Principal Medical Writer

Actalent • Raleigh, NC • 1d ago

Job Title: Principal Medical Writer I

Job Description

The Associate Director, Principal Medical Writer I is responsible for developing clinical documents for submissions to regulatory authorities globally. You will provide strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents, such as Investigators' Brochures, Clinical Study Reports, and marketing authorization submission documents, accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. In this role, you will write or provide direction and leadership to other writers, ensuring the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and feature accurate data presentation and interpretation. You will oversee the medical writing activities of multiple compounds and serve as the lead writer for individual summary documents. You will have a broad understanding of clinical research processes and global regulatory document standards and will mentor less experienced writers.

Responsibilities

Develop clinical documents for global regulatory submissions.

Provide strategic direction to cross-functional project teams.

Ensure clinical documents accurately present key data-driven messages.

Write and direct the creation of high-quality scientific documents.

Oversee medical writing activities for multiple compounds.

Serve as lead writer for individual summary documents.

Mentor less experienced writers.

Essential Skills

Technical writing and medical writing expertise.

Bachelor's degree required; advanced degree preferred.

At least 7 years of medical writing experience in the biopharmaceutical/CRO industry.

Experience leading submissions for marketing approval.

Proficiency in organizing and communicating clinical information.

Strong organizational, time management, and project management skills.

Strong verbal, written, and interpersonal communication skills.

Additional Skills & Qualifications

Experience with MS Word and StartingPoint templates.

Knowledge of FDA and EMA regulatory requirements.

Experience with all phases of clinical trials, I-IV.

Experience in both CRO and sponsor environments.

Focus on oncology and immunology therapeutic areas.

Work Environment

This role is 100% remote, offering the flexibility to work from anywhere in the EST time zone for US-based individuals. The position is fully allocated at 40 hours a week, with a laptop provided. You will be working primarily on writing summary documents and Clinical Study Reports, as well as overseeing document writing outsourced to third parties.

Pay and Benefits

The pay range for this position is $90.00 - $90.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on May 27, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Similar Jobs

Medical Scribe

CVS Health • Raleigh, NC • 4h ago

Hospital & Medical

At CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions compan...

4h ago

Go to Apply

Registered Nurse, RN

BAYADA Home Health Care • Raleigh, NC • 1d ago

Hospital & Medical

Come for the Flexibility, Stay for the Culture ( https://www.bayada.com/the-bayada-way.asp ) Needing more 'life' in your work-life balance? Apply to our talent network today! Now offering up to $10,000 sign-on bonus for...

1d ago

Go to Apply

Registered Nurse

Health Advocates Network • Raleigh, NC • 2d ago

Hospital & Medical

Health Advocates Network is currently seeking a Registered Nurse to work at a Facility in Raleigh, North Carolina . These are registry positions with our company. Pay Rate: $55 / hour *W2 Shift Details: Mental Health 054...

2d ago

Go to Apply

Licensed Practical Nurse

Health Advocates Network • Raleigh, NC • 2d ago

Hospital & Medical

Health Advocates Network is currently seeking a Licensed Practical Nurse to work at a Facility in Raleigh, North Carolina . These are registry positions with our company. Pay Rate: $40 / hour *W2 Shifts Available: Region...

2d ago

Go to Apply

Utilization Management Nurse Consultant

CVS Health • Raleigh, NC • 3d ago

Hospital & Medical

3d ago

Go to Apply

Utilization Management Nurse Consultant

CVS Health • Raleigh, NC • 3d ago

Hospital & Medical

3d ago

Go to Apply

Associate Chief Medical Officer, Quality and Safety

UNC Health Care • Raleigh, NC • 4d ago

Hospital & Medical

Description Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary : The Associate Chief Medical Officer, Qu...

4d ago

Go to Apply

Medical Office Assistant Administrative - UNC Primary Care at Clayton

UNC Health Care • Clayton, NC • 4d ago

Hospital & Medical

4d ago

Go to Apply

Registered Nurse

PruittHealth • Raleigh, NC • 5d ago

Hospital & Medical

REGISTERED NURSE Full Time 12 hr shifts 7a- 7p & 7p-7a, ask about Part Time Join the PruittHealth family, where the health and safety of our workforce is our top priority! We're not only committed to your career, we'...

5d ago

Go to Apply

Medical Account Manager

Mitsubishi Chemical Group • Raleigh, NC • 5d ago

Hospital & Medical

Medical Account Manager (2063) Title:Medical Account Manager Group Company: Mitsubishi Chemical Advanced Materials Location:Remote Employment Type:Full time Group Company: Mitsubishi Chemical Advanced Materials Mitsubish...

5d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.