FULLY REMOTE
Must have experience:
4 year degree
Need to be able to author independently (2+ years authoring)
Experience with CSPs, CSRs, IBs, ICFs, supporting regulatory documents
Must have Veeva RIM experience
CNS experience
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, Clinical Study Reports, Investigator's Brochures, Informed Consent Forms, Common Technical Document Modules, Briefing Documents for Regulatory Authorities, Periodic Safety Update Reports, Pediatric Investigation Plans, New Drug Applications, Biologics License Applications, Marketing Authorization Applications, and responses to regulatory queries.
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 experience in writing regulatory documents for clinical trials.
Experience with drug development across different phases (Phase I-IV).
Strong understanding of the drug development process, clinical research concepts, clinical study conduct, clinical study data collection, regulatory requirements, and biostatistical concepts.
Familiarity with medical terminology and ability to interpret complex clinical data.
Strong understanding of the concepts of coding dictionaries (MedDRA, WHODrug, etc.).
Excellent scientific writing, editing, and document structuring skills.
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.
Experience with CSPs, CSRs, IBs, ICFs, and supporting regulatory documents.
Should be able to be lead author independently with 2-3 years of experience.
Global Phase 3 studies and pivotal studies experience.
CNS experience.
Epilepsy experience is highly preferred.
Clear communication skills necessary.
Someone that may be able to come into the office once a quarter would be ideal.
EST working time zone required, living in EST preferred.
Work Environment
This position is fully remote, with a preference for candidates who can come onsite once per quarter if local. The industry-specific experience with editing and updating clinical documents is required. The role involves working with cross-functional teams, and it is essential for candidates to have clear communication skills and the ability to collaborate effectively. The work environment is fast-paced, requiring the ability to manage multiple projects and meet deadlines.
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 Mar 6, 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
