**Job Post: Expert Technical Writer (Medical & Scientific Communications)**  

**Company:** Maliza Consults  

**Location:** Remote  

**Job Type:**Contract  

### **About Us**  

Maliza Consults is a premier medical and scientific communications firm specializing in translating complex research into clear, compliant, and compelling content. We support pharmaceutical companies, biotech innovators, CROs, and healthcare organizations in developing high-impact regulatory documents, publications, and educational materials.  

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### **Role Overview**  

We seek an **Expert Technical Writer** with deep experience in medical/scientific documentation to lead the development of advanced technical and regulatory content. You will be responsible for creating, editing, and standardizing high-stakes documents that meet global compliance standards while ensuring scientific precision and clarity.  

### **Key Responsibilities**  

- Author and refine **regulatory, clinical, and technical documents**, including:  

 - **Clinical study protocols, CSRs, IBs, and SAPs**  

 - **Regulatory submissions** (INDs, NDAs, BLAs, CTDs)  

 - **Medical device documentation** (IFUs, technical reports)  

 - **Peer-reviewed manuscripts, conference abstracts, and posters**  

- Ensure adherence to **ICH-GCP, FDA, EMA, and ISO** guidelines.  

- Collaborate with **cross-functional teams** (R&D, regulatory affairs, biostatistics) to align content with project goals.  

- Develop and maintain **templates, style guides, and SOPs** for consistency.  

- Lead **quality control reviews** for accuracy, compliance, and readability.  

- Mentor junior writers and contribute to process improvements.  

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### **Qualifications**  

#### **Required**  

- **Advanced degree** (PhD, MD, PharmD, or MSc in Life Sciences/Medicine).  

- **5+ years in technical/regulatory medical writing** (pharma, biotech, or CRO).  

- Mastery of **regulatory requirements** (e.g., eCTD structure, 21 CFR Part 11).  

- Exceptional ability to **interpret clinical data and statistical outputs**.  

- Proficiency with **document management systems** (Veeva, DocuSign, SharePoint).  

#### **Preferred**  

- Certification (**AMWA, EMWA, RAC**).  

- Experience with **risk management documents** (DSURs, PSURs).  

- Knowledge of **AI/ML applications in medical writing**.  

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### **Why Join Us?**  

- **Impactful work**: Shape critical documents that advance patient care.  

- **Flexibility**: Remote-first culture with optional hybrid roles.  

- **Growth**: Leadership opportunities and continuous learning.  

- **Competitive compensation**: Attractive salary/contract rates + bonuses.  

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### **Application Process**  

Submit the following to **[careers@malizaconsults.com]** with subject line **"Expert Technical Writer Application – [Your Name]"**:  

1. **Resume/CV**  

2. **Cover letter** highlighting regulatory writing experience  

3. **2–3 writing samples** (e.g., CSR excerpt, protocol section, published manuscript)  

*Maliza Consults is an equal-opportunity employer. We celebrate diversity and are committed to an inclusive workplace.*  

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