Medical Writer Job at Actalent in Paramus

Responsibilities

• Prepare and author clinical and regulatory documents (e.g., Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Informed Consent Forms, CTD modules, briefing documents, periodic safety reports, risk management plans, NDA/BLAs, responses to regulatory queries).
• Develop and maintain clinical development plans, protocols, and statistical analysis plans.
• Collaborate with cross‑functional teams (clinical, regulatory, biostatistics, medical affairs, QA) to ensure alignment with study objectives and regulatory requirements.
• Interpret and communicate complex scientific and clinical data clearly and concisely.
• Ensure all documents comply with ICH, GCP, FDA, EMA, and other applicable guidelines.
• Review and edit documents prepared by internal teams or external vendors for scientific accuracy, clarity, and compliance.
• Participate in meetings, regulatory interactions, and strategy discussions.
• Drive document production timelines and manage multiple simultaneous projects with shifting priorities.

Qualifications

• Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or related field.
• Minimum 3–5 years of medical writing experience in pharmaceutical, biotech, or CRO industry.
• Strong background in writing regulatory documents for clinical trials and submissions.
• Experience with drug development across phases I–IV; epilepsy or neurology expertise a plus.
• In-depth knowledge of clinical research concepts, study conduct, data collection, regulatory requirements, and biostatistical concepts.
• Familiarity with medical terminology, MedDRA, WHODrug coding dictionaries.
• Excellent scientific writing, editing, and document structuring skills; ability to simplify complex concepts for diverse audiences.
• Proficiency in ICH guidelines, GCP, and regulatory submission requirements (FDA, EMA).
• Strong attention to detail, project management skills, ability to meet deadlines.
• Ability to work independently and collaboratively in a fast‑paced environment.
• High proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Experience with document management systems and publishing tools (EndNote, Adobe Acrobat, regulatory submission platforms).
• Veeva experience.

Must‑Haves

• 5 years of medical writing experience, including 2–3 years as lead author.
• Experience supporting phase 3 pivotal studies.
• Experience with global phase 3 studies.
• Veeva RIM usage; Microsoft suite.
• Strong CNS (central nervous system) experience.
• Will work in EST time zone; living in EST preferred; available to travel to office once per quarter.

Preferred Qualifications

• Experience with epilepsy studies.
• Clear communication skills.

Job Type & Location

• Contract position based out of Paramus, NJ; fully remote.

Pay & Benefits

• Hourly rate: $70–$80 per hour.
• Benefits: medical, dental & vision; critical illness, accident, and hospital; 401(k) retirement plan; life insurance; disability; health spending account; transportation; employee assistance; PTO/leave.

Legal Notice

Actalent is an equal opportunity employer.