Medical Writer I
Company: Syneos Health
Location: [Location not specified]
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. With 29,000 employees across 110 countries, Syneos Health delivers innovative solutions that address the evolving market realities of the healthcare and biopharmaceutical industries.
"Work Here Matters Everywhere"
Why Syneos Health?
At Syneos Health, we are committed to the professional development and career progression of our employees. We offer a supportive and inclusive work environment where individuals can thrive while contributing to impactful healthcare innovations.
Role Overview
As a Medical Writer I, you will work under moderate supervision to compile, write, and edit medical documents in compliance with regulatory standards. This role will involve developing a variety of documents, such as clinical study protocols, clinical study reports, investigator brochures, and patient narratives. You will collaborate with cross-functional teams in areas such as data management, biostatistics, regulatory affairs, and medical affairs to ensure the timely and accurate delivery of medical writing projects.
Key Responsibilities
Medical Writing & Documentation:
Write and edit a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and investigator brochures.
Review statistical analysis plans and provide feedback on the statistical output required, ensuring alignment with project goals and grammar consistency.
Conduct online clinical literature searches and compile relevant findings to support documentation.
Ensure adherence to regulatory guidelines such as ICH-E3 and company templates while completing medical writing projects within scope, on time, and on budget.
Collaboration & Communication:
Work with cross-departmental teams, including data management, biostatistics, regulatory affairs, and medical affairs, to ensure the quality of medical writing deliverables.
Provide feedback and suggestions to improve writing and ensure consistency across documents.
Participate in team meetings and contribute to the development of writing standards and processes.
Compliance & Quality Control:
Follow established regulatory standards and company SOPs in all writing tasks.
Maintain awareness of current regulatory guidance and client expectations to ensure medical writing is compliant with applicable standards.
Contribute to the budgeting process by adhering to project hours and communicating any required adjustments.
Perform proofreading, editing, and quality checks to ensure clarity, accuracy, and proper formatting of all written materials.
Continuous Learning & Development:
Pursue professional development opportunities to stay up-to-date with evolving regulatory guidance and improve writing skills.
Participate in internal and external training to enhance medical writing expertise.
Qualifications
Education & Experience:
Bachelor of Science in a relevant field (e.g., life sciences) with experience in medical writing, or a Bachelor of Arts degree (Social Sciences, English, Communications) with scientific or medical knowledge and writing expertise.
Strong understanding of FDA and ICH regulations and guidelines, with knowledge of clinical research principles.
Experience in developing and writing scientific documents for clinical trials or medical studies is preferred.
Skills & Competencies:
Excellent English grammar skills with familiarity with AMA style guide.
Strong proofreading, presentation, and interpersonal communication skills.
Proficiency with Microsoft Word, Excel, PowerPoint, email, and internet tools.
Ability to interpret and present clinical data and complex information effectively.
Why Work with Us?
Career Growth: We provide extensive opportunities for career development and professional growth.
Collaborative Culture: At Syneos Health, we believe in fostering a culture where employees are empowered to be their authentic selves and contribute to our mission of improving healthcare.
Global Impact: As part of Syneos Health, you'll contribute to the development of life-changing therapies that improve patient outcomes across the globe.
Apply Now to join Syneos Health, where you can grow your career while making a tangible difference in the lives of patients.
Syneos Health is committed to building a diverse, inclusive, and authentic workplace. We encourage individuals from all backgrounds to apply, and we value transferable skills. Join our Talent Network to stay connected to additional career opportunities.
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