Job Title – Associate Medical Scientist

Location - San Jose, CA

Duration – 12+ Months Contract

Total Hours/week - 40.00
1st Shift

Work hours: 9am-5pm
Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Description:

Onsite 3 Must haves on the resume: 1) previous experience organizing presentations, posters or documents from clinical trial results , 2) excellent written and verbal communication skills and 3) Biotech Industry experience.

Associate Medical Scientist:
Responsible for setting work direction and completion of work tasks under supervision of the Medical and Scientific Affairs Management. Will provide input into product documents and presentations on behalf of the Medical and Scientific Affairs team who are responsible for safety of product. Interacts with internal stakeholders such as Project Core Team members, Global Clinical Development, Statisticians, Regulatory Affairs, Technical Writing, Marketing and Legal. May interact with investigators.
Must be knowledgeable about key aspects of simple to moderately complexity clinical studies to enable accurate inputs into Core Team product communication activities. Responsible for liaising effectively across functions, to review data from clinical trials for communication supporting BD products. Recognizes existing problems, develops recommendations, and successfully implements solutions of simple or moderately complex problems. Experience with systematic literature search, appraisal and reporting representing Medical and Scientific Affairs (as part of team) on specific projects/programs. Interacts with subject matter experts and potentially with investigators.

Key Requirements for Success:
Industry experience, understanding of product development process and leverage support from cross functional team members.
Excellent interpersonal and communication skills, including the ability to perform well in a highly matrixed environment, and as an effective member of a highly functioning multidisciplinary team
Excellent written and verbal communication skills; demonstrated ability to create, organize and maintain technical/medical documentation supporting regulatory submissions, and communication of results (conferences, publications, etc.)
Facilitates the creation of a schedule for deliverables for the program team, then revises and updates the schedule through the course of the program.
Hands-on work habit and down-to-earth personality with ability to solve problems and mitigate issues.
Solid knowledge of Good Clinical Practices, Regulations and Guidance, including Clinical Laboratory Standards relative to the conduct of clinical trials and evidence generation for in-vitro products.
Ability to manage project schedule, generate timelines, and deliverables under supervision.
Carries out tasks and activities that are defined in local business/operating plans.
Strong training and presentation skills and intermediate project management knowledge
Occasional national travel (10%)

Education and Experience:
Advanced Degree, Master's or MD or PhD or other allied health or other allied health degree/certification in a health-related or life science Required
A minimum 2 years of experience in a regulated industry environment, such as in vitro device, medical device, biotech, or pharmaceutical industries.

Assets
Individuals with previous direct experience presenting data from clinical trials experience within an IVD and/or medical device industry are highly desired.
Individuals with previous flow cytometry experience or clinical laboratory experience are desirable. For many roles at this client, assignment is contingent upon the