What are the responsibilities and job description for the Senior Publisher/Regulatory Operations Specialist position at Proclinical Staffing?
Senior Publisher/Regulatory Operation Specialist - Permanent - Remote
We are seeking a Senior Publisher/Regulatory Operations Specialist to join us in shaping regulatory strategies and ensuring seamless submissions. This role involves managing complex documentation workflows, upholding quality standards, and collaborating with cross-functional teams to enhance efficiency.
This is an ideal position for someone detail-oriented, proactive, and thrives in a collaborative setting.
Key Skills and Requirements:
- Proficient knowledge of IND/BLA/eCTD and other electronic submission guidelines.
- Background in Chemistry or Life Sciences.
- Experience with DocuBridge software.
- Familiarity with the pharmaceutical industry and regulatory affairs.
- Expertise in MS Office, Adobe Acrobat, and electronic/document/data management systems.
Main Responsibilities:
- Manage and oversee complex documentation workflows.
- Maintain high-quality standards in all regulatory submissions.
- Collaborate with cross-functional teams to drive operational efficiency.
- Navigate and implement electronic submission processes.
- Ensure compliance with regulatory requirements and guidelines.
