Actalent is hiring: Medical Writer in Paramus

Job Title: Medical Writer
Job Description
We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory guidelines. The ideal candidate will collaborate with cross-functional teams, including Clinical, Regulatory, Biostatistics, and Medical Affairs, to create well-structured, scientifically accurate, and regulatory-compliant documents.
Responsibilities

Prepare and author clinical and regulatory documents, including Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Common Technical Document (CTD) Modules, Briefing Documents for Regulatory Authorities, Periodic Safety Update Reports (PSURs), and Pediatric Investigation Plans (PIPs).
Develop and maintain clinical development plans, clinical trial protocols, and statistical analysis plans.
Collaborate with clinical teams to ensure alignment of clinical documents with study objectives and regulatory requirements.
Interpret complex scientific and clinical data and communicate findings clearly and concisely.
Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable regulatory agency guidelines.
Maintain up-to-date knowledge of regulatory writing best practices, industry trends, and evolving guidelines.
Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams.
Review and edit documents prepared by internal teams or external vendors to ensure scientific accuracy, clarity, and compliance.
Participate in team meetings, regulatory interactions, and strategy discussions.
Drive document production timelines according to established plans.
Plan and manage multiple simultaneous document development projects with shifting priorities.
Essential Skills

Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field.
Minimum 3-5 years of medical writing experience in the pharmaceutical, biotech, or CRO industry.
Strong background in writing regulatory documents for clinical trials and submissions.
Ability to simplify complex scientific concepts for diverse audiences.
Proficiency in ICH guidelines, GCP, and regulatory submission requirements (FDA, EMA, etc.).
Strong attention to detail, ability to manage multiple projects, and meet deadlines.
Ability to work independently and collaboratively in a fast-paced environment.
High level of proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Experience with document management systems and publishing tools (e.g., EndNote, Adobe Acrobat, regulatory submission platforms).
Veeva experience.
Additional Skills & Qualifications

5 years of medical writing experience.
Experience supporting phase 3 studies, including CSPs, CSRs, IBs, and ICFs.
Ability to be lead author independently with 2-3 years of experience authoring.
Experience with global phase 3 studies and pivotal studies.
CNS experience, with epilepsy experience highly preferred.
Clear communication skills necessary.
Ability to work in the EST time zone, with preference for living in EST.
Work Environment
The position is fully remote, with the preference for someone who can come on site once per quarter if local. The role involves working with cross-functional teams in a fast-paced environment. The work culture values clear communication and the ability to collaborate effectively. The ideal candidate will have experience with industry-specific editing and updating clinical documents.
Job Type & Location
This is a Contract position based out of Paramus, NJ.
Pay and Benefits
The pay range for this position is $70.00 - $80.00/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 22, 2026.
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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.