Medical Affairs Specialist

Medical Affairs Specialist

Requirements

• MD, PhD, NP, PA, PharmD, RN, LPN/LVN or equivalent practical experience with at least 5 years of experience in or combination of experience in clinical care, medical device, biotech, hospital administration or pharmaceutical industry
• Strong communication skills with the ability to respond to verbal and written inquiries at all levels including executives, team members and healthcare providers
• Sound clinical decision-making with expected examples of successful implementation
• Strong interpersonal and relationship building skills with an expectation to lead by influence
• Adaptable and welcoming of change and willingness to explore and implement process improvements
• Advanced organizational and time management skills; experience in project management to drive initiatives forward successfully
• Intermediate level of comfort with Microsoft Office, (including strong experience Excel) Teams/Sharepoint, OneNote, etc.
• Understanding of statistics as it relates to clinical studies and interpretation of medical literature
• Medical writing inclusive of medical assessments, abstracts, clinical summaries and presentations
• Skills in complex analytic problem solving; ability to recognize potential obstacles and work to resolve them within set timelines
• Expertise in scientific and research methodology, medical device regulations and guidelines.
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which the company complies.
• Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Responsibilities

• Cross-functional risk management activities, including but not limited to support patient safety evaluations, documentation of risk/harm stratifications, management of health hazard evaluations (HHEs) and other risk assessments, review of risk document updates
• Complaint medical assessment, narrative writing, and other complaint processing activities for clinical studies and post market surveillance
• Develop, implement, and improve templates and standardization of processes for reportable event follow-up and regulatory submissions
• Clinical input and medical writing support of regulatory reports, i.e., Clinical Evaluation Reports (CERs), regulatory submissions, formal requests for additional information (RFAIs)
• Manage requests for medical information, utilizing appropriate cross-functional input to create and standardize responses
• Participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data
• Medical input and content expertise, implemented in the following areas: performance of comprehensive literature searches to inform clinical decision-making and competitive benchmarking, development of clinical summaries, white papers or responsive documents, inform and guide support of clinical, R&D, and marketing initiatives, support of external and internal training
• Off-label program, including but not limited to documentation of off label inquiries and responses including quarterly and annual reports as requested, creation of standard response letters in adherence with FDA guidance, knowledge of FDA procedures guiding off label policy
• Perform other duties as assigned

Preferred Qualifications

No preferred qualifications provided.