Medical Writing for Medical Devices and Healthcare
Why is Nicole a leader in medical writing and healthcare?
Nicole has a record for uncompromising integrity in compliance standards, providing direction for medical device companies. Inspiring team performance and internal/external partnership-building. A servant leader who motivates high-performing teams to provide exceptional clinical care, meet timelines, exceed patient care expectations, and fuel organizational healthcare transformation.
What experience can she bring to our organization?
Conceived and delivered strategic initiatives to drive adoption and optimize utilization of CER and CEP standards, SOPs and healthcare regulations. A founder who road-mapped the launch of the first outpatient specialty eating disorder clinic (Behavioral Nutrition, Inc.) licensed by the Department of Public Health in Massachusetts. Her proven track record of cost savings and fiscally responsible decision making provides added experience to her consulting roles.
Where can she provide the most value to our organization?
As the author of over 60 Clinical Evaluation Reports (CERs) and related regulatory documents for Class III, IIa, IIb, and I state of the art medical devices, she is a subject matter expert in compliance and new product development initiatives. She has worked with cross-functional teams to create corporate and divisional level Standard Operating Procedures (SOPs).
With more than 15 years of experience in medical writing, Nicole has authored a medical chapter, 7 scientific publications, a white paper, and gap analysis reviews on medical devices. She has consulted for Covidien, Medtronic, J&J, Abiomed, and Hologic.