Regulatory Principal Medical Writer - USA - West Coast, Canada - MedStar Health : Job Details

Principal Medical Writer (Regulatory)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical affairs, and commercial insights into tangible outcomes to meet modern market needs.

Our Clinical Development model centers on the customer and patient, continually seeking to simplify and streamline our processes. Whether in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers to help our clients achieve their goals. We are agile and committed to accelerating therapy delivery because we are passionate about changing lives.

Join our team of 29,000 employees across 110 countries and discover why:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We invest in our people through career development, supportive management, training, peer recognition, and comprehensive rewards.
• Our Total Self culture encourages authenticity and takes care of our employees.
• We foster diversity of thought, backgrounds, and perspectives to create an inclusive environment where everyone belongs.

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Represent the Medical Writing department on clinical study teams, conferences, and client presentations.
• Advise clients and study teams on data presentation strategies, ensuring quality and client objectives are met.
• Develop and manage medical writing activities for individual studies, coordinating across departments.
• Create various documents including clinical protocols, reports, narratives, development plans, submissions, and manuscripts.
• Review statistical analysis plans and specifications for content, grammar, and consistency.
• Provide peer review to ensure clarity, accuracy, and quality standards.
• Adhere to regulatory standards, SOPs, templates, and deadlines.
• Perform literature searches and keep up-to-date with regulatory guidance.
• Understand and work within project budgets, communicating any changes.
• Complete administrative tasks timely; minimal travel may be required.

Qualifications

• Bachelor of Science or Arts with relevant experience or scientific/medical knowledge.
• Strong knowledge of English grammar and AMA style.
• Understanding of FDA and ICH regulations preferred.
• Effective presentation, proofreading, and interpersonal skills.
• Proficiency in Word, Excel, PowerPoint, email, and internet.
• Ability to interpret and present clinical data.

We offer benefits including a company car or allowance, health coverage, 401k matching, stock purchase plans, bonuses, and flexible PTO. Salary range: $95,000 - $175,700, based on experience and qualifications.

Get to know Syneos Health

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

Join us to challenge the status quo and make a difference. Learn more at our website.

Additional Information

Tasks and responsibilities may evolve. We consider equivalent experience and skills and are committed to compliance with all applicable laws and regulations, including the ADA and EU directives.