Job Description
The Associate Director, Principal Medical Writer II 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.
ResponsibilitiesDevelop 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 SkillsTechnical 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 & QualificationsExperience 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 21, 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 for other accommodation options.