Principal Medical Writer (Regulatory)

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

Job summary

A leading health organization is seeking a Principal Medical Writer (Regulatory) to mentor junior writers and manage medical writing activities. The role involves preparing critical documents and ensuring compliance with regulatory standards. Candidates should have a Bachelor’s degree and strong writing and presentation skills.

Benefits

Health coverage

401k

Stock purchase plans

Bonuses

Flexible PTO

Qualifications

• Bachelor's degree in Science, Arts, or related fields with relevant experience.
• Familiarity with FDA and ICH regulations preferred.
• Proficiency in Word, Excel, PowerPoint, email, and internet.

Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Develop and manage medical writing activities for individual studies.
• Prepare various documents, including clinical protocols and reports.

Skills

Excellent English grammar

Effective presentation skills

Proofreading skills

Interpersonal skills

Education

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

Tools

Word

Excel

PowerPoint

Job description

Principal Medical Writer (Regulatory)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

Our Clinical Development model centers on the customer and the patient. We continuously seek ways to simplify and streamline our work to make Syneos Health both easier to work with and easier to work for.

Whether partnering in a Functional Service Provider model or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our clients 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 growth, supportive management, training, peer recognition, and rewards.
• We foster a Total Self culture where you can be authentic. We are committed to taking care of our people and creating a diverse, inclusive environment.

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Represent the Medical Writing department on clinical study teams, conferences, meetings, and client presentations.
• Advise clients and study teams on data presentation, production strategies, and quality standards.
• Develop and manage medical writing activities for individual studies, coordinating across departments.
• Prepare various documents, including clinical protocols, reports, narratives, development plans, submissions, and manuscripts.
• Review statistical analysis plans and specifications for content, grammar, and consistency.
• Serve as peer reviewer to ensure clarity, accuracy, relevance, and quality.
• Adhere to regulatory standards, SOPs, templates, and timelines.
• Perform literature searches and maintain professional development.
• Understand and work within budget constraints, communicating any changes.
• Complete administrative tasks timely; minimal travel may be required.

Qualifications

• Bachelor's degree in Science, Arts, or related fields with relevant experience or knowledge.
• Excellent English grammar, familiar with AMA style guide.
• Understanding of FDA and ICH regulations preferred.
• Effective presentation, proofreading, and interpersonal skills.
• Proficiency in Word, Excel, PowerPoint, email, and internet.
• Familiarity with clinical research principles and data interpretation.

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

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

Additional Information

Tasks and responsibilities are not exhaustive. We may assign additional duties at our discretion. Qualifications may be considered equivalent where appropriate. This description does not constitute a contract. We are committed to compliance with applicable laws and providing accommodations under the ADA.