Job Summary

HR Service Jobs is seeking a highly skilled Senior Medical Writer to join our dynamic team. In this role, you will be responsible for producing high-quality medical and scientific documentation that adheres to regulatory guidelines and industry standards. Your expertise will support various stakeholders, including pharmaceutical companies, biotech firms, and healthcare organizations. This position offers flexibility with options for full-time, part-time, or freelance engagements.

Key Responsibilities

• Develop, write, and edit a variety of clinical documents, including clinical study protocols, investigator brochures, clinical study reports, and regulatory submission documents.
• Collaborate with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to gather and interpret data for accurate reporting.
• Ensure all documents are scientifically accurate, compliant with regulatory requirements, and tailored to the target audience.
• Conduct thorough literature reviews to support document content and enhance the quality of submissions.
• Review and provide feedback on documents authored by other team members to maintain consistency and quality standards.
• Stay current with industry trends, guidelines, and best practices in medical writing and regulatory submissions.

Required Skills and Qualifications

• Masters degree or higher in a life sciences field (PhD preferred) or equivalent experience.
• Proven experience in medical writing within the pharmaceutical or biotech industry, with a focus on regulatory documentation.
• Strong understanding of clinical trial processes and regulatory requirements (e.g., ICH, FDA).
• Excellent written and verbal communication skills, with a keen eye for detail.
• Proficiency in scientific terminology and the ability to convey complex information clearly and concisely.

Experience

• Minimum of 5 years of experience in medical writing or a related field.
• Demonstrated success in authoring clinical documents that meet regulatory standards.
• Experience working in a fast-paced environment and managing multiple projects simultaneously.

Working Hours

• Flexible working hours available, with options for full-time, part-time, or freelance arrangements. Specific hours can be discussed during the interview process.

Knowledge, Skills, and Abilities

• Strong analytical skills and the ability to interpret complex data.
• Ability to work collaboratively in a team environment while also being self-motivated and capable of working independently.
• Proficiency with Microsoft Office Suite and familiarity with electronic document management systems.
• Knowledge of statistical analysis and familiarity with software such as SAS or R is a plus.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive health benefits, including medical, dental, and vision coverage.
• Flexible work arrangements to promote work-life balance.
• Opportunities for professional development and continuous learning.
• Generous paid time off and holiday policies.

Why Join Us

At HR Service Jobs, we value innovation, integrity, and collaboration. Joining our team means becoming part of a diverse and inclusive workplace where your expertise will make a significant impact on healthcare advancements. You will have the opportunity to work on exciting projects with leading organizations in the medical field, all while enjoying the flexibility to balance your professional and personal life.

How to Apply

If you are a dedicated and experienced Senior Medical Writer looking to make a difference in the medical field, we would love to hear from you! Please submit your resume, cover letter, and any relevant writing samples to us. We look forward to reviewing your application and potentially welcoming you to our team!