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Sr Regulatory Medical Writer (Home Based - Portugal/Spain/France/Belgium/Germany/Hungary)

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Barcelona

AI generated summary

  • You need a relevant Bachelor’s degree, writing experience, strong English skills, knowledge of FDA/ICH regulations, proficiency in MS Office, and familiarity with clinical research principles.
  • You will lead complex writing projects, mentor junior writers, develop regulatory documents, conduct literature searches, and collaborate across departments, ensuring adherence to standards and timelines.

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.

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%).

FAQs

Is this position remote or hybrid?

This position is home-based, allowing for remote work in Portugal, Spain, France, Belgium, Germany, or Hungary.

What is the main responsibility of a Sr Regulatory Medical Writer?

The main responsibility is to manage medical writing activities for clinical studies, including the development of various regulatory documents such as clinical study protocols, reports, and submissions.

What qualifications are required for this role?

A Bachelor's degree in a relevant field with significant writing experience or a degree in Social Sciences, English, or Communications with scientific and/or medical knowledge is required.

How much experience is expected for this position?

The job posting does not specify an exact number of years of experience, but extensive knowledge of medical writing and regulatory guidelines is essential.

Are there opportunities for career development at Syneos Health?

Yes, Syneos Health is committed to the career development and progression of its employees through various training, supportive management, and recognition programs.

Will I need to travel for this position?

Minimal travel may be required for this role, estimated at less than 25%.

What types of documents will I be expected to write?

You will write a variety of documents, including clinical study protocols, clinical study reports, IND submissions, NDA submissions, and clinical journal manuscripts, among others.

Is familiarity with regulatory guidelines necessary for this position?

Yes, extensive knowledge of FDA and ICH regulations, as well as familiarity with the AMA style guide, is crucial for this role.

Will I be mentoring other writers?

Yes, as a Senior Medical Writer, you will have the opportunity to mentor and lead less experienced medical writers on complex projects.

How does Syneos Health promote a diverse and inclusive workplace?

Syneos Health is dedicated to creating an inclusive environment by bringing together diverse thoughts, backgrounds, cultures, and perspectives, ensuring that everyone feels they belong.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only 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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.