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@kateblackerby
Member since February 4, 2016
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kateblackerby

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I have always enjoyed writing, for my own pleasure, and whenever the opportunities presented itself in academics or career. I worked in Publication Planning in pharma for 5 years, creating abstracts and publications, editing versions, and crafting strategic plans. Prior to that, I was in Clinical Operations for 10 years, and honed my writing skills through study document creation for items like monitoring plans, clinical study reports, protocols, and training materials for sites. I enjoyed this so much that I also sought out extra work on regulatory documents like briefing books and safety and efficacy sections of drug applications. I didn't have to search too hard, my skills and work ethic had colleagues actively seeking me out for assistance on their projects. Now, I am interested in paving my own career path.
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Portfolio

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Experience

Senior Manager, Medical Sciences

Nov 2014 - Mar 2016 (1 year)

Operational leader of Collaborative Research (phase 4) cross-functional and cross-company team responsible for development of strategic objectives and execution of those tactics; oversight of implementation and adaptation of compliant processes, systems and budgets in support of the research, IIT, medical education and sponsorship programs; support of global publication strategy through management of achievement of program deliverables; general input into target product profile

Manager, Research and Publications

Jul 2012 - Nov 2014 (2 years)

Responsible for publication planning and content development; synthesis with global collaboration partners; external research including phase 4 and other collaborative studies and IITs; sponsorship, medical education grants, and charitable support

Manager, Publications

Oct 2010 - Jul 2012 (1 year)

Responsible for spearheading publication plan for products in late stage development, identification of additional publication projects from IITs and other collaborations and facilitation through appropriate oversight and review. Management of publication tracking databases including training and identification of necessary business enhancements.

Clinical Trials Manager

Jul 2007 - Oct 2010 (3 years)

Headed cross-functional trial teams and vendors from study concept through report writing including protocol development, design and review of study documents, and vendor management. Experience with all phases of development, with special focus on behind course late stage trials.

Inhouse CRA

Jul 2004 - Jul 2007 (3 years)

Responsible for performing clinical monitoring tasks and duties in accordance with regulations. Managed, coordinated, and supported clinical monitoring activities. Reviewed and assisted with drafting of trial documents, processes, and training documents for internal teams and sites.

Education

Bachelor Science, Public Health

2011 - 2016 (5 years)

Publications

A pilot study of HDSD daptomycin for the treatment of cSSSI caused by gram-positive bacteria

Publication of safety and efficacy results for phase 2 clinical trial of high-dose short duration used to treat patients with complicated skin and soft tissue infections caused by gram-positive bacteria versus standard therapy.

Certifications

  • US English Level 2
    100%
  • US English Level 1
    95%
  • Academic Writing 2
    80%
  • Academic Writing
    78%

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