Syneos Health recruiting Senior Medical Writer

Syneos Health recruiting Senior Medical Writer

29 March, 2022

Job Summary

Description

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.

Qualifications

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.

Apply through below link:

https://www.linkedin.com/jobs/view/2990507075/?alertAction=markasviewed&savedSearchAuthToken=1%26AQEdSzjNmnnEwwAAAX_VhaTQxn8RWgHGunR1QnLp38VHX2QVPlTHrdKyDo9aqxRv5_acNo-g_0Q-WnvIFP-QdLVS7U-mMawWlR9za1NaEQ-J1sGUoqGbov_TOjrf5wALJ25DCravmTulUy8Nvy8jLnJiYT5dGDqj7axDglB-WO21RiNGAo7HU-fxB-p46I5K5VQ51G0971rD2Rc7YsDO_rn8WuJVxodBlMX6nEijIVCaQ6nOMD0mS_2OSbkGQ4NnYdEyLd6L2wSfsPOcrjhLqBuJ_Y-V4xc3sFEG9w1uQAnes4AKoAy9QkI%26Af7aD0_SLkxIRqhmZ4nXPZveOghX&savedSearchId=1495604186&refId=0861e4b8-c758-4733-b817-71020eebb46d&trackingId=q0vk1gvuq14Avxe6Ary2KQ%3D%3D&midToken=AQHe5DI7JhynNA&midSig=2_CJ_-QiT8fWc1&trk=eml-email_job_alert_digest_01-job_alert-9-member_details_mercado&trkEmail=eml-email_job_alert_digest_01-job_alert-9-member_details_mercado-null-zetr5%7El1c2y8vo%7Epg-null-jobs%7Eview

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