Employment Type : Full-Time
Job Description SummaryJob Description The Principal Analyst is the subject matter expert in complex data analysis and performs work independently with minimum supervision. May supervise/act as project lead and provide charts, graphs, data analytics to the Medical Writers to incorporate into regulatory and clinical deliverables as necessary. Essential Duties and Position Responsibilities Responsiblefor leading and ensuring completion of all Medical Writing/Analytics Projects by due date May supervise Medical Writing Analysts including reviewing work products, managing performance, coaching, training and development Acts as Project Co-leader (with Senior LevelMedical Writer) for all Medical Writing Projects Performs systematic literature searches utilizing a variety of peer reviewed databases Creates and updates statistically based Evidence Matrix to supportClinical Evaluation Reports Creates tables and figures from various data sources including but not limited to FDA MAUDE, FDA TPLC,and other government complaintdatabases (MHRA,SwissMedic,BfARM) Create various tables and charts necessary for the completion of medical writing deliverables from systematic literature reviews Create chartsfrom Distiller for medical writing document as necessary Quality check all calculations throughout the reports for accuracy Works collaboratively withvarious cross functional group including but not limited to the PMS Group, Field Assurance, Clinical, Medical, Regulatory Affairs and Marketing Qualifications, Knowledge, and Skills Required: Minimum10years with B.S. degreelife sciences, engineering or relevant discipline Minimum3years' experiencewith supervising a high producing team Extensive experience in statistical analysis of clinical data Extensive experience analyzing and organizing complex datainto easy to understand and meaningful charts, tables and figures Extensive experiencewith Microsoft Word, Excel, PowerPoint Experience with project management Working knowledge of clinical research, device development processes, regulatory requirements, good clinical and data management practices Excellent English Language skills, especially in writing and proof reading Clinical or scientificresearch background required Extensive knowledge with EU MDR, MEDDEV 2.7.1 Rev 4, GSPR, and IMDRF required Excellent understanding of scientific or clinical research and methods required Strong oral and written communication skills Excellent interpersonal skills Must be able to handle a variety of projects at the same time Strong prioritization skills required Ability to motivate and empower diverse teams Have an inclusive mindset in working with others Ability for potential travel (up to 10%) Key Relationships Internal Relationships: Medical/Clinical Affairs Regulatory Affairs Specialist Product Development Quality Assurance PMS Group Marketing Document Control External Relationships: Corporate Legal and Regulatory Affairs Health Ministries Notified Bodies, and regulatory agencies (i.e.FDA) Scope and Impact of Position: This key position willensure generation and maintenance of clinical statistical evidence to support regulatory submissionsfor all BDI Surgical Business Unit products. This includes a growing line of mesh prosthetics, biologicimplants, fixationsystems, andsurgical instrumentsto complement innovative techniques forvarious surgical procedures.In addition to this extensive suite of products, theBiosurgeryfranchise is deliveringa growingline of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic,cardiovascular,and other surgical specialties. Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. #LI-PRO