Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased
Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased

Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased

Full-Time 42000 - 84000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead and mentor medical writing projects, creating essential clinical documents.
  • Company: Syneos Health is a global biopharmaceutical solutions leader focused on accelerating customer success.
  • Benefits: Enjoy a supportive culture, career development opportunities, and a commitment to diversity.
  • Why this job: Make a real impact in healthcare while working 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: Remote work opportunity with minimal travel required.

The predicted salary is between 42000 - 84000 £ per year.

Senior Medical Writer – Sponsor Dedicated – Regulatory – United Kingdom, homebased

Join to apply for the Senior Medical Writer – Sponsor Dedicated – Regulatory – United Kingdom, homebased role at Syneos Health

Senior Medical Writer – Sponsor Dedicated – Regulatory – United Kingdom, homebased

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Join to apply for the Senior Medical Writer – Sponsor Dedicated – Regulatory – United Kingdom, homebased role at Syneos Health

Description

Senior Medical Writer – Sponsor Dedicated – Regulatory – United Kingdom, homebased

Description

Senior Medical Writer – Sponsor Dedicated – Regulatory – United Kingdom, 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.
  • 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. Minimal travel may be required (less than 25%).
  • Qualifications

    What we’re looking for

    • 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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    We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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    Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased employer: Syneos Health

    At Syneos Health, we pride ourselves on being an exceptional employer, offering a supportive and inclusive work culture that prioritises employee development and well-being. Our home-based roles provide the flexibility to balance personal and professional life while working alongside passionate colleagues dedicated to making a difference in biopharmaceutical solutions. With a commitment to career progression and a Total Self culture, we empower our employees to thrive and contribute meaningfully to our mission of accelerating customer success.
    S

    Contact Detail:

    Syneos Health Recruiting Team

    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 role 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 leadership experience and how you've mentored others, as this aligns with the responsibilities of the Senior Medical Writer role.

    Tip Number 4

    Showcase your proficiency in tools like Word, Excel, and PowerPoint by being ready to discuss how you've used these in past roles. Being able to articulate your technical skills will set you apart from other candidates.

    We think you need these skills to ace Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased

    Medical Writing Expertise
    Regulatory Knowledge (FDA, ICH)
    Strong English Grammar Skills
    Clinical Research Principles
    Document Development (Protocols, Reports, Submissions)
    Leadership and Mentoring Skills
    Interpersonal Communication
    Attention to Detail
    Project Management
    Proficiency in Microsoft Word, Excel, PowerPoint
    Ability to Interpret Clinical Data
    Familiarity with AMA Style Guide
    Problem-Solving Skills
    Time Management

    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 to the interview, especially documents like clinical study protocols or reports. Be prepared to discuss your writing process and how you ensure clarity and compliance with regulatory standards.

    Demonstrate Regulatory Knowledge

    Familiarity with FDA and ICH regulations is crucial for this role. Brush up on these guidelines before your interview and be ready to discuss how you've applied them in past projects. This will show that you understand the importance of adhering to regulatory standards in medical writing.

    Highlight Leadership Experience

    Since the role involves mentoring less experienced writers, be sure to highlight any leadership or mentoring experience you have. Share specific examples of how you've guided teams or individuals in previous roles, focusing on your ability to foster collaboration and support.

    Prepare for Technical Questions

    Expect technical questions related to clinical research principles and data interpretation. Review key concepts and be ready to explain how you would approach complex writing tasks. This will demonstrate your expertise and confidence in handling the responsibilities of the position.

    Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased
    Syneos Health
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    S
    • Senior Medical Writer - Sponsor Dedicated - Regulatory - United Kingdom, homebased

      Full-Time
      42000 - 84000 £ / year (est.)

      Application deadline: 2027-08-26

    • S

      Syneos Health

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