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RssSenior Regulatory Writer (17 years experience)

I am seeking to end my present consulting status and return to an in-house position where continuity of projects is more realized. I have over 15 years experience writing regulatory medical documents that comprise CFR21 356h NDA/BLAs and eCTDs deliverables to the FDA/EU/Canadian regulatory authorities. I have written approximately 85 CSRs and can confidently say that ~40 of these were NCEs, early phase I/II and some phase III/IV as well. I have mastered safety, PD, pK and preliminary efficacy assessments (i.e., Phase I/II, III and first in human). About 30% of all work obtained over my career involved Protocol writing to final approval. Larger scope eCTD documents I have authored include SOPs, IBs, PSURs, and Module 2, some 3, 4 and 5, and 356h-formatted ISS and ISE sections. In terms of the needs of a growing Regulatory Medical Writing Department, I have developed and implemented several ICH regulatory document templates used in IBs, Protocols and Phase I through III CSRs (i.e., conforming with the ICH E3 CSR guideline [1996]). Also, I have developed mock table shells working with statisticians prior to Final biostats runs that assure SAPs specs while assuring the completeness of submissions from a writer’s perspective. And sometimes in response to these crucial planning steps, I have reverse-designed the report template to existing Summary Text Tables and Patient Data Listings formats to be run by biostats to ease and speed report assembly. I have been an Associate Director in 3 companies where I initiated and managed the MW process. I also built the head count of my department, while developing the day to day interaction with larger facets of data management, biostatistics and regulatory affairs. In each of these cases, larger corporations acquired these start-up/small companies, and my role was either reduced to lesser responsibilities or eliminated entirely immediately after their purchase. As a result, I returned to consulting. Again, I seek the regularity of an in-house job. I look forward to your response.

Clinical Research

Titusville, FL

About Me

Industry:

Science & Biotech

Occupation:

Clinical Research
 

Education level:

Master

Will Relocate:

Yes

Location:

Titusville, FL

Keywords