Senior / Principal Medical Writer - Regulatory - Sponsor Dedicated - CMH Experience (Home-based[...]

Syneos Health / inVentiv Health Commercial LLC; Honolulu (HI); Remote; USD 95,000 - 176,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior/Principal Medical Writer to mentor junior writers and manage complex projects. The ideal candidate will develop regulatory documents and adhere to industry standards. This role offers a salary range of $95,000 - $175,700 based on skills and qualifications, along with comprehensive benefits including health, 401k matching, and bonuses.

Benefits

Health benefits

401k matching

Flexible PTO

Company car or allowance

Stock purchase plan

Bonuses

Qualifications

• Relevant experience in medical writing or a related field required.
• Understanding of FDA and ICH regulations preferred.
• Ability to manage project budgets effectively.

Responsibilities

• Mentor and lead less experienced medical writers.
• Develop and support various regulatory documents.
• Adhere to regulatory standards and provide peer review.

Skills

Strong knowledge of English grammar and AMA style

Effective presentation skills

Proofreading skills

Interpersonal skills

Familiarity with clinical research principles

Education

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

Tools

Word

Excel

PowerPoint

Job description

Senior / Principal Medical Writer - Regulatory - Sponsor Dedicated - CMH Experience (Home-based, US or Canada)

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

Whether joining 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 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 develop our people through career progression, supportive management, training, peer recognition, and rewards.
• Our Total Self culture encourages authenticity and caring for our people.
• We value diversity of thoughts, backgrounds, and perspectives to foster a sense of belonging.

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Represent the Medical Writing department on clinical study teams, at conferences, and client meetings.
• Advise clients and study teams on data presentation, production strategies, and data quality standards.
• Develop and support various documents, including 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, relevance, and quality standards.
• Adhere to regulatory standards, including ICH-E3 guidelines, SOPs, and client standards.
• Perform literature searches and maintain professional development.
• Manage project budgets and communicate changes.
• Complete administrative tasks timely; minimal travel may be required.

Qualifications

• Bachelor's degree in Science, Arts, or related field with relevant experience.
• 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, and Internet.
• Familiarity with clinical research principles and data interpretation.

We offer benefits such as a company car or allowance, health benefits, 401k matching, stock purchase plan, bonuses, and flexible PTO. Salary range: $95,000 - $175,700. Actual salary depends on qualifications and skills.

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

Tasks and responsibilities are not exhaustive; additional duties may be assigned. We are committed to compliance with applicable laws and providing accommodations under the ADA.