- Proactive management of human factors engineering work across pipeline projects. Anticipate potential design/regulatory/quality risks, and develop actionable strategies following the latest industry and regulatory best practices and trends.
- Developing the strategy for and authoring Human Factors sections for health authority interactions and submissions. Interact with health authorities during face to face meetings and written responses.
- Lead human factors development activities for patient-centric device innovations
- Contribute to new product introduction efforts for parenteral combination product launch and on-market support by applying human factors principles and standard methodologies
- Collaborate with external Human Factors consultancies and develop vendor strategy appropriate for the overall parenteral pipeline.
- Engage with AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and best practices.
- Lead, mentor and manage a group of HF engineers.
- Be a voice of user-centricity across all product types in AstraZeneca.
- Be engaged with and influence Human Factors best practices externally across industry and with regulators
- Develop and find opportunities for improvement of internal Human Factors practices and associated business processes to ensure consistency, compliance and efficiency with internal business partners and counterparts
- Advanced knowledge in Human Factors engineering for combination products including a in-depth knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management. Ability to adapt human factors strategies to the evolving regulatory expectations in the combination product space.
- Experience in health authorities (FDA, EMA, Notified Bodies, and other regulators) submissions and associated interactions
- Experience with GxP responsibilities to provide applicable data and reports for health authority submissions and approvals. Familiar with health authority and quality audits.
- An understanding of the drug/device development process including a balanced perspective on how to integrate Human Factors work into these processes.
- Ability to build relationships with and manage external Human Factors consultancies to execute research activities
- Strong communication, organizational and technical problem-solving skills with an ability to influence internal stakeholders as well as external industry and health authorities
- Ability to lead a team, create a positive work environment and effectively develop staff
-
Associate Director
2 days ago
AstraZeneca Gaithersburg, United States**Associate Director (Integrated Bioanalysis)** · **Bold Disruptors. Push the boundaries of science. Fearlessly break new ground.** · Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We're looking for dynamic thou ...
-
Associate Director, Enablement
1 week ago
AstraZeneca Gaithersburg, United States**Associate Director, Enablement & Data Insights** · **Location: Gaithersburg, MD or Barcelona, Spain** · **Introduction to role**: · Are you ready to make a bigger impact? Join AstraZeneca, an ambitious company that's on a mission to do more and be more. As an Associate Director ...
-
Associate Director, Brand Communications
1 week ago
AstraZeneca Gaithersburg, United StatesAstraZeneca is leading a revolution in oncology to redefine cancer care. We have a bold ambition to one day eliminate cancer as a cause of death. We are looking for an Associate Director of Brand Communications to join us as a core member of the US Oncology Corporate Affairs team ...
-
Associate Director Integrated Bioanalysis
1 week ago
AstraZeneca Gaithersburg, United StatesAt AstraZeneca, we win through science, it's at the heart of our every success. That science is only possible when we all work together - we'll always make sure you're clear about how your role is connected to our wider mission to really show what science can do · We are seeking ...
-
Associate Director Integrated Bioanalysis
1 week ago
AstraZeneca Gaithersburg, United States**Associate Director Integrated Bioanalysis -Oncology Bioanalytical Strategy Lead** · **Locations - Gaithersburg, MD** · **Comprehensive salary and benefits package** · **Introduction to Role**: · Are you ready to make a significant impact in the world of bioanalysis? As part of ...
-
Associate Director- Molecular Specialist
1 week ago
AstraZeneca Gaithersburg, United States**Bold Disruptors. Push the boundaries of science. Fearlessly break new ground.** · Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We're looking for dynamic thought leaders with curious minds, who are comfortabl ...
-
AstraZeneca Gaithersburg, United States**Associate Director Clinical Pharmacology and Pharmacometrics (Clinical Pharmacology)** · Introduction to Role: · Are you ready to make a meaningful impact on patients' lives? We are looking for an Associate Director Clinical Pharmacology to join our dedicated Research & Develop ...
-
Associate Director, Patient Safety Scientist
2 weeks ago
AstraZeneca Gaithersburg, United StatesAssociate Director, Patient Safety Scientist · Location: Onsite 3 days in Gaithersburg · This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scient ...
-
Associate Director, Sox Compliance
4 days ago
Novavax Gaithersburg, United StatesIf you find science, speed, and success exhilarating, you have come to the right place. · Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of ...
-
Associate Director, Oncology Portfolio Contract
3 weeks ago
AstraZeneca Gaithersburg, United StatesAt AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and partnering with colleagues and customers to make the seemingly impossible a reality. We're passionate about the potential of science to address the unmet needs o ...
-
Associate Director, Cmc Regulatory Affairs
3 weeks ago
AstraZeneca Gaithersburg, United StatesThe role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and sophisticated product ranges from the development phase through to global launch and post-approval lifecycle management. Role holder w ...
-
Associate Director, Validation
1 week ago
AstraZeneca Rockville, United States**What you'll do**: · - Own and maintain a robust qualification and quality program to support and maintain a qualified and compliant state facility, including processes, laboratories, and utility equipment. · - Support Computerized System Validation (CSV) documents including Ris ...
-
Associate Director, Facilities
2 days ago
Regenxbio Rockville, United States**The Opportunity** · As the Associate Director, Facilities, you will be responsible for managing the design, planning, construction and maintenance of equipment, machinery, buildings and other facilities. In this role, you would plan, budget, and schedule facility modifications, ...
-
Associate Director, Msat
3 days ago
GSK Rockville, United States**Site Name**: USA - Maryland - Rockville · **Posted Date**: Apr · Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical product development? If so, this Biopharmaceuticals Manager role could be an ideal oppor ...
-
Associate Director of Validation Consultant
2 weeks ago
The Verity Collective Rockville, United StatesJob Overview: · We are seeking a highly skilled Associate Director of Validation (10+ years experience) to join our team as a consultant for a 6-9 month on-site Contract in Rockville, MD. · 1. Review and enhance Validation Master Plan to include comprehensive facility and equipme ...
-
Cmc Ra Associate Director Project Leadership
2 days ago
AstraZeneca Gaithersburg, United States**CMC RA Associate Director Project Leadership** · Are you ready to turn our pipeline into reality and impact unmet patient needs? We are seeking a CMC RA Associate Director Project Leadership to join our Oncology R&D team. The role holder will have the appropriate level of CMC R ...
-
Otsuka Rockville, United StatesOtsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to mee ...
-
Associate Director, Supply Chain Operations
1 week ago
Arcellx Rockville, United States**Who We Are** · Arcellx is** **a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and o ...
-
US Department of Energy - Agency Wide Germantown, United States**Duties**: · The Department of Energy's (DOE) Office of Science - Headquarters is looking for a dynamic, innovative, seasoned executive to lead the Basic Energy Sciences (BES) program-one of the nation's largest sponsors of research in the natural sciences, and it is uniquely re ...
-
Associate Director/director
1 week ago
US Millennium Challenge Corporation Washington, United States**Duties**: · - Directs and performs a variety of assignments associated with the management and oversight of the design, development, and implementation of infrastructure programs and projects in MCC Compacts. · - Prepares plans for Compact infrastructure programs and projects i ...
Associate Director - Gaithersburg, United States - AstraZeneca PLC
Description
Associate Director (Human Factors Engineering)Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Summary of the group:
The Human Factors Engineering Group provides human factors (HF) expertise and leads human factors engineering (HFE) work on device development project teams developing drug delivery systems.
The Human Factors Engineer may support more senior Human Factors Engineers, and/or directly collaborate with cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to develop drug device combination products and ensure these products are safe and effective for use.
About the role:
The successful candidate will be a strong voice of user/patient centricity across AstraZeneca. This candidate will be a leader in the human factors engineering group.
They will build strong relationships and collaborate with cross-functional leaders in development, regulatory, quality, clinical, commercial, and operations, to guide development of combination products and ensure these products are safe and effective for use.
Main Duties & Responsibilities:
Education & Experience Requirements:
Education:
Bachelor's or Master's Degree in human factors engineering, bioengineering, mechanical engineering, or related field
Experience:
Bachelor's Degree and 15+ years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development -OR- Master's Degree and 12+ years of related experience with at least 7 years of experience in applying human factors engineering to medical device or combination product development.
Required Skills:
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big.
Join us on our journey of building a new kind of organization to reset expectations of what a biopharmaceutical company can be.
This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines.
Date Posted
18-Apr-2024
Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.