Description

Principal Medical Writer

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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.
  

Our Medical Writing team here at Syneos Health provide expertise in Regulatory writing, Publishing and Editing, We are looking for a highly experienced Principal Medical Writer to join our collaborative team and contribute to our ongoing success.

Job responsibilities include:
• Mentoring and leading less experienced medical writers on complex projects
• Representing the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to clients regarding a writing project.
• Advising clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
• Developing good working relationships with internal and external colleagues.
• Managing medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Developing or supporting a variety of documents that include but not limited to:
o Clinical study protocols and clinical protocol amendments;
o Clinical study reports;
o Patient narratives;
o Clinical development plans;
o IND submissions and annual reports;
o Integrated summary reports;
o NDA and (e)CTD submissions;
o Investigator brochures, as well as;
o Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Serving as peer reviewer to ensure that client objectives are met and overall quality standards are maintained.
• Understanding budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

Some 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.
• Previous significant experience of writing complex regulatory documents, or previous experience writing publications, abstracts, posters etc.
• Ideally, disease area experience within Oncology, Diabetes or Neuroscience
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information style guide.
• Extensive knowledge of English grammar with a familiarity with AMA style guide.
• Understanding of FDA and ICH regulations and guidelines strongly preferred.
• Demonstrated effective presentation and proofreading skills and a team-oriented, collaborative approach.

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.