JOB TITLE

SENIOR MEDICAL AFFAIRS ASSOCIATE

DEPARTMENT

CLINICAL & MEDICAL AFFAIRS

JOB CODES

Job Codes assigned to Associates can be viewed on MasterControl via the Trainee InfoCard

MAIN PURPOSE OF JOB AND OBJECTIVES

To assist in the creation, monitoring, and sharing of medical and scientific information resources and knowledge specifically in the areas of the company’s products and generally in the medical field.

POSITION IN ORGANISATION

Reports To: Medical Affairs Manager

No Direct Reports

Deputises for: Medical Affairs Manager

Deputised by:  Medical Affairs Manager or Associate

KEY DUTIES

• Informational services: tracking, creating, and sharing information and knowledge relevant to products and specialty, assist in developing and implementing publications plans, and the reporting of clinical results internally and externally, at scientific meetings and through journal articles. Maintain product and specialty information on a variety of databases, tracking this information and filing as appropriate.

• Regulatory support: Lead or oversee and review written educational, technical, and promotional materials.. Provide input into the development of global clinical strategies, contribute to and advise on regulatory submissions and documents.

• Health care professionals and professional organizations liaison: supporting and leading efforts with professional associations, HCPs to create and disseminate knowledge via the company’s scientific committee, developing and maintaining relationships with HCPs to disseminate knowledge better. Interface with physicians, learned societies, and scientific meetings organizers. Assist in the coordination and management of the company’s scientific committee, investigator-initiated studies, and contribute to other committees (grants, publications, etc.) as required.

• Marketing support: providing scientific input and expertise in the design and construction of all promotional materials and events, contributing to increased knowledge and awareness with product-specific and general scientific knowledge and information. Attend and participate in scientific meetings, congresses and travel as required in the pursuit of these objectives.

• R&D and clinical support: contributing to all stages of clinical development including study design, initiation and monitoring, specifically via the provision of timely medical and scientific information. Lead the preparation and review of clinical documents such as protocols, study reports, study materials, clinical evaluation reports and regulatory documents such as submissions.

• Medical Writing: preparation and analysis of clinical datasets, interpretation and communication of results via reports, publications and presentations

• Training: contribute to medical and scientific curriculum for company-wide training and development; preparation of training and delivery as required.

• Mentoring of Medical Affairs Associates

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

This position requires cooperating with different company departments, such as Management, Sales, Marketing, Sales & Training, Clinical Operations, R&D, Logistics, Operations, Human Resources, Quality and the other team members within the department, leading or taking the role of facilitator in cross-functional initiatives that require clinical information.

QUALITY

REQUIREMENTS

• Excellent verbal and written skills (English), including scientific and technical writing/communication
• Solid understanding of the clinical investigation process and associated regulatory requirements.
• Good interpersonal skills, self-motivation and ability to retain a positive attitude
• Extremely detail-oriented and organized
• Ability to manage projects, including multiple tasks.
• Ability to learn new and diverse subject areas quickly.
• Familiarity (as a user) with medical information databases (such as PubMed)
• Strong mentoring and teaching skills
• Excellent problem solving, judgment and decision-making skills

QUALIFICATIONS & EXPERIENCE

• B.S. in engineering, science or a related health care field  
• Two years’ experience in clinical research (medical device is highly preferred).
• Previous experience in medical affairs, regulatory, and/or biostatistics (preferred).
• Experience with scientific and technical writing, such as clinical reports, clinical documents for regulatory submission, Congress presentations, and publications. 
• Excellent computer skills, including expertise in Microsoft Office Products, such as Word and Excel.
• International Mobility:
• Ability to travel up to 30% of the time.