5 Associate Director Regulatory Affairs Cmc And Devices jobs in Boston

Site: Mass General Brigham Incorporated

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

Responsible for combining research in biology, medicine, and health-related studies with information technology in order to collect and interpret data covering a range of fields, such as genetics or pharmaceutics. This role develops mathematical models, conducts dynamic simulations, and analyzes patterns in biological systems.

Does this position require Patient Care?
No

Essential Functions

• Independently design and execute bioinformatics analyses and research projects on small to mid-scale projects.

• Develop and optimize data analysis pipelines and workflows.

• Collaborate with scientists and researchers to define analysis goals and interpret results.

• Provide technical expertise and support for bioinformatics tools and software.

• Train junior scientists and provide technical guidance.

• Analyze data quality and integrity of data output from existing algorithms as part of the complex, multi-step specimen tracking and reporting process, across multiple systems and web-based interfaces.

• Develop new, innovative tools to enhance quality assurance reviews and improve assay and system performance.

• Design and apply novel computational methods/bioinformatics algorithms, machine learning models for building data models and tools using various software and statistical tools to aid in the analysis and interpretation of genetic data, clinical data, and images (NGS Algorithm development, Machine Learning).

• Analyze large molecular datasets from tumor sequencing to critically review and evaluate specimen testing results, working closely with faculty and staff to troubleshoot problems, recommend technology-based solutions, or determine computational strategies.

Qualifications

Education
Bachelor's Degree Computational Biology required or Master's Degree Computational Biology preferred

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials

Experience
Computational Sciences Experience 3-5 years required

Knowledge, Skills and Abilities

• Demonstrated experience in infrastructure, programming languages, and computational sciences.
• Demonstrated ability working with open-source bioinformatics software.
• Possess strong analytical skills, including critical thinking, data modeling, problem solving, and troubleshooting.
• Strong organizational and interpersonal skills.
• Ability to effectively communicate, both orally and in writing, to all levels of staff.
• Excellent time management skills.

Additional Job Details (if applicable)

Physical Requirements

• Standing Occasionally (3-33%)
• Walking Occasionally (3-33%)
• Sitting Constantly (67-100%)
• Lifting Occasionally (3-33%) 20lbs - 35lbs
• Carrying Occasionally (3-33%) 20lbs - 35lbs
• Pushing Rarely (Less than 2%)
• Pulling Rarely (Less than 2%)
• Climbing Rarely (Less than 2%)
• Balancing Occasionally (3-33%)
• Stooping Occasionally (3-33%)
• Kneeling Rarely (Less than 2%)
• Crouching Rarely (Less than 2%)
• Crawling Rarely (Less than 2%)
• Reaching Occasionally (3-33%)
• Gross Manipulation (Handling) Constantly (67-100%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Remote Type

Hybrid

Work Location

75 Francis Street

Scheduled Weekly Hours

0

Employee Type

Per Diem

Work Shift

Day (United States of America)

Pay Range

$45.17 - $65.74/Hourly

Grade

7

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:

0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.