Job Description

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. JOB SUMMARY Provides scientific writing, regulatory guidance and technical expertise in the writing, production, and review of high quality Lay Summaries (LS), regulatory and other scientific/clinical documents ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines. Skills Requirements: Minimum 8 years of regulatory writing experience. Experience in writing patient facing documents such as Informed Consent form (ICF) , patient information Leaflets (PIL), or safety reports (DSURs, PSURs) with exposure to PLS writing preferred . Excellent in English Verbal/ Writing skills. JOB RESPONSIBILITIES Serves as peer reviewer and mentor for junior LS writers, providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained. Reviews source documents for appropriateness in terms of data presentation and compliance with minimal regulatory disclosure requirements. Leads patient or lay review panels to collate feedback on LSs and relay findings back to the Sponsor. Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding writing projects. 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. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Mentors and leads less experienced medical writers on complex LS projects, as necessary. 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 o Clinical journal manuscripts, including plain language summary of publications, clinical journal abstracts, and client presentations. Adheres to established regulatory standards, including but not limited to ICH guidelines, as well as company SOPs, 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. Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills. Understands 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 QUALIFICATION REQUIREMENTS .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. .Understanding of FDA and ICH regulations and guidelines strongly preferred. .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. Disclaimer: 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 . 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.

foundit