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- Tasks: Lead and mentor medical writing projects, creating essential clinical documents.
- Company: Syneos Health is a global biopharmaceutical solutions leader focused on customer success.
- Benefits: Enjoy a supportive culture, career development, and the flexibility of home-based work.
- Why this job: Make a real impact in healthcare while collaborating with passionate problem solvers.
- Qualifications: Bachelor's degree in relevant fields with strong writing and scientific knowledge required.
- Other info: Minimal travel required; join a diverse team dedicated to innovation and inclusion.
The predicted salary is between 42000 - 84000 £ per year.
Senior Medical Writer – Regulatory – United Kingdom and Ireland (homebased)
Join to apply for the Senior Medical Writer – Regulatory – United Kingdom and Ireland (homebased) role at Syneos Health
Senior Medical Writer – Regulatory – United Kingdom and Ireland (homebased)
1 day ago Be among the first 25 applicants
Join to apply for the Senior Medical Writer – Regulatory – United Kingdom and Ireland (homebased) role at Syneos Health
Description
Senior Medical Writer – Regulatory – United Kingdom and Ireland (homebased)
Description
Senior Medical Writer – Regulatory – United Kingdom and Ireland (homebased)
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.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. 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
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
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, as well as;
- Clinical journal manuscripts, clinical journal abstracts, and client presentations.
- 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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Marketing, Public Relations, and Writing/Editing
-
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
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Senior Medical Writer - Regulatory - United Kingdom and Ireland (homebased) employer: Syneos Health
Contact Detail:
Syneos Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer - Regulatory - United Kingdom and Ireland (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 regulatory standards during interviews.
✨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 your application process.
✨Tip Number 3
Prepare to discuss specific examples of your previous medical writing projects, especially those that involved complex documents like clinical study reports or IND submissions. This will showcase your experience and ability to handle the responsibilities of the role.
✨Tip Number 4
Stay updated on current trends in clinical research and medical writing. Being able to discuss recent developments in the field during your interview can set you apart from other candidates and show your passion for the industry.
We think you need these skills to ace Senior Medical Writer - Regulatory - United Kingdom and Ireland (homebased)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical writing and regulatory affairs. 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 skills can contribute to Syneos Health's mission. Mention specific examples of your previous work that demonstrate your ability to manage complex writing projects.
Showcase Leadership Skills: Since the role involves mentoring less experienced writers, include examples of your leadership experience. Highlight instances where you have guided teams or contributed to the development of others in your field.
Proofread Thoroughly: Given the emphasis on grammar and adherence to regulatory standards, ensure that your application materials are free from errors. Consider having a colleague review your documents to catch any mistakes you might have missed.
How to prepare for a job interview at Syneos Health
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing skills are paramount. Bring samples of your previous work that demonstrate your ability to create clear and concise medical documents. Be prepared to discuss your writing process and how you ensure compliance with regulatory standards.
✨Understand Regulatory Guidelines
Familiarise yourself with FDA and ICH regulations, as well as the AMA style guide. During the interview, be ready to discuss how you have applied these guidelines in your past projects and how you stay updated on any changes in the industry.
✨Demonstrate Leadership Experience
Since the role involves mentoring less experienced writers, highlight any leadership or mentoring experiences you have. Share specific examples of how you've guided teams or individuals through complex writing projects.
✨Prepare for Technical Questions
Expect technical questions related to clinical research principles and data interpretation. Brush up on your knowledge of clinical study protocols, reports, and submissions. Being able to articulate your understanding will show your expertise and confidence in the field.
