Syneos Health Hyderabad Hiring Senior Medical Writers

Syneos Health Hyderabad Hiring Senior Medical Writers

18 February, 2022

About the job

Job Summary

Serves as a senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory while serving as primary technical contact with the internal team and the client.

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, as well as;
  • 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%).

Qualification Requirements

  • 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.

Qualification Requirements

  • 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.

How to Apply?

Apply through below link

https://www.linkedin.com/jobs/view/2862090247/?alertAction=markasviewed&savedSearchAuthToken=1%26AQHC9IF-HdFDAwAAAX8KPZvbGBle9LAJG6ldFLp3vdCsIhuDBcRRSfbDhUMO7Wr3v26Wo5N-l88UaVZ3U8h7WrjA9Vhzh3SYsu38tlsd7at-PlRUQGeQDA6Qqr94zeUSsjU8NocsO8DID-q9FAUMLggkBGag4pNPsWbvSC69ATwMiAnFvjCPC7WbjaHPOPGeMS5wqBA1LueXMGzPzMK3MyXqTHb6cvdoW0xgtqXFmnlYgFJEG57zjGusMCkmqYMt-S0nsYI4vflcaGSKglU0BOQNIrFhtSvYeuhRAeEppd-Ki1koXU54Vgs%26AfBAbJMjZN6Wqr3mPZhpfTasKfAW&savedSearchId=1495604186&refId=517a39b6-9f77-4305-8165-a8e9af20f725&trackingId=eGqdPFyTBMTMnDXKjbPTKg%3D%3D&midToken=AQHe5DI7JhynNA&midSig=3nMaexj0O_oq81&trk=eml-email_job_alert_digest_01-job_alert-8-member_details_mercado&trkEmail=eml-email_job_alert_digest_01-job_alert-8-member_details_mercado-null-zetr5%7Ekzrofhat%7Eyy-null-jobs%7Eview

Primary Location

Asia Pacific – IND-Hyderabad-DLF-Cybercity

Job

Medical Writing

Schedule

Full-time

Travel

No

Employee Status

Regular

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