Temporary Assignment Duration: 5 Months Work Type: Remote Shift: Mon-Fri 9.00 AM-5.00 PM * We are ... Strong understanding of the concepts of coding dictionaries (MedDRA, WHODrug, etc.) * Excellent ...
Temporary Assignment Duration: 5 Months Work Type: Remote Shift: Mon-Fri 9.00 AM-5.00 PM * We are ... Strong understanding of the concepts of coding dictionaries (MedDRA, WHODrug, etc.) * Excellent ...
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Job description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
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
Job Description:
DUTIES AND RESPONSIBILITIES
Regulatory Document Writing:
Clinical Development Support:
Collaboration & Review:
EDUCATION PREFERRED :
WORK EXPERIENCE:
PHYSICAL AND MENTAL REQUIREMENTS
OTHER:
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
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
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.
About Merican
Sourced by ZipRecruiter
Merican is a IT Service consulting firm, specialized in Digital adoption and Business automation. With our diverse collection of skilled and committed consultants, technology companies, businesses and digital experts, we provide our subject expertise and our unique client service approach, a best-in-class global model of delivery suited to the business demands of our clients. We ensure that we implement future-oriented solutions for our clients via investments in people, solutions, technologies, competencies and infrastructure.
Industry
It services
Company size
51 - 200 Employees
Headquarters location
Columbia , MD, US
Year founded
2020