Sr Medical Writer (Regulatory)

Updated: August 20, 2024Location: Brazil-Latin America - BRA-Home-BasedJob ID: 24004552Syneos 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 EVERYWHEREWhy Syneos HealthWe 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 ResponsibilitiesMentors 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:Clinical study protocols and clinical protocol amendments;Clinical study reports;Patient narratives;Clinical development plans;IND submissions and annual reports;Integrated summary reports;NDA and (e)CTD submissions;Investigator brochures;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 administrative tasks within the specified timeframes.Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).QualificationsWhat we're looking forBachelor 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 HealthOver 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.At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.Syneos Health is a leading 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
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