Medical Writer Ii

Updated Yesterday Location Pune MH India Job ID 25102321 Description Medical Writer II CSR Narratives 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 youa 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 a 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 a wea re able to create a place where everyone feels like they belong Job Responsibilities a Mentors less experienced medical writers on projects as necessary a Compiles writes and edits medical writing deliverables and serves as a medical writer within and across departments with minimal supervision a Develops or supports a variety of documents that include but not limited to o Clinical study protocols and clinical study protocol amendments o Clinical study reports o Patient narratives o Annual reports o Investigator brochures a Reviews statistical analysis plans and table figure listing specifications for appropriate content and for grammar format and consistency a Interacts with department head and staff members in data management biostatistics regulatory affairs and medical affairs as necessary to produce writing deliverables a Serves as peer reviewer on internal review team Addresses team comments accurately to ensure document scientific content clarity overall consistency and proper format a 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 a Performs on-line clinical literature searches as applicable a Working knowledge of drug development process and regulatory guidelines a Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing a Stays aware of budget specifications for assigned projects working within the budgeted hours and communicating changes to medical writing leadership a Completes required administrated tasks within the specified timeframes a Performs other work-related duties as assigned a Minimal travel may be required less than 25 Qualifications - External What wea re looking for Should have Min 1 years of experience working in narratives with masters qualification and 2 years experience with Graduation Must have good experience in drafting and reviewing narratives a Should be a Postgraduate Masters Mpharm or bachelora s degree a Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide a Demonstrated high degree of independence with effective presentation proofreading interpersonal and leadership skills and ensure a team-oriented approach a Strong proficiency in Word Excel PowerPoint email and Internet a 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 youa 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 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 Share this job