Sr Medical Writer (Clinical and Device Experience)

Syneos Health, Inc.; Barcelona; A distancia; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior Medical Writer to lead complex writing projects. In this role, you'll mentor junior writers and manage medical writing activities for clinical studies. Your expertise in FDA regulations and clinical research will be key as you develop essential documents like clinical study protocols and reports. Join a dynamic team dedicated to delivering impactful therapies and making a difference in patients' lives. This position offers a supportive environment that values career development and a culture of authenticity, ensuring you can thrive while contributing to meaningful projects.

Servicios

Career Development Opportunities

Engaged Line Management

Technical and Therapeutic Area Training

Peer Recognition Programs

Total Rewards Program

Formación

• Bachelor's degree in relevant field with writing experience.
• Extensive knowledge of FDA and ICH regulations.
• Strong proficiency in Microsoft Office tools.

Responsabilidades

• Mentors less experienced medical writers on projects.
• Manages medical writing activities with minimal supervision.
• Develops clinical study documents and reports.

Conocimientos

Medical Writing

English Grammar

FDA Regulations

ICH Guidelines

Presentation Skills

Interpersonal Skills

Leadership Skills

Educación

Bachelor of Science

Bachelor of Arts (Social Sciences, English or Communications)

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Email

Internet Research

Descripción del empleo

Sr Medical Writer (Clinical and Device Experience)

Updated : March 21, 2025

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

Job ID : 25002436

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 not only make Syneos Health easier to work with, but 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 to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job 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;
• 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%).

Qualifications

What we’re looking for

• 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.