Job ID 79742BR
Position Title Human Factors Engineer - Parenteral & Topical
Division Pharma
Business Unit Pharma - Global Development
Country Switzerland
Work Location Basel
Company/Legal Entity Switzerland Novartis Pharma AG, Basel
Functional Area Development & Medical
Job Type Full Time
Employment Type Permanent
Job Description To support our rapidly growing product pipeline, we
are looking for a candidate with strong expertise in human factors
engineering for drug delivery devices, with demonstrated ability to
successfully lead human factors activities within device development projects.
This position is a key strategic role in the Novartis device
development process and the successful candidate will plan and
implement a compliant research program into device development
projects and will aid in supporting registration with Health
Authorities on human factors issues. The role will include
responsibility for the full range of human factors tasks in
developing a device ranging from working with marketing in developing
requirements specifications, formative and summative studies
including late stage validation and post-market surveillance studies.
This typically includes writing study protocols and reports for Heath
Authority submission in compliance to prevailing human factors
regulations and standards.
The role requires good stakeholder management skills as it will
involve extensive communication between different areas of the
company including the commercial business franchises, marketing, drug
regulatory affairs (DRA). The role will also include extensive
outsourcing project management, including managing budgets,
conducting quality audits to qualify new suppliers, implementing
procurement strategy and managing a range of external suppliers.
You will be working in a communicative & dynamic environment with a
flat organization, where creativity and self management are important
skills. The position offers opportunities to work in
multidisciplinary and international teams, across projects, where
your specific contribution within human factors engineering is a key
element for success. Management of external partners is also an
important part of the role.
The successful candidate will be responsible for independently
leading the planning, execution and reporting of human factor
studies, according to current regulations and guidelines within the
pharmaceutical and medical device industry.
Minimum requirements Education Relevant degree level.
Languages: Good knowledge of English (verbal and written)
Desirable knowledge of German (verbal)
Experience/Professional requirement: 1. Several years experience in
human factors engineering for medical devices and/or pharmaceutical
packaging, including general understanding of design controls and
quality systems requirements.
2. Thorough knowledge of human factors regulations and guidelines for
medical devices and pharmaceutical packaging.
3. Experience in design of formative and summative human factor
studies at requirements, design testing, verification and validation
stages of device development.
4. Experience in writing human factors engineering protocols and
reports as support for registration documentation.
5. Excellent leadership and project management skills as well as
experience in management of external partners.
6. Experience in management of internal stakeholders.
7. Excellent presentation and scientific writing skills.
8. Basic knowledge in statistics is beneficial.
9. Knowledge and experience in the application of risk management to
medical devices is beneficial.
To apply:
<
http://www.novartis.com/careers/job-search/index.shtml>
http://www.novartis.com/careers/job-search/index.shtml,
search for Job ID 79742.
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Received on 2011-04-04 12:14:24