Medical Writer

JOB 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.
KEY 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 guidelines
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
QUALIFICATIONS:
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
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 with 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