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. #J-18808-Ljbffr