Regulatory Affairs Specialist
1 week ago
We are seeking a highly skilled and detail-oriented Medical Coordinator to join our team at BioTalent. As a Medical Coordinator, you will play a critical role in managing the Medical, Legal, and Regulatory (MLR) review process for our clients' promotional materials and communications.
Key Responsibilities- MLR Process Management
- Coordinate and facilitate the review and approval of promotional materials, ensuring compliance with relevant medical, legal, and regulatory standards.
- Act as the central point of contact between internal teams (Marketing, Medical Affairs, Regulatory, Legal) and external stakeholders to ensure timely and efficient review processes.
- Schedule and manage MLR meetings, including agenda preparation, meeting facilitation, and follow-up on action items.
- Documentation & Compliance
- Ensure all promotional materials are adequately documented, version-controlled, and compliant with local, regional, and global regulatory requirements.
- Maintain accurate records of MLR review outcomes, approvals, and any required amendments.
- Monitor changes in regulatory guidelines and ensure that all materials reflect the most current standards.
- Stakeholder Communication
- Collaborate with cross-functional teams to address questions, provide guidance on MLR processes, and ensure alignment on review timelines and expectations.
- Serve as the liaison between MLR committee members and content creators to facilitate smooth and effective communication.
- Process Improvement
- Identify and implement process improvements to enhance the efficiency and effectiveness of the MLR review process.
- Develop and maintain standard operating procedures (SOPs) for MLR reviews and ensure that all stakeholders are trained and informed about these processes.
- Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field.
- Minimum of 3 years of experience in a similar role within the pharmaceutical, biotechnology, or medical device industry.
- Strong knowledge of regulatory requirements and industry standards related to promotional materials and communications.
- Proven project management skills with the ability to manage multiple priorities and deadlines.
- Excellent communication and interpersonal skills, with the ability to work effectively in a virtual, cross-functional environment.
- Proficient in using document management systems and collaborative tools (e.g., Veeva Vault, Adobe Acrobat, Microsoft Office Suite).
- Fluency in English; additional European languages are a plus.
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