Principal Medical Writer (Regulatory)

MedStar Health; Maryland; On-site; USD 95,000 - 176,000; Full time

Job summary

A leading healthcare organization is seeking a Principal Medical Writer (Regulatory) to mentor teams, manage medical writing activities, and develop crucial clinical documents. This role requires strong communication skills, a bachelor's degree, and familiarity with FDA regulations. Competitive salary and benefits available.

Benefits

Health benefits

401k matching

Stock purchase plan

Bonuses

Flexible PTO

Qualifications

• Bachelor's degree is required.
• Familiarity with AMA style preferred.
• Understanding of FDA and ICH regulations is a plus.

Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Manage medical writing activities for individual studies.
• Develop documents like clinical protocols and submissions.

Skills

Excellent command of English grammar

Effective presentation skills

Proofreading skills

Interpersonal skills

Ability to interpret clinical data

Education

Bachelor's degree in Science, Arts, or related field

Tools

Word

Excel

PowerPoint

Job description

Principal Medical Writer (Regulatory)

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 puts the customer and the patient at the center of everything we do. We are continuously seeking ways to simplify and streamline our work to make Syneos Health easier to work with and 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 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 development, progression, supportive management, training, peer recognition, and rewards.
• We are committed to our Total Self culture, where you can be yourself. We take care of our people, fostering diversity and inclusion.

Job Responsibilities

1. Mentor and lead less experienced medical writers on complex projects.
2. Represent the Medical Writing department on clinical study teams, at conferences, and in client presentations.
3. Advise clients and study teams on data presentation, production strategies, and quality standards.
4. Develop strong working relationships internally and externally.
5. Manage medical writing activities for individual studies, coordinating across departments.
6. Develop or support documents such as clinical protocols, reports, narratives, development plans, submissions, and manuscripts.
7. Review statistical analysis plans and specifications for content, grammar, and consistency.
8. Provide peer review to ensure clarity, accuracy, relevance, and quality.
9. Adhere to regulatory standards, SOPs, templates, and deadlines.
10. Perform literature searches as applicable.
11. Engage in professional development to stay current with guidelines and improve skills.
12. Understand and work within budget constraints.
13. Complete administrative tasks timely.
14. Perform other duties as assigned, with minimal travel.

Qualifications

1. Bachelor's degree in Science, Arts, or related field with relevant experience.
2. Excellent command of English grammar, familiarity with AMA style.
3. Understanding of FDA and ICH regulations preferred.
4. Effective presentation, proofreading, and interpersonal skills.
5. Proficiency in Word, Excel, PowerPoint, email, and internet.
6. Ability to interpret clinical data and complex information.

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

Learn more about us at http://www.syneoshealth.com

Additional Information

Tasks and responsibilities are not exhaustive. The company may assign additional duties at its discretion. Qualifications may be considered equivalent, and nothing herein constitutes a contract. We are committed to compliance with applicable laws and providing reasonable accommodations.