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Lead Medical Affairs Specialist
2 months ago
JOB TITLE
SENIOR MEDICAL AFFAIRS ASSOCIATE
DEPARTMENT
CLINICAL & MEDICAL AFFAIRS
OBJECTIVE OF THE ROLE
The primary goal of this position is to support the development, oversight, and dissemination of medical and scientific information resources, particularly concerning the company's product portfolio and the broader medical landscape.
KEY RESPONSIBILITIES
- Information Management: Track, develop, and share pertinent information related to products and specialties. Assist in the formulation and execution of publication strategies, and ensure the effective communication of clinical outcomes both internally and externally, including at scientific conferences and through peer-reviewed journals. Maintain comprehensive product and specialty information across various databases, ensuring proper tracking and documentation.
- Regulatory Collaboration: Lead the review and development of educational, technical, and promotional materials. Provide insights into global clinical strategies and contribute to regulatory submissions and documentation.
- Liaison with Healthcare Professionals: Foster and manage relationships with professional associations and healthcare providers to enhance knowledge dissemination through the company's scientific committee. Collaborate with physicians, learned societies, and organizers of scientific events. Assist in the management of the scientific committee, investigator-initiated studies, and other relevant committees.
- Marketing Support: Offer scientific expertise in the creation and design of promotional materials and events, enhancing product-specific and general scientific knowledge. Participate in scientific meetings and congresses as necessary.
- Research & Development Support: Engage in all phases of clinical development, including study design and monitoring, by providing timely medical and scientific insights. Lead the preparation and evaluation of clinical documents such as protocols, study reports, and regulatory submissions.
- Medical Writing: Conduct analysis of clinical datasets and communicate findings through reports, publications, and presentations.
- Training Development: Contribute to the medical and scientific training curriculum for the organization, preparing and delivering training as required.
- Mentorship: Provide guidance and support to Medical Affairs Associates.
COLLABORATION WITH OTHER DEPARTMENTS
This role necessitates collaboration with various departments, including Management, Sales, Marketing, Clinical Operations, R&D, and Quality Assurance, playing a pivotal role in cross-functional initiatives that require clinical expertise.
QUALIFICATIONS & SKILLS
- Exceptional verbal and written communication skills in English, with a focus on scientific and technical writing.
- Thorough understanding of the clinical research process and regulatory requirements.
- Strong interpersonal skills, self-motivated, and a positive attitude.
- Meticulous attention to detail and organizational skills.
- Ability to manage multiple projects and tasks effectively.
- Quick learner with the capacity to grasp diverse subject areas.
- Familiarity with medical information databases.
- Proficient mentoring and teaching abilities.
- Strong problem-solving, judgment, and decision-making capabilities.
EDUCATION & EXPERIENCE
- Bachelor's degree in engineering, science, or a related healthcare field.
- Minimum of two years' experience in clinical research, preferably in medical devices.
- Prior experience in medical affairs, regulatory, or biostatistics is advantageous.
- Experience in scientific and technical writing, including clinical reports and regulatory documents.
- Proficient in Microsoft Office Suite, particularly Word and Excel.
- Willingness to travel as required.
