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- Tasks: Join us as a Senior Medical Writer, crafting essential documents for clinical studies.
- Company: Syneos Health is a global leader in biopharmaceutical solutions, dedicated to accelerating customer success.
- Benefits: Enjoy career development, a supportive culture, and the chance to work with diverse teams.
- Why this job: Make a real impact on patients' lives while working in an innovative and inclusive environment.
- Qualifications: A degree in science or arts with relevant writing experience and strong English skills required.
- Other info: Minimal travel required; we value diverse backgrounds and encourage all to apply.
The predicted salary is between 36000 - 60000 £ 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 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.
Job Responsibilities:
- Mentors less experienced medical writers on projects, as necessary.
- Compiles, writes, and edits medical writing deliverables, and serves as a medical writer 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 study protocol amendments;
- Clinical study reports;
- Patient narratives;
- Annual reports;
- Investigator brochures.
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.
Senior Medical Writer - Regulatory employer: Syneos Health, Inc.
Contact Detail:
Syneos Health, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer - Regulatory
✨Tip Number 1
Familiarise yourself with the ICH-E3 guidelines and FDA regulations, as these are crucial for a Senior Medical Writer role. Understanding these standards will not only help you in your application but also demonstrate your commitment to regulatory compliance.
✨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 your experience with mentoring less experienced writers. Highlight specific examples where you've guided others, as this aligns with the responsibilities of the role and shows your leadership capabilities.
✨Tip Number 4
Stay updated on the latest trends in medical writing and drug development. Being knowledgeable about recent advancements can set you apart and show your passion for the field during discussions with the hiring team.
We think you need these skills to ace Senior Medical Writer - Regulatory
Some tips for your application 🫡
Understand the Role: Before you start writing your application, make sure you fully understand the responsibilities and qualifications required for the Senior Medical Writer position. Tailor your application to highlight how your skills and experiences align with these requirements.
Craft a Compelling CV: Your CV should clearly outline your relevant experience in medical writing, particularly in regulatory contexts. Emphasise your familiarity with ICH guidelines and any specific documents you've worked on, such as clinical study protocols or reports.
Write a Strong Cover Letter: In your cover letter, express your passion for the role and the biopharmaceutical industry. Mention specific examples of your previous work that demonstrate your ability to mentor others and produce high-quality medical writing deliverables.
Proofread Your Application: Ensure that your application is free from grammatical errors and typos. Given the importance of precision in medical writing, a polished application will reflect your attention to detail and professionalism.
How to prepare for a job interview at Syneos Health, Inc.
✨Know Your Documents
Familiarise yourself with the types of documents you'll be working on, such as clinical study protocols and reports. Being able to discuss these confidently will show your understanding of the role and its requirements.
✨Brush Up on Regulatory Guidelines
Make sure you have a solid grasp of FDA and ICH regulations, as well as the AMA style guide. This knowledge is crucial for a Senior Medical Writer, and demonstrating it in your interview will set you apart.
✨Showcase Your Mentoring Skills
Since the role involves mentoring less experienced writers, be prepared to discuss any past experiences where you've guided others. Highlighting your leadership skills can demonstrate your fit for the team-oriented culture.
✨Prepare for Technical Questions
Expect questions that assess your technical writing skills and your ability to interpret complex clinical data. Practising how to articulate your thought process will help you respond effectively during the interview.
