Medical Writer II (Lay Summaries/Plain Language Summaries)

Description

Medical Writer II

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 Summary

Serves as medical writer on Lay Trial documents project teams. Writes, edits, perform quality checks (QC), and coordinates the preparation of lay documents with dependent staff roles to ensure satisfactory completion of all writing projects. A level of client interaction is expected.

Skills Requirements

• Minimum 2 years of regulatory writing experience, preferable with clinical study reports (CSRs)
• Preferable experience writing Lay Summaries/Plain Language Summaries or other patient facing documents, such as Lay Protocol Synopsis (LPS), Informed Consent Forms (ICFs), Patient information leaflets (PIL)
• Good in English Verbal/ Writing skills.
  
  

Job Responsibilities

• Compiles, writes, and edits LS deliverables, and serves as a medical writer within and across programs with minimal supervision.
• Develop a variety of plain language documents such as 2-page protocol lay summary, plain language summary of publications, and other patient-facing materials.
• Interacts with the Sponsor clinical teams and LS Specialist as necessary to produce LS deliverables, coordinate review cycles, attend and run kick-off meetings, and create and track timelines.
• Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
• Adheres to health literacy, and numeracy and readability principles to produce deliverables that are understood by the general public.
• Serves as QC reviewer on internal QC reviews.
• May support with preparation of a variety of documents that include but not limited to:
• Clinical study protocols and clinical study protocol amendments;
• Clinical study reports;
• Patient narratives;
• Investigator brochures.
• Adheres to established regulatory standards, including but not limited to ICH 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.
• Working knowledge of drug development process and regulatory guidelines.
• Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing.
• Stays aware 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 EMA, 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.

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.

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