Syneos Health is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. With over 29,000 employees across 110 countries, we specialize in integrating clinical development, medical affairs, and commercial insights to deliver groundbreaking therapies. Syneos Health is passionate about creating a workplace where employees thrive through innovation, collaboration, and career development.
Responsibilities in the Role
As a Medical Writer II, you will play a pivotal role in producing high-quality medical writing deliverables. Key responsibilities include:
- Document Creation: Develop clinical study protocols, reports, patient narratives, investigator brochures, and other essential documents.
- Mentorship: Guide less experienced medical writers on projects.
- Review and Editing: Ensure clarity, consistency, and adherence to regulatory guidelines in all writing assignments.
- Collaboration: Work closely with teams in data management, biostatistics, regulatory affairs, and medical affairs to deliver exceptional content.
- Peer Review: Participate in internal reviews, addressing feedback to maintain document integrity.
- Research: Conduct clinical literature searches to support document development.
- Regulatory Compliance: Adhere to ICH-E3 guidelines, company SOPs, and client standards.
- Budget Management: Work within allocated project budgets, communicating changes as needed.
Qualifications Required
To excel in this role, you should possess:
- A Bachelor of Science or Bachelor of Arts degree (preferably in English, Communications, or Social Sciences) with relevant medical writing experience.
- Proficiency in English grammar and familiarity with FDA, ICH regulations, and AMA style guidelines.
- Strong skills in Microsoft Word, Excel, PowerPoint, and Internet research.
- Knowledge of clinical research principles and the ability to interpret complex clinical data.
- Effective leadership, proofreading, and presentation skills.
Desired Skills and Attributes
- High degree of independence and a team-oriented approach.
- Passion for continuous professional development to stay updated with regulatory changes.
- Exceptional attention to detail and commitment to meeting deadlines.
Why Join Syneos Health?
At Syneos Health, we prioritize our people and their development. Here’s why you should consider joining us:
- Career Growth: Opportunities for professional advancement and skill development.
- Supportive Culture: A Total Self culture that values diversity and inclusivity.
- Industry Leadership: Work with a company that has collaborated on 94% of FDA-approved drugs over the past five years.
