Job Description

Medical Writer

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 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

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 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

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

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