Job title: Sr Medical Writer
Company: inVentiv Health Clinical SRE, LLC
Job description: Job Description : Senior Medical Writer Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with e
Job Description : Senior Medical Writer Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors. Why Syneos Health . #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference. . We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial. . 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 . 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: 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. . 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 We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.
Job date: Sat, 22 Jan 2022 23:54:31 GMT
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