulations, as well as the AMA style guide. Be prepared to discuss how you have applied these guidelines in your past projects. This knowledge will show that you can navigate the complexities of medical writing effectively.
✨Demonstrate Leadership Experience
Since the role involves mentoring less experienced writers, be ready to share examples of how you've led teams or projects in the past. Highlight your ability to provide constructive feedback and support others in their development.
✨Prepare for Technical Questions
Expect questions related to clinical research principles and data interpretation. Brush up on your understanding of clinical trial processes and be ready to discuss how you would approach writing various types of documents, such as clinical protocols or study reports.
