Experience

Merigold

• United States
• Biotechnology Research
• 1 - 100 Employee

• Lead Clinical Trialist

  • Dec 2020 - Present



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director, Medical Writing

  • Nov 2018 - Nov 2020

  Responsible for maintaining an overview of the medical writing team and ensuring proper resourcing and global footprint given the current and anticipated workload/study pipeline. Responsible for developing the vision for the medical writing group and communicating associated goals and initiatives including timelines and progress. Manage and develop medical writing managers and other senior medical writing team members. Represent medical writing during internal and external meetings and events as necessary. Publication planning and execution. Show less

• Manager Medical Writing

  • Jun 2017 - Oct 2018

  Responsible for developing, coaching, mentoring, and managing a global team of medical writers including hiring our first team members in Hyderabad, India and Shanghai, China and for developing 3-month long internship opportunities within medical writing for PAREXEL Academy trainees. Responsible for representing the medical imaging, medical writing unit and for participating in a cross-functional leadership group across all PAREXEL medical writing groups to align marketing, training, and resourcing initiatives and create efficiencies. Responsible for developing and leading efficiency and consistency initiatives and for thought leadership within medical writing. Show less

• Principal Medical Writer

  • Apr 2016 - May 2017

  In addition to MW II responsibilities, also responsible for line management and mentoring of junior medical writers, central content/template development and maintenance, and cross-functionality collaboration.

• Medical Writer II

  • Aug 2014 - Mar 2016

  Research, create, edit, and coordinate the development of independent review charters (IRC), reviewer manuals, imaging case report forms (CRFs), and other clinical documents intended for submission to the FDA or other regulatory authorities. Also responsible for the development of these or other documents which may not be submitted to the FDA or other regulatory authorities but are recommended to ensure the quality and consistency of independent reviews.Serve as the main client contact for IRC development, including presenting and leading client discussionsCombine understanding of current product offerings and existing solutions with knowledge of medical and scientific concepts in order to meet the customer’s requirementsEnsure that standards as described in department documentation upholds the following goals: increased efficiency, enhanced document quality, and content and format standardization Show less

• Imaging Operations Lead

  • Oct 2011 - Oct 2014

  Responsibilities included overseeing project team in site qualification, processing of imaging examinations and query management, assisting the project manager in the development and controlling of timelines, deliverables, and project resource requirements, developing and editing study related procedure manuals, assisting the project manager in setting up the study specific applications, managing the data reconciliation process together with the client or CRO data management group, acting as the main point of contact for the global imaging research team members, training investigator sites in image acquisition technique in accordance with study protocols, interacting with and serving as the point of escalation for clients and/or academic centers and independent reviewers/subcontractors, supporting the project manager during kick-off and other client meetings, and presenting image processing procedures during bid defense meetings. Show less

• Senior Imaging Research Associate

  • Mar 2006 - Oct 2011

  Responsibilities include performing computer-based analysis on medical images for clinical trials, converting medical image data to digital format, developing and coordinating study related activities in compliance with FDA Regulatory Requirements, as well as interacting with investigator sites to ensure follow-up on imaging-related issues. As a lead IRA, responsible for attending investigator meetings/training sites on image acquisition guidelines, developing image-processing procedures, writing operations manuals, training team members and dealing with new issues as they arise. Show less

• Imaging Assistant

  • Sep 2005 - Mar 2006

  Responsibilities include providing initial clinical trial site contact and support to the Perceptive project team(s), helping to develop and coordinate study related activities in compliance with FDA Regulatory Requirements, using computer systems to convert medical image data to digital form, masking of medical images, QC of medical images and maintaining a database of medical images and associated results.



Entangled Publishing

• remote

• Editorial Intern

  • Aug 2013 - Aug 2014

  Reading submissions (minimum of 2-3 manuscripts per week), writing reader reports, and providing recommendations for rejection or acceptance of submitted manuscripts. Reading submissions (minimum of 2-3 manuscripts per week), writing reader reports, and providing recommendations for rejection or acceptance of submitted manuscripts.



Pulmatrix Inc.

• Biotechnology
• 1 - 100 Employee

• Engineering Intern

  • Sep 2004 - May 2005

  •Refined an in vitro model of the upper airways to test novel formulations for bioaerosol suppression capabilities. •Analyzed the viscoelastic properties of a mucus mimetic using an ARES strain-controlled oscillatory rheometer. •Characterized novel formulations in terms of surface tension using a SITA tensiometer. •Used an Optical Particle Counter to determine the effect of novel formulations, in terms of particle formation suppression, when nebulized onto a mucus mimetic. •The capstone project accentuated technical communication by involving a written proposal, monthly progress reports, a final report and an oral presentation at a professional conference. Regulatory and IP issues were also addressed. Show less



NAMOS, GmbH

• Research Technician

  • Jun 2004 - Aug 2004

  •Helped to develop a bed-side test (HIRUQUANT) to determine Hirudin levels in the blood. •Performed experiments to advance Sol-gel coating technology. •Performed preliminary work on the development of an electrically applied ink for titanium implants. •Helped to develop a bed-side test (HIRUQUANT) to determine Hirudin levels in the blood. •Performed experiments to advance Sol-gel coating technology. •Performed preliminary work on the development of an electrically applied ink for titanium implants.



Deltakeeper

• Volunteer

  • Jun 1998 - Aug 2001

  •Performed water quality analysis by testing pH levels, dissolved oxygen levels, and regulating fish death. •Performed water quality analysis by testing pH levels, dissolved oxygen levels, and regulating fish death.