RHO

  • Integrated Product Development Associate

    Job Location US-NC-Chapel Hill
    ID
    2018-1398
    Type
    Regular Full-Time
  • Overview

    Rho is seeking recent post-Doctoral candidates as Integrated Product Development Associates.  The Integrated Product Development Associate position is intended for individuals aspiring to lead full product development programs within the pharmaceutical industry.  To this end, the candidates will first be exposed to all documents prepared as part of the product development process (including integrated product development plans, clinical trial applications, sections of Investigational New Drug applications, preclinical and clinical study protocols, investigator brochures, supporting statistical documents, integrated clinical/statistical final study reports, and sections of marketing applications.)  This on the job training will be supplemented with classroom lectures and workshops to impart an overall understanding of the entire product development process.

    Responsibilities

    Duties of the Integrated Product Development Associate include but are not limited to:

    • Researches current literature to assist in the design of clinical studies. 
    • With some supervision interacts with sponsor to determine the format, design, and direction of clinical/statistical reports.
    • With some supervision reviews and edits statistical analysis plans and statistical reports written by biostatisticians for clarity and accuracy.
    • Contributes to investigational drug brochures; summarizes animal and clinical studies, and draws conclusions as to the potential safety of the drug under study.
    • Assists in writing documents to support regulatory submissions including, but not limited to, clinical trial authorizations (INDs, CTAs), marketing authorization applications (NDAs, BLAs, NDSs, MAAs), device authorizations (IDEs, 510Ks, PMAs).
    • Interacts with the product sponsor and designated authors to determine the content and direction of scientific publications.  Interacts with meeting organizers and journal editors, as appropriate. 
    • Coordinates poster and manuscript development with input from physicians, biostatisticians, pharmacologists, and regulatory personnel.  Edits manuscripts according to the journal or meeting style guidelines.  Obtains author, sponsor, and internal approval of the final versions of abstracts, posters, and manuscripts.  Ensures compliance with the SOPs for publication development.

    Qualifications

    •  A PhD, PharmD, or MD degree and excellent reasoning capabilities, scientific acumen, and writing capabilities are required. 
    • In addition, candidates should have a minimum of two years’ work experience (e.g., student internships, postdoctoral fellowships, laboratory positions, or project management).
    • Working knowledge of medical terminology and basic statistical concepts is strongly preferred.  
    • Must have experience with medical, pharmaceutical, and/or research concepts.
    • Experience with principles of or project work involving Chemistry, Manufacturing, and Controls (CMC), nonclinical safety research, or clinical study design, management, or participation is desirable.
    • Qualified candidates will possess basic editorial and proofreading skills and will understand and perform well the process of writing (outlining, drafting, revising, and reviewing.) 
    • Must be detail-oriented, thorough, and methodical. 
    • Must be able to reduce voluminous complex scientific data to it essence in tabular or summary form.
    • In addition, must be adaptable to changes in work duties, responsibilities, and requirements.
    • Qualified candidates will be team-oriented individuals who keep others informed of the progress and status of writing projects.
    • Must be able to perform numerous tasks simultaneously without losing sight of overall objectives.
    • Proficient with software packages including, but not limited to:  Microsoft Word, Excel, PowerPoint, Project and Vision.

    EOE. Veterans/Disabled

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed