Description

Senior Principal Medical Writer

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:

• The Associate Director, Principal Medical Writer II is responsible for the development of clinical documents for submissions to regulatory authorities globally.  Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements.  
• Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation.  
• Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents.
• Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers.  Reports to a Director of Medical Writing or above.
• Provides support, training and consultation to department and other company employees as needed.
• Serves as a subject matter expert and contributes to the development of training materials and presentations on key topics where appropriate.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
• Advises 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.
• Develops good working relationships with internal and external colleagues.
• Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs/compounds.
• Develops or supports 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.

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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 with a familiarity with AMA style guide. 
*    Must have led, managed, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs/compounds.
*  We are looking for an experienced person to be the Medical Writing submission lead for one of our client's oncology programs to coordinate all planning and oversight of medical writing activities. Experience being the medical writing lead for submissions (NDA, BLA, MAA, etc); writing clinical summary documents (2.7.3/ISE, 2.7.4/ISS, Clinical Overview), CSRs, briefing books and responses; and experience in oncology is required. The person can be based in the US or Europe.

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Demonstrated effective presentation, proofreading, and interpersonal, 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.