Job Description
Pay 60-80/h depending on experience
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- May determine methods and procedures on new assignments.
- Serves as an in-house consultant.
- May act as spokes person on corporate research/technology/development and advise senior management.
- Leads in the use of professional and scientific concepts to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways.
- Synthesizes multiple data sources and draws general, non-obvious conclusions.
- Defines complex problems, develops approaches and develops experiments with sound judgment.
- Assists in development of regulatory filings.
- Interfaces with various departments, customers and partners.
- Assists the Commercial team in developing concepts.
- Puts work practices in context with larger team and participates in the implementation of change when required.
- Plans and coordinates activities with other team members.
- Writes and/or approves complex reports and protocols.
The ideal candidate will have the following:
- Phase 2 or late-stage drug development experience
- Experience with data analysis and interpretation as an understanding of safety and PV principles
- Well-versed in clinical data review, including: data listings, patient profiles, drug class identification and adverse event review
- Ability to evaluate, interpret and present complex scientific data
Requirements:
- A PharmD or PhD in a scientific discipline is required. Equivalent experience may be accepted.
- A minimum of 5 years work experience in a pharmaceutical, CRO or biotech environment required. Experience in immunology (Rheumatoid Arthritis, Atopic dermatitis, ulcerative colietis, alopecia areata, etc.) highly preferred.
- Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
- Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment.
- Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work.
- Must possess good oral and written communication skills.
- Ability to present technical information to both technical and non-technical audiences is required.
- Must be able to demonstrate sound judgment.
- Must be able to demonstrate problem solving capabilities.
- Strong organizational skills are required.
- Good computer skills are required.
- Working knowledge of MS word, Excel, Power point is a plus.
- Experience working in an FDA regulated environment and knowledge of current GMPs.
Job Tags
Remote job, Contract work, Work experience placement,