Current Job Openings
AD/Manager, Regulatory Medical Writing - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for an AD/Manager, Regulatory Medical Writing with a biotech company in San Diego, CA who possesses:
- PhD or PharmD highly preferred, Master's or B.S. considered with sufficient industry experience
- 3+ years of medical writing experience
- Strong written and verbal communication skills
- Ability to critically analyze medical documents, procedures, scientific data
- Management, supervisory, or leadership experience required
Email resumes to aaron@simplybiotech.com or call 858.427.3668
FULL DESCRIPTION: The Manager of Regulatory Medical Writing is responsible for managing and directing the regulatory writing team to produce high-quality documents for regulatory submissions. This role includes the planning, writing, and reviewing of regulatory documents, ensuring compliance with regulatory and other submission requirements, and providing strategic direction to support drug development and regulatory approval processes. This role may involve a combination of remote and office-based work. Some travel may be required for meetings, conferences, or training sessions.
The selected candidate will be responsible for:
- Team Management: Lead, mentor, and manage a team of medical writers, providing guidance and support to ensure high performance and professional growth.
- Project Management: Plan and coordinate regulatory writing projects, in collaboration with Project Management department ensuring timely delivery of high-quality documents. Allocate resources and manage workloads effectively.
- Document Development: Write, review, and edit various regulatory documents, including clinical study reports, protocols, investigator brochures, and sections of regulatory submissions such as INDs, NDAs, MAAs, BLAs, and CTDs.
- Compliance: Ensure all documents comply with regulatory guidelines (e.g., ICH, FDA, EMA), company standards, and are scientifically accurate and of high-quality.
- Cross-Functional Collaboration: Collaborate with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to gather necessary information and ensure alignment on project goals and timelines.
- Quality Control: Work with Quality Control department to implement and maintain quality control processes to ensure the accuracy and consistency of all regulatory documents.
- Training and Development: Develop and deliver training programs for the regulatory writing team to enhance their skills and keep them updated on regulatory requirements and industry best practices.
- Strategic Input: Provide strategic input on regulatory submission planning and contribute to the development of regulatory strategies.
The selected candidate will also possess:
- Advanced degree in life sciences (MS/PhD/MD/PharmD preferred)
- 3+ years of regulatory writing/medical writing and submission experience
- Excellent written and verbal communication skills.
- Strong organizational and project management skills.
- Ability to manage multiple projects and deadlines.
- Proficiency in Microsoft Office and familiarity with document management systems.
- Detail-oriented with strong analytical and problem-solving abilities.
- Leadership and team-building capabilities.
- Ability to work effectively in a fast-paced, dynamic environment.
- Strong interpersonal skills with the ability to collaborate effectively across teams.
Salary Range: $120k-150k/yr
For immediate and confidential consideration, please email your resume to aaron@simplybiotech.com or call 858.427.3668 . More information can be found at www.simplybiotech.com