Sr Medical Writer
2 weeks ago
Job Title Sr Medical Writer CSR IB Protocol Homebased India Job Location Gurugram Haryana IndiaJob Location Type RemoteJob Contract Type Full-timeJob Seniority Level Mid-Senior levelDescriptionSenior Medical WriterSyneos Healthxc2xae 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 youll 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 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 were 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 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 administrated tasks within the specified timeframes Performs other work-related duties as assigned Minimal travel may be required less than 25 QualificationsWhat were 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 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 youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health Additional InformationTasks 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 Lifelancer is a talent-hiring platform in Life Sciences Pharma and IT The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains For more details and to find similar roles please check out the below Lifelancer link Lifelancer
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