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

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

AI generated summary

  • You must have a relevant Bachelor's degree, strong writing and grammar skills, knowledge of FDA/ICH guidelines, proficiency in MS Office, and the ability to interpret clinical data.
  • You will lead writing projects, mentor junior writers, develop various clinical documents, ensure compliance with regulations, collaborate across teams, and manage project budgets while maintaining industry knowledge.

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

What is the job title for this position?

The job title is Senior Regulatory Medical Writer.

Where is this job located?

This position is home-based and available in Portugal, Spain, France, Belgium, Germany, and Hungary.

What is the primary responsibility of a Senior Regulatory Medical Writer at Syneos Health?

The primary responsibility includes managing medical writing activities associated with clinical studies and developing various types of clinical documents.

What kind of documents will I be responsible for writing?

You will be responsible for writing clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, NDA submissions, investigator brochures, and more.

What qualifications are required for this position?

A Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree in Social Sciences, English, or Communications, along with relevant scientific and/or medical knowledge is required.

Is there a requirement for prior experience?

Yes, extensive knowledge of English grammar, FDA and ICH regulations, and experience in medical writing are necessary for this role.

Will I need to travel for this job?

Minimal travel may be required, estimated to be less than 25%.

What skills are essential for this position?

Essential skills include effective presentation, proofreading, interpersonal and leadership skills, as well as strong proficiency in Word, Excel, PowerPoint, and internet tools.

Is there an emphasis on teamwork in this role?

Yes, a team-oriented approach is important, and mentoring less experienced medical writers is a responsibility of this position.

What is Syneos Health's commitment to employee development?

Syneos Health is passionate about developing its people through career development opportunities, supportive management, training, and a recognition program.

What is the company's stance on diversity and inclusion?

Syneos Health is committed to creating a diverse and inclusive workplace where everyone feels they belong, by valuing diverse thoughts, backgrounds, cultures, and perspectives.

Are there specific regulatory standards I need to adhere to?

Yes, you need to adhere to established regulatory standards, including ICH-E3 guidelines, company SOPs, and client standards during medical writing projects.

Will my prior experience be considered even if it doesn't exactly match the qualifications?

Yes, equivalent experience, skills, and education will be considered, as the company has the discretion to determine qualifications.

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.