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Sr. Associate I, Product Complaints Cambridge United States,
Posted on : 10 July 2017
- Supervisor-level individual contributor role providing subject matter expertise and independent representation/responsibility in the US Technical Product Complaints (TPC) team as it pertains to product-related consumer complaints and post-market surveillance, ensuring compliance with regulatory standards for the markets in which the company s products are manufactured or distributed.
Key responsibilities of the Senior Associate I, Product Complaints include:
- Conduct product complaint investigations as well as review cases.
- Engage and partner with peer/stakeholders groups including but not limited to INTL TPC, Patient Services, SABR, External Manufacturing, Technical Development and IT on continuous improvements, investigations/troubleshooting, and operational/productivity matters.
- Autonomous support to Post-Market Surveillance (PMS) activities, including leading product-based PMS teams, authoring/coordinating annual PMS reports, and contributing to improvement/expansion initiatives.
- Provide and analyze/interpret aggregate product complaint data, and report/present findings succinctly.
- Author Product Complaint sections for Annual Product Review (APR) reports.
- Provide ad-hoc TPC support for regulatory inspections and compliance audits.
- Provide ad-hoc TPC support for lab operations/maintenance.
- Minimum of five (5) years of Product Complaints or related experience, with 8+ years of biotech/pharmaceutical industry experience.
- Strong abilities in conducting investigations and root cause analyses.
- Comfortable with applying and interpreting statistics.
- Proficient at data mining and producing/reporting metrics and analytics.
- Strong verbal and written communication skills.
- Strong interpersonal and relationship management skills.
- Strong project management ability.
- Practical knowledge with TrackWise (operation and infrastructure).
- Working knowledge of Word, Excel and PowerPoint.
- Familiarity with GXPs and Quality Management Systems.
- Familiarity with FDA, EMA and ISO regulations.
- Other critical skills include: solid organizational skills, effective technical writing and communication skills, ability to work cross-functionally with teams with appropriate attention to detail, comfortable driving for results while dealing with subjectivity and ambiguity, and demonstrated ability to lead/represent/work autonomously.
Bachelor's Degree in Science (e.g., Biology, Chemistry, Biochemistry, Chemical/Biochemical Engineering, or related disciplines) with equivalent experience.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer s disease, Parkinson s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer s disease, Parkinson s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
Job Segment: Biochemistry, Biotech, Chemical Research, Engineer, Quality Manager, Science, Engineering, Quality
Cambridge MA US
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