Job Description

Job Title	Medical Writer
Reports to	CEO
Department	Clinical Trials
Location	Remote
Job Type	Contract
Supervises	None

Company Overview

Credevo is a global consulting organization supporting healthcare product development from clinical development to commercialization. Credevo provides strategic support in areas such as regulatory, clinical development, licensing (out-/in-), and feasibility support, for products including pharmaceuticals, biologics, nutraceuticals, and medical devices.

Position Overview

We are looking for a skilled Medical Writer to create accurate, engaging, and
regulatory-compliant medical content. The ideal candidate will be responsible for writing
scientific documents, clinical study reports, regulatory submissions, and other medical
communications for clinical trials and pharmaceutical companies.

Essential duties and responsibilities (including, but not limited to the following):

● Develop and write high-quality clinical study reports (CSRs), protocols, SOPs,
Articles, Blogs, investigator brochures (IBs), regulatory submissions, and
scientific publications.
● Prepare manuscripts, white papers, literature reviews, and abstracts for journals
and conferences.
● Collaborate with cross-functional teams, including clinical research, regulatory affairs,
and biostatistics.
● Ensure compliance with ICH-GCP, regulatory guidelines (FDA, EMA, ICMR), and
industry standards.
● Conduct extensive literature reviews and summarize scientific data effectively.
● Edit and proofread medical content to ensure clarity, accuracy, and consistency.
● Support the development of medical and scientific training materials.
● Stay updated with latest industry trends, drug development processes, and clinical
research advancements.

Qualifications & Skills:

● Bachelor’s in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related field.
● 3 – 5 years of experience in medical writing, clinical research, or pharmaceutical
regulatory documentation.
● Strong understanding of clinical trials, medical terminology, and regulatory
requirements.
● Excellent written and verbal communication skills.
● Proficiency in MS Office (Word, Excel, PowerPoint) and reference management
tools.
● Ability to interpret and analyze scientific data and present it effectively.
● Can write SEO friendly articles & blogs
● Detail-oriented, highly organized, and capable of working independently and in teams.

Job Requirements

1. Education: At least a Masters’s degree in medicine, pharmacy, or a scientific- or healthcare-related field.
2. Prior Work Experience: At least 5 years of experience in clinical trials, preferably focusing on clinical trial strategy, plan, and design.
3. Job Knowledge:
   • Strong understanding of Good Clinical Practice (GCP) guidelines, industry standards, and regulatory requirements, particularly in regions of Southeast Asia, East Asia, Japan, and Australia
   • Strong understanding of drug development process and clinical trial methodology & operations.
   • Excellent attention to detail and the ability to prioritize and multitask in a fast-paced environment.
   • Strong written and verbal communication skills, with the ability to effectively collaborate with internal and external stakeholders.
   • Demonstrable problem-solving skills and ability to exercise independent judgment.
   • Proficiency in using clinical trial management systems and electronic data capture (EDC) systems.
   • Advanced level expertise in using Excel and Word.
   • On-hands past experience of conducting studies in South East Asia, East Asia, Japan, and Australia (desirable).
   • Certification in clinical research/project management (such as ACRP or SoCRA or PMP) (desirable).

Preferred Qualifications:

● Familiarity with publication guidelines (ICMJE, GPP3).
● Prior experience with regulatory writing (IND, NDA, CSR, CTD modules, etc.).

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