Medical Writer

Description SUMMARY OF POSITION 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. JOB REQUIREMENTS u2022 Regulatory Document Writing: o Prepare and author clinical and regulatory documents, including but not limited to: uf0a7 Clinical Study Protocols (CSPs) and Protocol Amendments uf0a7 Clinical Study Reports (CSRs) uf0a7 Investigatoru2019s Brochures (IBs) uf0a7 Informed Consent Forms (ICFs) uf0a7 Common Technical Document (CTD) Modules (e.g., Module 2.5 Clinical Overview, Module 2.7 Clinical Summary) uf0a7 Briefing Documents for Regulatory Authorities (e.g., FDA, EMA) uf0a7 Periodic Safety Reports uf0a7 Risk Management Plans (RMPs) and Pediatric Investigation Plans (PIPs) uf0a7 New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs) uf0a7 Responses to regulatory queries u2022 Clinical Development Support: o Develop and maintain clinical development plans, clinical trial protocols, and statistical analysis plans o Collaborate with clinical teams to ensure alignment of clinical documents with study objectives and regulatory requirements o Interpret complex scientific and clinical data and communicate findings clearly and concisely u2022 Regulatory Compliance & Standards: o Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable regulatory agency guidelines o Maintain up-to-date knowledge of regulatory writing best practices, industry trends, and evolving guidelines u2022 Collaboration & Review: o Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams o Review and edit documents prepared by internal teams or external vendors to ensure scientific accuracy, clarity, and compliance o Participate in team meetings, regulatory interactions, and strategy discussions o Drive document production timelines according to established plans o Plan and manage multiple simultaneous document development projects with shifting priorities EDUCATION PREFERRED u2022 Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field WORK EXPERIENCE u2022 Minimum 3-5 years of medical writing experience in the pharmaceutical, biotech, or CRO industry u2022 Strong background in writing regulatory documents for clinical trials and submissions u2022 Epilepsy or Neurology experience is a plus u2022 Experience with drug development across different phases (Phase I-IV) is a plus u2022 Strong understanding of the drug development process, clinical research concepts, clinical study conduct, clinical study data collection, regulatory requirements, and biostatistical concepts u2022 Familiarity with medical terminology and ability to interpret complex clinical data u2022 Strong understanding of the concepts of coding dictionaries (MedDRA, WHODrug, etc.) u2022 Excellent scientific writing, editing, and document structuring skills u2022 Ability to simplify complex scientific concepts for diverse audiences u2022 Proficiency in ICH guidelines, GCP, and regulatory submission requirements (FDA, EMA, etc.) u2022 Strong attention to detail, ability to manage multiple projects, and meet deadlines u2022 Ability to work independently and collaboratively in a fast-paced environment u2022 High level of Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) u2022 Experience with document management systems and publishing tools (e.g., EndNote, Adobe Acrobat, regulatory submission platforms) u2022 Veeva experience Skills Audit, Gcp, cro audit, tmf, edc Top Skills Details Audit,Gcp,cro audit,tmf,edc Additional Skills & Qualifications NEW UPDATED REQ INFO SK Life Science is looking to fill one additional Medical Writer position. The job description has been reattached here for your references, as well. Please do not submit candidates into SWM VMS unless they meet all requirements below: 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 Must Haves: 5 years of Medical writing experience Most urgent need is supporting phase 3 study CSPs, CSRs, IBs, ICFs, supporting regulatory documents Should be able to be lead author independently (2-3 years experience authoring) Global phase 3 studies, pivotal studies Technology: Veeva RIM, Microsoft suite, 4 year degree CNS experience Like to Haves: epilepsy experience 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 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 Apr 20, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-04-08