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Principal Medical Writer

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Syneos Health Commercial Solutions

2mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Science
    Research & Development
  • Madrid

AI generated summary

  • You need a relevant Bachelor’s degree, strong writing and grammar skills, knowledge of FDA/ICH guidelines, proficiency in MS Office, and the ability to present clinical data effectively.
  • You will mentor writers, manage medical writing projects, review documents, liaise with clients, ensure quality standards, conduct literature searches, and adhere 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 main responsibility of a Principal Medical Writer at Syneos Health?

The main responsibility includes managing medical writing activities associated with individual studies, mentoring less experienced medical writers, and developing a variety of crucial documents such as clinical study protocols, clinical study reports, and regulatory submissions.

What qualifications are required to apply for the Principal Medical Writer position?

Candidates should have a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree (in Social Sciences, English, or Communications) with relevant scientific and/or medical knowledge. Extensive knowledge of English grammar and familiarity with the AMA style guide are also required.

What skills are essential for a Principal Medical Writer?

Essential skills include effective presentation abilities, proofreading and interpersonal skills, strong proficiency in Microsoft Word, Excel, PowerPoint, email, and the Internet, as well as familiarity with clinical research principles and the ability to interpret complex clinical data.

Is knowledge of FDA and ICH regulations necessary for this role?

Yes, an understanding of FDA and ICH regulations and guidelines is strongly preferred for the Principal Medical Writer position.

How much travel is expected in this role?

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

What opportunities for professional development are provided?

Syneos Health is committed to the continuous professional development of its employees and provides various training programs, career development opportunities, and peer recognition.

Does Syneos Health promote a diverse work culture?

Yes, Syneos Health is dedicated to building a diverse and inclusive workplace where different thoughts, backgrounds, cultures, and perspectives are valued.

Will the Principal Medical Writer be involved with clients?

Yes, the Principal Medical Writer will represent the Medical Writing department on clinical study teams and present to clients regarding writing projects.

Are there specific documents that the Principal Medical Writer will work on?

Yes, the Principal Medical Writer will develop and support documents such as clinical study protocols, clinical study reports, IND submissions, NDA submissions, and clinical journal manuscripts, among others.

What is the company culture like at Syneos Health?

The company culture at Syneos Health focuses on a Total Self culture where employees can authentically be themselves, emphasizes career development, and promotes a sense of belonging among all employees.

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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.