Sr Medical Writer (Narratives) - Homebased (UK, Serbia, Romania, Poland, Greece, Hungary, Franc[...] Lisboa

Overview

Sr Medical Writer (Narratives) - Homebased (UK, Serbia, Romania, Poland, Greece, Hungary, France, Portugal, Spain) at Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. This role involves leading and delivering medical writing deliverables for clinical studies in a homebased capacity.

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 activities within and across departments with minimal supervision. Develops or supports a variety of documents, including clinical study protocols and amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and e
  CTD submissions; investigator brochures; and clinical journal manuscripts, abstracts, and client presentations.
• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Interacts with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review teams, providing review comments on draft and final documents.
• Adheres to regulatory standards (ICH-E3), SOPs, client standards, and approved templates; ensures
  - time and
  - budget delivery.
• Performs online clinical literature searches as applicable and stays familiar with current industry practices and regulatory guidelines.
• Maintains awareness of budget specifications for assigned projects and communicates changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other
  - related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

• 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.
• Extensive knowledge of English grammar and FDA and ICH regulations/guidelines; familiarity with AMA style guide.
• Demonstrated independence with effective presentation, proofreading, interpersonal, and leadership skills;
  - oriented approach.
• Strong proficiency in Word, Excel, Power
  Point, email, and Internet.
• Ability to interpret and present clinical data and other complex information.

About 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.