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Integrated Product Development Associate
at Rho, Inc.
- Regular Full-Time
Rho is seeking candidates for an Integrated Product Development Associate - chemistry, manufacturing, and controls (CMC) position. This role is intended for individuals aspiring to lead full product development programs within the pharmaceutical industry, with a focus on CMC. To this end, the candidates will first be exposed to various 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, 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 impact an overall understanding of the entire product development process.
Duties of the Integrated Product Development Associate - CMC include but are not limited to:
- Assists in writing CMC 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).
- Researches current literature to assist in the planning, design and execution of CMC activities in product development programs.
- With some supervision, interacts with sponsors to determine the format, design, and direction of CMC documents and reports.
- Provides CMC information to contribute to the development of clinical study documents, including investigational drug brochures, study protocols, and study reports.
- Under supervision, reviews available CMC data and information for sponsor development programs to identify gaps and deficiencies, and makes recommendations to remediate gaps.
- Coordinates poster and manuscript development for CMC-related content, with input from subject matter experts. 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.
- A PhD, PharmD, or MD degree and excellent reasoning capabilities, scientific acumen, and writing capabilities are required. For this CMC position, a PhD in Chemistry or related subject area is preferred.
- 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 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 its 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 Visio.