Intern: Medical Writer

3 weeks ago

Bengaluru, India Stryker Full time

**Why join Stryker?**:
Our total rewards package offering includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

**Know someone at Stryker?**:
The Intern: Medical Affair acts as the technical expert in driving this highly complex and demanding process. He/she applies scientific, regulatory and project management skills to establish the evaluation strategy and to compile the body of Clinical Evidence, allowing, in collaboration with the Medical Expert, to reach a legally binding scientific conclusion on the safety and performance of devices in patients, throughout the product lifecycle.

The Clinical Evaluation Specialist bears the operational and regulatory responsibility of individual clinical evaluation reports and may defend them in audit situations.

Tasks include
- Driving 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.

**About Stryker**:
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

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