Nancy Gerber Email and Phone Number

Edit scientific manuscripts for a small, multidisciplinary clinical pharmacy/medical journal. Edit for content, clarity, consistency, journal style, and grammatical correctness. Article types include reviews of therapeutics (e.g., information on new drug, comparison of several drugs for same indication), original research articles (publication of clinical research results), and case reports. Work with authors to perfect their writing, involved in many phases of publication (selection of peer reviewers, review of revised document, editing, interpretation and incorporation of author changes, production elements such as tables and figures), help manage external clients to adhere to quality and timeline expectations, and developed and update journal style guide.

Supervised and trained medical research associates, safety data specialists, and support staff for North American Medical Services at a large contract research organization, participated in marketing and sales initiatives, and assisted the medical team on select projects.

Worked closely with the medical staff to monitor the safety of different drugs undergoing clinical trials. Tasks included reporting serious adverse events (SAEs) to clients, writing narratives for the Food and Drug Administration, developing project-specific SAE procedures, implementing SAE tracking systems, coordinating processes with multiple medical staff for large global studies, answering site and internal staff medical questions, reviewing laboratory reports for significant values and following up with sites concerning patient safety, and reviewing protocols and listings for medical inconsistencies and inaccuracies.

Responsibilities included clinical trials monitoring, site evaluation and study initiation, and data collection and quality control review of data collected at trial sites to ensure compliance with multiple protocols, FDA regulations, and GCP guidelines for Phase II, III, and IV trials.

Performed clinical research associate tasks as well as acted as liaison for international and domestic contract research organization during trials of antimicrobial-coated shunt. Regulatory responsibilities included writing regulatory submissions for new neurosurgical products (e.g., 510K, IDE), assisting international affiliates in registering products, and being a member of the Medical Device Reporting Committee.

Wrote user and service manuals for neurosurgical instruments and equipment, wrote and edited standard operating procedures, edited technical specifications and engineering change orders, and worked closely with new product development teams.

Staff editor for the health care consulting section, edited proposals, final reports, and presentations, supervised the section's graphic arts department, and researched medical technologies and health care companies.