Paramus
Job Title: Medical Writer Location: Paramus, NJ, 07652 Job Type: Temporary Assignment Duration: 5 Months Work Type: Remote Shift: Mon-Fri 9.00 AM-5.00 PM Pay rate: $70.00 - $80.00/hr. Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. 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. DUTIES AND RESPONSIBILITIES Regulatory Document Writing: • Prepare and author clinical and regulatory documents, including but not limited to:, • Clinical Study Protocols (CSPs) and Protocol Amendments, • Clinical Study Reports (CSRs), • Investigator’s Brochures (IBs), • Informed Consent Forms (ICFs), • Common Technical Document (CTD) Modules (e.g., Module 2.5 Clinical Overview, Module 2.7 Clinical Summary), • Briefing Documents for Regulatory Authorities (e.g., FDA, EMA), • Periodic Safety Reports, • Risk Management Plans (RMPs) and Pediatric Investigation Plans (PIPs), • New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs), • Responses to regulatory queries Clinical Development Support: • 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, • Regulatory Compliance & Standards:, • 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 guideline Collaboration & Review: • 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 EDUCATION PREFERRED : • Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, Pharmacy, or a related field WORK EXPERIENCE: • 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, • Epilepsy or Neurology experience is a plus, • Experience with drug development across different phases (Phase I-IV) is a plus, • 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 PHYSICAL AND MENTAL REQUIREMENTS • Ability to multitask, • Maintain composure under pressure, • Ability to follow verbal or written instructions and use of effective verbal communications, • Adapts and adjusts to change and grasps information quickly, • Detail-oriented OTHER: • Must have excellent, concise, and clear written and oral communication skills; possess strong analytical and interpersonal skills, ability to work independently., • Highly motivated self-starter witha a positive attitude, possessing the initiative required to achieve desired goals both independently and within a team structure., • Demonstrated project management ability., • Excellent interpersonal, oral and written communication skills., • Strong relationship-building skills., • Team-oriented, with the ability to work effectively with others TekWissen® Group is an equal opportunity employer supporting workforce diversity.