Medical Writer Job at Staffingagencyrecruitment in Paramus

Experience level: Mid-senior

Experience required: 5 Years

Education level: Doctorate

Job function: Health Care Provider

Industry: Pharmaceuticals

Total position: 1

Relocation assistance: No

Visa sponsorship eligibility: No

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 effective verbal communication.

Adapt and adjust to change and grasp 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.

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