Single Sponsor Principal / Sr Medical Writer - Spain, Poland, Ireland, Netherlands, France, UK,[...]

Syneos Health, Inc.; Madrid; Presencial; EUR 50.000 - 90.000; Jornada completa

Descripción de la vacante

An established industry player seeks a Senior Medical Writer with expertise in regulatory submissions and clinical documentation. In this pivotal role, you will lead writing projects, mentor junior writers, and ensure compliance with regulatory standards. You will collaborate with cross-functional teams to produce high-quality clinical documents that drive the success of innovative therapies. If you have a passion for medical writing and a desire to make a difference in patients' lives, this opportunity is perfect for you. Join a dynamic team dedicated to advancing healthcare solutions and enhancing patient outcomes.

Formación

• Bachelor's degree with relevant writing experience or preferred in Social Sciences, English, or Communications.
• Experience in a Senior/Principal Clinical Writing role for a CRO or Pharma, leading submissions.
• Strong proficiency in English grammar and familiarity with FDA and ICH regulations.

Responsabilidades

• Lead and manage medical writing activities for clinical studies and submissions.
• Mentor less experienced writers and ensure adherence to regulatory standards.
• Develop a variety of clinical documents including study protocols and reports.

Conocimientos

Medical Writing

Regulatory Submissions

Clinical Protocols

English Grammar

Interpersonal Skills

Leadership Skills

Educación

Bachelor of Science

Bachelor of Arts (Social Sciences, English or Communications)

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descripción del empleo

Single Sponsor Principal / Sr Medical Writer - Spain, Poland, Ireland, Netherlands, France, UK, Switzerland, Belgium, Italy, US, and Canada. Must have lead submissions experience.

Updated : December 12, 2024

Location : Spain-Europe - ESP-Home-Based (Madrid)

Job ID : 24006479

Syneos Health is a leading 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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Job responsibilities

1. Mentor and lead less experienced medical writers on complex projects, as necessary.
2. Act as lead for assigned writing projects and submissions.
3. Manage medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision.
4. Develop or support a variety of documents, including:

• Clinical study protocols and amendments;
• Clinical study reports;
• IND submissions and annual reports;
• Integrated summary reports;
• NDA and (e)CTD submissions;
• Investigator brochures;
• Clinical journal manuscripts, abstracts, and client presentations.

Identify and propose solutions to resolve issues during the writing process, including escalation as appropriate. Review statistical analysis plans and specifications for content, grammar, format, and consistency. Interact with data management, biostatistics, regulatory affairs, and medical affairs teams to produce deliverables. Serve as peer reviewer on internal review teams. Adhere to regulatory standards, including ICH-E3 guidelines, SOPs, client standards, and approved templates. Perform online literature searches and stay updated on industry practices and regulatory guidelines. Maintain awareness of project budgets and communicate any changes.

Qualifications

1. Bachelor of Science degree with relevant writing experience or Bachelor of Arts in Social Sciences, English, or Communications with scientific/medical knowledge.
2. Experience in a Senior/Principal Clinical Writing role within a CRO or Pharma, with lead submission experience.
3. Proficiency in all Clinical and Regulatory documents required for this role.
4. Extensive knowledge of English grammar, FDA and ICH regulations, and familiarity with AMA style guide.
5. High degree of independence, with effective presentation, proofreading, interpersonal, and leadership skills. Team-oriented approach.
6. Proficiency in Word, Excel, PowerPoint, email, and Internet.
7. Ability to interpret and present clinical data and complex information.

Additional Information :

Tasks, duties, and responsibilities may be expanded at the company's discretion. Equivalent experience, skills, or education will also be considered.

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