Medical Writer

Overview:
We are seeking a Medical Writer to join our dynamic team. This role will report into the Principal Medical Writer.

**Responsibilities**:
**Regulatory Medical Writing (Clinical Trial Documents)**:

- Write and edit clinical study protocols, informed consent forms, investigator brochures, clinical study reports, and other clinical trial-related documents.
- Conduct literature reviews and research to support the development of clinical trial documents.
- Ensure compliance with regulatory guidelines, internal processes, and industry standards.

**Non-Regulatory Medical Writing (Medical Communication and Scientific Exchange)**:

- Write and edit clinical reports based on real-world data, research papers, review articles, case reports, posters and presentations for conferences, and slide decks.

**Cross-Functional Collaboration**:

- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, data management, and quality assurance to obtain necessary information and input for document preparation.
- Participate in team meetings, contribute to discussions, and provide scientific insights to support decision-making processes.
- Engage in scientific review processes, such as peer review, internal review, or expert review, to ensure accuracy, clarity, and scientific integrity of the written content.

**Document Management and Quality Control**:

- Maintain documentation standards and templates for clinical and non-clinical documents.
- Ensure adherence to regulatory requirements and internal processes related to document preparation, review, and approval.
- Implement and maintain document version control.

Qualifications:
**Major and Degree**
- Bachelor’s or Master’s degree in a life sciences discipline (e.g. pharmacology, biology, biochemistry, physiology, genetics, etc.).

**Working Experience**
- Minimum of 5 years of experience working as a Medical Writer in either the pharmaceutical industry or a Contract Research Organization (CRO).
- Proven experience in writing both regulatory and non-regulatory documents.
- Comprehensive knowledge of ICH-CGP (certified preferred).

**Capability and Skills**
- Strong knowledge of regulatory guidelines (e.g., ICH, FDA, EMA) and industry standards related to the preparation of regulatory documents.
- Familiarity with drug development processes, clinical trial design, and statistical concepts.
- Excellent scientific writing skills, with the ability to effectively communicate complex information to diverse audiences.
- Proficiency in using MS Office Suite (Word, Excel, PowerPoint).
- Detail-oriented, with exceptional organizational and time management skills.
- Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
- Strong analytical and problem-solving skills.
- Knowledge of medical terminology and scientific literature search techniques.
- GCP certification is a plus.
- Real-world evidence (RWE) research experience is a plus.