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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
    Remote

AI generated summary

  • You need a relevant degree, strong writing skills, knowledge of FDA/ICH guidelines, proficiency in MS Office, and the ability to interpret clinical research data.
  • You will lead medical writing projects, mentor junior writers, develop clinical documents, coordinate across departments, review content for compliance, and maintain industry knowledge while managing budgets.

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 Sr Regulatory Medical Writer.

Is this position home-based?

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

What are the main responsibilities of the Sr Regulatory Medical Writer?

The main responsibilities include managing medical writing activities, developing various clinical documents, mentoring less experienced writers, conducting literature searches, and adhering to regulatory standards.

What qualifications are required for this position?

Candidates should have a Bachelor of Science or Bachelor of Arts degree, extensive knowledge of English grammar and FDA/ICH regulations, proficiency in Microsoft Office, and familiarity with clinical research principles.

Is experience in medical writing necessary for this role?

Yes, relevant writing experience is required, along with scientific and/or medical knowledge.

Will there be opportunities for career development?

Yes, Syneos Health is committed to developing its employees through career progression, training, and a supportive environment.

How does Syneos Health support a diverse workplace?

Syneos Health promotes a culture that embraces diversity of thoughts, backgrounds, cultures, and perspectives, creating a sense of belonging for all employees.

What types of documents will I be responsible for creating?

You will be responsible for creating clinical study protocols, clinical study reports, patient narratives, regulatory submissions, investigator brochures, and clinical journal manuscripts, among other documents.

Is travel required for this position?

Minimal travel may be required, specifically less than 25%.

What is the company culture like at Syneos Health?

The company culture is guided by the "Total Self" philosophy, encouraging employees to be their authentic selves while fostering growth and collaboration.

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.