Job title: Staff Analyst, Clinical Research
Job description: Who we want:
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Persuasive influencers. People who understand market positioning and can use their relationship skills and depth of knowledge to secure buy-in, cooperation, and loyalty.
- Hard-working winners. Confident, competitive and results-oriented salespeople who create a track record of success.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues
What you will do:
- Drive the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle and fostering alignment with adjacent complex processes (Marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy).
- Designing compliant and sustainable literature search strategies, and performing complex literature queries to retrieve published clinical data,
- Identifying, appraising, and analyzing all relevant (clinical, PMS, marketing, and testing data) from multiple sources and formats and create a comprehensive scientific review, including in depth statistical analyses, risk management cross-check and descriptive analyses, following complex and rigorous methodologies.
- Analyzing the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.
- Based on a detailed and up-to-date understanding of US, European and Australian regulatory requirements, and expectations, elaborate, and defend, with the Medical Expert, a conclusion on the overall risk-benefit statement.
- Identify unanswered questions and residual risks in the Clinical Evidence, and design Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.
- Defining and developing Clinical Evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.
- Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence with the Medical Experts, helping to define, plan, and initiate clinical studies and in vitro tests together with all stakeholders from Clinical Research, R&D, Biomechanics and Regulatory.
What you need:
- Education: University degree (PhD, Master’s or equivalent) in a field related to the life sciences or a relevant medical engineering field (biology, physiology, biomaterials, biomedical engineering or similar).
- Experience: 5 to 10 years of experience in Scientific or Medical Writing, and/or relevant academic or clinical research experience (PhD, Post-doc)
- Experience in clinical or regulatory affairs preferred
- Experience with orthopedic or trauma devices preferred
Work From Home: Occasional
Travel Percentage: 10%
Location: Gurgaon, Haryana
Job date: Wed, 16 Jun 2021 00:37:48 GMT
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