Sr Medical Writer (Drug Experience)

Syneos Health, Inc.; Valencia; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A biopharmaceutical solutions organization is seeking a skilled medical writer to manage multiple deliverables and regulatory documents. Ideal candidates must have a Bachelor's degree and strong knowledge of FDA regulations. This role offers opportunities for growth within a collaborative global team. Committed to diversity and inclusion, the organization encourages applicants from various backgrounds to apply.

Servicios

Career progression

Diversity and inclusion initiatives

Formación

• Experience with regulatory documents.
• Proficient in data interpretation skills.
• Familiarity with clinical research principles.

Responsabilidades

• Mentor and lead junior medical writers.
• Manage medical writing for studies.
• Review and ensure compliance with regulatory standards.

Conocimientos

Independent with leadership skills

Strong English grammar knowledge

Knowledge of FDA and ICH regulations

Presentation and proofreading skills

Educación

Bachelor's degree in Science or Arts

Herramientas

Microsoft Word

Microsoft Excel

PowerPoint

Descripción del empleo

Updated : Yesterday

Location : ESP-Remote (Madrid)

Job ID : 25100072

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 places the customer and patient at the center of our work. We aim to simplify and streamline processes to make working with us easier for clients and employees alike.

Whether in a Functional Service Provider partnership or a Full-Service environment, our teams collaborate passionately to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing 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 progression, supportive management, training, peer recognition, and rewards.
• We foster a Total Self culture where you can be authentic. We are committed to caring for our people and promoting diversity of thought, background, and culture.

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Act as lead for assigned writing projects.
• Manage medical writing activities for individual studies, coordinating across departments, including developing various documents such as clinical protocols, reports, IND submissions, and manuscripts.
• Identify and resolve issues during the writing process, escalate when necessary.
• Review statistical plans and specifications for content, grammar, and consistency.
• Collaborate with data management, biostatistics, regulatory, and medical affairs teams to produce deliverables.
• Serve as peer reviewer for draft and final documents.
• Adhere to regulatory standards and company SOPs, ensuring timely and within-budget delivery.
• Perform literature searches and stay updated on industry practices and regulations.
• Maintain awareness of project budgets and communicate changes.
• Complete administrative tasks within deadlines. Minimal travel may be required.

Qualifications

• Bachelor's degree in Science or Arts with relevant writing and scientific/medical knowledge.
• Strong knowledge of English grammar, FDA, ICH regulations, and AMA style.
• Independent with excellent presentation, proofreading, interpersonal, and leadership skills.
• Proficient in Word, Excel, PowerPoint, email, and Internet.
• Familiarity with clinical research principles and data interpretation skills.

Get to know Syneos Health

Over the past 5 years, we’ve worked with 94% of FDA-approved drugs, 95% of EMA products, and over 200 studies worldwide.

Join us in a dynamic environment where initiative and innovation are valued. Learn more about us.

Additional Information

Responsibilities may include other tasks as assigned. Qualifications may be considered transferable. We comply with all applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, providing accommodations as needed.

Summary

Seeking a skilled medical writer with experience in regulatory documents, capable of managing multiple deliverables and working in a global team. Opportunities for growth and development are available.

Syneos Health is committed to diversity, inclusion, and authenticity. We encourage applicants with diverse backgrounds to apply and join our Talent Network.

Discover why our employees say: work here matters everywhere. We are dedicated to delivering therapies that improve patients’ lives worldwide. A career with us guarantees meaningful work and professional growth.

Syneos Health (Nasdaq: SYNH) is a leading biopharmaceutical solutions organization committed to accelerating customer success through innovative practices, diverse teams, and a shared commitment to improving health outcomes.

Phone : [phone]

Fax : [phone]

Toll-Free : 866 462 7373

We are an Equal Opportunity Employer. All qualified applicants will be considered without discrimination. For accommodations, contact us via email.

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