About the role
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job Description
The Associate Medical Writer will work under the guidance and mentorship of experienced Medical Writers to support the timely delivery of high-quality clinical and regulatory documents. Responsibilities include contributing to the preparation of study protocols, clinical study reports (CSRs), investigator brochures (IBs), ICH M25/M27 documents, and other clinical, scientific, and regulatory documentation.
Key responsibilities include:
- Support the development, editing, formatting, and quality review of clinical, scientific, and regulatory documents in accordance with client requirements, internal standards, and applicable regulatory guidelines.
- Participate in project-related teleconferences and meetings, and coordinate meeting logistics as required.
- Prepare and distribute meeting minutes, action items, and follow-up communications.
- Assist in drafting and revising medical, scientific, regulatory, and procedural documents, including standard operating procedures (SOPs).
- Perform quality checks (QC) on documents prepared by Medical Writers and Senior Medical Writers to ensure accuracy, consistency, and compliance with established standards.
- Collaborate effectively with cross-functional teams to support project delivery timelines and quality objectives.
- Maintain document quality, version control, and project records in accordance with company procedures.
Job Requirements
Education
- Master's degree in Pharmacy, Medicine, Life Sciences, or a related scientific discipline.
- Advanced degrees such as an MD, PharmD, or PhD are preferred.
Qualifications and Skills
- Excellent written and verbal communication skills in English.
- Strong attention to detail and commitment to delivering high-quality work.
- Excellent organizational, planning, and time-management skills.
- Proficiency in Microsoft Office applications, including Word, PowerPoint, Excel, and SharePoint.
- Strong analytical, problem-solving, and critical-thinking skills.
- Ability to manage multiple tasks and priorities in a fast-paced environment.
- Ability to work independently as well as collaboratively within a team environment.
Experience
- Prior experience in a pharmaceutical company, CRO, or related healthcare industry is preferred but not required.
- Entry-level candidates with strong scientific writing skills and relevant academic training are encouraged to apply.
Aplyr's read
Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
What's promising
- •Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
- •The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
- •Global presence provides diverse career opportunities across multiple regions and disciplines.
What to watch
- •High pressure and fast-paced environment may not suit everyone.
- •Complex organizational structure can lead to communication challenges.
- •Frequent acquisitions may result in uncertainty and change for employees.
Why Thermo Fisher
- •Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
- •The company plays a crucial role in global scientific advancements and healthcare solutions.
- •Strong focus on sustainability and corporate responsibility sets it apart in the industry.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Thermo Fisher
Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.
