Regulatory Medical Content Specialist

5 days ago


Dublin, Dublin City, Ireland Syneos Health, Inc. Full time

Company Overview

Syneos Health, Inc. is a leading biopharmaceutical solutions organization dedicated to accelerating 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 we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

Job Description

We are seeking a Principal/Sr Regulatory Medical Writer to join our team. As a key member of our team, you will mentor and lead less experienced medical writers on complex projects, act as a lead for assigned writing projects, and manage medical writing activities associated with individual studies.

You will develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, integrated summary reports, NDA and eCTD submissions, investigator brochures, clinical journal manuscripts, clinical journal abstracts, and client presentations.

Your responsibilities will include identifying and proposing solutions to resolve issues and questions arising during the writing process, reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and interacting with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.

You will serve as a peer reviewer on internal review teams, providing review comments on draft and final documents, adhere to established regulatory standards, maintain familiarity with current industry practices and regulatory requirements and guidelines, and perform online clinical literature searches as applicable.

Required Skills and Qualifications
  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications) 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.
Benefits

We offer a total rewards package that reflects our commitment to developing our people and creating a workplace where everyone feels like they belong. This includes career development opportunities, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.



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