Updated Yesterday Location Gurgaon HR India Job ID 25104299-OTHLOC-5206-2DH Description Senior 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 up-to-date 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 Leads the clear and accurate completion of medical writing deliverables ensuring scientific information is presented clearly and accurately Manages medical writing activities associated with individual studies coordinating medical writing activities within and across departments with minimal supervision Leads the resolution of comments from the client Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments clinical study reports patient narratives annual reports investigator brochures informed consents annual reports plain language summaries periodic safety update reports clinical development plans IND submissions integrated summary reports NDA and eCTD submissions journal manuscripts and abstracts posters and presentations for scientific meetings 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 authorship requirements and style and formatting guides when completing medical writing projects on time and on budget Coordinates quality and editorial reviews Ensures source documentation is managed appropriately Leads team document reviews and reviews documents as needed Acts as peer reviewer for internal team to ensure document scientific content clarity overall consistency and proper format Reviews statistical analysis plans and table figure listing specifications for appropriate content and for grammar format and consistency Provides feedback to further define statistical output required and document needs Interacts and builds good working relations with clients department head and peers in data management biostatistics regulatory affairs and medical affairs as necessary to produce writing deliverables Performs online clinical literature searches and complies with copyright requirements Identifies and proposes solutions to resolve issues escalating as appropriate Provides technical support training and consultation to department and other company staff May contribute to development of internal materials and presentations or changes to internal process standard practices and capabilities Mentors and leads less experienced medical writers on complex projects as necessary Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing Aware of budget specifications for assigned projects working within the budgeted hours and communicating status and 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 Qualifications 3-5 years of relevant experience in science technical or medical writing Experience working in the biopharmaceutical device or contract research organization industry required Strong understanding of FDA and ICH regulations other regulatory guidelines and or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly strong familiarity with AMA Manual of Style 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 Summary Roles within the Medical Writing job family are responsible for writing and editing manuscripts and other medical communications on clinical studies and or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use monographs comprehensive reviews scientific exhibits and other projects requiring skill in medical communication such as screening analyzing and summarizing additional data from other sources as needed Conducts systematic literature searches and reviews Prepares literature for new products and revises existing medical communication Reviews and analyzes statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports Supports engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty but may manage two or fewer employees May direct the work of lower level professionals or manage processes and programs The majority of time is spent contributing to the design implementation or delivery of processes programs and policies using knowledge and skills typically acquired through advanced education Individual contributor with developing subject matter expertise and responsibility for processes In-depth knowledge and skills within a professional discipline understanding the impact of work on related areas May be responsible for entire projects or processes within area of responsibility Share this job

📌 Senior Medical Writer (Gurugram)
🏢 Syneos Health
📍 Gurugram