Job summary
Job post source
This job is directly from NAMSA
Job overview
The Study Director at NAMSA oversees preclinical studies ensuring compliance with regulations and client requirements, contributing to medical device safety and development.
Responsibilities and impact
The role involves coordinating study tasks, serving as primary client contact, ensuring compliance with GLP and other regulations, analyzing data, preparing reports, managing study schedules and budgets, leading teams, and interacting with clients and regulatory bodies.
Experience and skills
Requires a Bachelor's degree in a scientific discipline with at least two years of lab experience or a Master's/PhD with one year of relevant experience; knowledge of GLP, animal welfare, and medical device development is important.
Work environment and culture
NAMSA values integrity, customer experience, talent development, agility, collaboration, and diversity, fostering an innovative and supportive work environment.
Company information
NAMSA is a pioneering independent company specializing in medical device materials safety testing since 1976, contributing to industry standards and supporting clients throughout product development.
Unique job features
The job involves working with advanced medical device testing methods, regulatory interactions, and exposure to laboratory animals and specialized equipment in a BSL2 environment.
Company overview
NAMSA, or the North American Science Associates, is a global leader in the medical research organization sector, providing comprehensive services to accelerate product development for medical device, in vitro diagnostic, and combination product manufacturers. They make money by offering a range of services including regulatory consulting, laboratory testing, clinical research, and reimbursement strategies, helping clients bring their products to market efficiently and compliantly. Founded in 1967, NAMSA has a rich history of innovation and expertise in the medical device industry, with a strong emphasis on delivering high-quality, scientifically-driven solutions to its clients worldwide.
How to land this job
Position your resume to highlight your experience coordinating and managing preclinical studies, emphasizing your role in study initiation through completion and client communication.
Focus on your knowledge of GLP, GMP, ISO regulations, and your ability to ensure compliance with quality system regulations and NAMSA SOPs, as these are critical for the Study Director role.
Apply through multiple platforms including NAMSA's corporate career site and LinkedIn to maximize your application visibility and reach.
Connect with current Study Directors or team members in the MedTech or preclinical divisions at NAMSA on LinkedIn; start conversations by referencing recent MedTech innovations or asking about their experience with regulatory interactions like FDA or IACUC submissions.
Optimize your resume for ATS by incorporating keywords such as 'GLP compliance,' 'study coordination,' 'preclinical study management,' 'client communication,' 'regulatory submissions,' and 'data analysis' to pass automated screenings.
Use Jennie Johnson's Power Apply feature to automate tailored resume customization, identify multiple application channels, and find relevant LinkedIn contacts, freeing you to focus on networking and interview preparation.
Jennie Johnson works for you!
Here’s what we do to make sure you’re successful:
Targeted Resume Revamp:
We expertly craft your resume to navigate Applicant Tracking Systems (ATS) and showcase your qualifications, making you stand out as a top-tier candidate.
Job Description Dissection:
Unpack the job posting with expert analysis, ensuring your application hits every key requirement.
Bespoke Cover Letter:
Capture the attention of hiring managers with a personalized cover letter that highlights how your skills align perfectly with the job's needs.
Interview Mastery:
Prepare for interviews like a pro with likely questions, strategic answers, and insightful questions for you to ask, setting you apart as an informed candidate.
Direct Application Insights:
Receive tailored advice on the best places to apply, ensuring your applications are seen by the right employers.
Skills and Gaps Assessment:
Identify and close critical skills gaps to position yourself as the best-fit candidate for your ideal job.
Personalized Email Pitch:
Make a memorable first impression with an email template crafted to engage potential employers and initiate meaningful conversations.
In-depth Research Guide:
Leverage comprehensive research tools to gather effective insights on companies, industry trends, and role-specific challenges.
Detailed Company Analysis:
Gain in-depth understanding of your prospective employer, giving you the edge in applications and interviews.
Strategic Candidate Overview:
Understand your unique value and why companies would want to interview you, highlighting your background and positioning.