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- Tasks: Lead medical writing projects and create essential clinical documents.
- Company: Join Syneos Health, a top biopharmaceutical solutions organisation dedicated to accelerating customer success.
- Benefits: Enjoy a fully remote role with career development opportunities and a supportive culture.
- Why this job: Make a real impact in healthcare while working with passionate problem solvers in a diverse environment.
- Qualifications: Bachelor's degree in relevant fields and experience as a Senior Medical Writer required.
- Other info: Work with a company that has contributed to 94% of all Novel FDA Approved Drugs.
The predicted salary is between 42000 - 84000 £ per year.
Single Sponsor Senior Clinical Medical Writer – (fully home based) 6 month FTC
6 days ago Be among the first 25 applicants
Description
Single Sponsor Senior Clinical Medical Writer – (fully home based) 6 month FTC
Description
Single Sponsor Senior Clinical Medical Writer – (fully home based) 6 month FTC
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
- 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.
- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
- Serves as peer reviewer on internal review team providing review comments on draft and final documents.
- Adheres to established regulatory standards,including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
- Performs on-line clinical literature searches, as applicable.
- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
- Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
- Completes required administrated tasks within the specified timeframes.
- Performs other work-related duties as assigned.
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.
- Previous experience as a Senior Medical Writer working in a CRO or Pharma. 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.
- Needs experience writing clinical and submission ready documents.
- Oncology / Auto-immune diseases exp.
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
Business Development and Sales
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Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
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Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC employer: Syneos Health
Contact Detail:
Syneos Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC
✨Tip Number 1
Familiarise yourself with the specific regulatory guidelines mentioned in the job description, such as ICH-E3 and FDA regulations. This knowledge will not only help you during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with current or former employees of Syneos Health on platforms like LinkedIn. Engaging with them can provide valuable insights into the company culture and expectations, which can be beneficial during your interview.
✨Tip Number 3
Prepare to discuss your experience with clinical documents in detail. Be ready to share specific examples of projects you've worked on, particularly those related to oncology or auto-immune diseases, as this aligns closely with the job requirements.
✨Tip Number 4
Showcase your ability to work independently and lead projects by preparing anecdotes that highlight your leadership skills. This will resonate well with the company's emphasis on a team-oriented approach and independence.
We think you need these skills to ace Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical writing, particularly in clinical study protocols and regulatory submissions. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical writing and your understanding of the biopharmaceutical industry. Mention specific projects or experiences that align with the responsibilities listed in the job description.
Showcase Your Writing Skills: Include samples of your previous work that demonstrate your ability to write clinical documents. Ensure these samples are well-structured and free of errors, as this reflects your attention to detail and proficiency in English grammar.
Highlight Relevant Qualifications: In your application, emphasise your educational background and any certifications related to medical writing or clinical research. Mention your familiarity with ICH guidelines and any specific therapeutic areas you have experience in, such as oncology or auto-immune diseases.
How to prepare for a job interview at Syneos Health
✨Showcase Your Writing Skills
As a Senior Clinical Medical Writer, your writing skills are paramount. Bring samples of your previous work that demonstrate your ability to create clinical documents, such as study protocols and reports. Be prepared to discuss your writing process and how you ensure clarity and compliance with regulatory standards.
✨Understand Regulatory Guidelines
Familiarity with ICH-E3 guidelines and FDA regulations is crucial for this role. Brush up on these guidelines before the interview and be ready to discuss how you've applied them in your past projects. This will show your potential employer that you are well-versed in the necessary standards for medical writing.
✨Demonstrate Team Collaboration
This position requires interaction with various departments, so highlight your experience working in cross-functional teams. Share examples of how you've collaborated with data management, biostatistics, or regulatory affairs to produce high-quality deliverables. This will illustrate your ability to work effectively within a team.
✨Prepare for Technical Questions
Expect technical questions related to clinical research principles and document preparation. Review common challenges faced in medical writing and think about how you would address them. Being able to articulate your problem-solving approach will demonstrate your expertise and readiness for the role.
