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Principal Medical Writer (Regulatory Submissions)

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Syneos Health Commercial Solutions

14d ago

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

AI generated summary

  • You should have a BS or BA in relevant fields, strong writing skills, knowledge of FDA/ICH guidelines, proficiency in MS Office, and ability to interpret clinical data.
  • You will mentor writers, manage study documentation, ensure quality standards, advise clients, review content, conduct literature searches, and maintain budgets while adhering to regulatory guidelines.

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 with a familiarity with AMA style guide.
  • Understanding of FDA and ICH regulations and guidelines strongly preferred.
  • Demonstrated effective presentation, proofreading, and interpersonal 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.
  • Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
  • Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
  • Develops good working relationships with internal and external colleagues.
  • 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.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, 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.
  • Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
  • Understands 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 primary role of a Principal Medical Writer at Syneos Health?

The Principal Medical Writer is responsible for leading medical writing activities associated with individual studies, mentoring less experienced writers, and developing a variety of regulatory and clinical documents.

What qualifications are required for the Principal Medical Writer position?

Candidates should have a Bachelor of Science or Bachelor of Arts degree, relevant writing experience, extensive knowledge of English grammar, and familiarity with FDA and ICH regulations.

Is experience in clinical research necessary for this role?

Yes, familiarity with principles of clinical research and the ability to interpret and present clinical data is necessary for the position.

What types of documents will the Principal Medical Writer be expected to produce?

The role involves developing documents such as clinical study protocols, clinical study reports, IND submissions, NDA submissions, investigator brochures, and clinical journal manuscripts.

Will the Principal Medical Writer have the opportunity to mentor others?

Yes, the Principal Medical Writer is expected to mentor and lead less experienced medical writers on complex projects.

Is there a requirement for travel in this position?

Minimal travel may be required, with less than 25% of the job potentially involving travel.

What software skills are necessary for the Principal Medical Writer?

Strong proficiency in Microsoft Word, Excel, PowerPoint, email, and internet usage is required.

Are there opportunities for career development within Syneos Health?

Yes, Syneos Health is passionate about developing its employees through career progression, technical training, and peer recognition programs.

What is the company culture like at Syneos Health?

Syneos Health promotes a Total Self culture, encouraging employees to authentically be themselves, and focuses on diversity and inclusion to create a workplace where everyone feels they belong.

How does Syneos Health ensure quality in medical writing projects?

The Principal Medical Writer adheres to established regulatory standards, company SOPs, and client standards to maintain quality and meet client expectations in all writing projects.

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Syneos Health Commercial Solutions

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.