Our biotech company in San Francisco is on the hunt for a meticulous and innovative Medical Writer to join our growing team. We need a highly skilled communicator who can transform complex scientific data into easily digestible content for a variety of audiences, ranging from regulatory bodies and healthcare professionals to patients and the general public. This role is essential for our company's mission to improve patient outcomes through cutting-edge therapies. This is a full-time, on-site position with opportunities for remote work.
Key Responsibilities:
- Regulatory Writing Expertise: Develop and maintain clinical study reports (CSRs), investigator brochures (IBs), and other regulatory documents. Ensure all materials are compliant with FDA and international guidelines.
- Publication Planning and Execution: Participate in the planning and execution of scientific publications, including peer-reviewed articles, abstracts, and poster presentations. Collaborate with researchers and medical affairs professionals to generate high-quality publications.
- Medical Communications Content Creation: Create a range of medical communication materials, such as slide decks, training modules, and educational resources for healthcare providers. Tailor content to meet the specific needs of different audiences.
- Literature Reviews and Data Synthesis: Conduct thorough literature reviews and synthesize complex data from clinical trials and other sources. Translate data into clear, concise, and accurate written materials.
- Collaboration and Teamwork: Work closely with cross-functional teams, including clinical development, medical affairs, and marketing. Contribute to the development of overall medical communication strategies.
- Maintain Current Knowledge: Stay up-to-date with current medical literature, regulatory guidelines, and industry trends. Apply this knowledge to the development of innovative and effective medical writing solutions.
- Quality Control: Ensure accuracy and consistency of all written materials through rigorous review and editing processes.
Essential Qualifications:
- A relevant scientific background, ideally in biology, pharmacology, or a related field.
- Proven capability in crafting regulatory documents, such as clinical study reports, investigator brochures, and safety updates.
- In-depth grasp of clinical trial designs, statistical analyses, and medical terminology.
- Fluency in regulations concerning medical writing and publishing ethics (ICH guidelines, GPP, etc.).
- Impeccable written and oral communication competencies.
- A commitment to excellence, accuracy, and scrupulousness in all aspects of medical writing.
What We Offer:
- A competitive salary with performance-based bonuses.
- Complete health, dental, and vision coverage.
- Generous paid time off (PTO) and company holidays.
- A 401(k) plan with employer matching.
- Proficient growth potential within the company.
- Engaging in projects and initiatives with real-world impact.
- A positive, diverse, and inclusive work environment. We embrace new ideas and strive for continuous growth.
If you possess a passion for medical communication and aspire to make a tangible difference in healthcare, we encourage you to apply. Your skill and dedication will play a crucial role in our mission to drive forward advancements in medicine.