Company Profile:

Stryker is one of the world’s leading medical technology companies and together with our customers we are driven to make healthcare better We offer innovative products and services in Medical and Surgical Neurotechnology Orthopaedics and Spine that help improve patient and hospital outcomes

Job description:

Who we want

• Medical Device Understanding. Solid understanding of medical device technology, including familiarity with various device classes, applications, and relevant regulatory requirements.
  • Proficiency in scientific literature databases and search tools (e.g., PubMed, Embase) to efficiently retrieve and manage relevant publications.
  • Effective Communicators Strong written and verbal communication skills, including the ability to summarize scientific information in a clear and concise manner.
  • Analytical Thinker Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. Excellent analytical and critical thinking skills, with the ability to extract and interpret complex scientific data. Attention to detail and ability to work independently and within a team, managing multiple projects simultaneously.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • 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. 
  • People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams. Knowledge of regulatory requirements and standards relevant to medical devices (e.g., FDA regulations, ISO 13485) is a plus.
  • Prior experience in the medical device industry, clinical research, or related fields is highly desirable.

If you are passionate about scientific research, possess strong literature analysis skills, and have a keen interest in the field of medical devices, we would love to hear from you. Join our team and contribute to improving patient outcomes through the advancement of innovative medical technologies.

What you will do

As the Literature Scientist, you will support the SGTC Clinical Affairs function deliverables with through the processing of scientific data. You will work with confidential company data and you will interface with cross-functional internal and external stakeholders.

Key Result Areas -

• Conduct comprehensive literature reviews to identify relevant scientific publications, clinical studies, and regulatory guidelines pertinent to our medical devices and succinctly summarize scientific content for assigned projects in given timelines
• Utilize scientific methodology and tools to identify and appraise information from scientific literature databases.
• Propose and participate in departmental continuous improvement initiatives. 
• Analyze and synthesize research findings to extract key insights, trends, and knowledge gaps related to our products and their therapeutic areas.
• Collaborate with cross-functional teams, including R&D, regulatory affairs, clinical affairs, and product management, to gather information and align literature review objectives with business needs.
• Participate in post-market surveillance activities by conducting routine systematic literature reviews (e.g., screen articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.

Support Areas

• Assist in the development of internal procedures, templates and style guides.
• Provide subject matter expertise and consultation to Clinical Research Associates, Biostatistics, Data Management, Regulatory Affairs, Clinical Safety and other internal and external stakeholders.
• Stay up-to-date with the latest advancements and scientific literature in the field of medical devices, ensuring that our organization remains well-informed and at the forefront of industry developments.
• Provide critical analysis and interpretation of scientific data to support decision-making processes, product development strategies, and regulatory submissions.
• Assist in the preparation of scientific manuscripts, conference abstracts, and other scientific communications, ensuring accuracy, clarity, and adherence to established guidelines.
• Contribute to the development of internal literature databases, ensuring efficient storage, retrieval, and organization of scientific references.
• Collaborate with external partners, such as academic institutions and key opinion leaders, to foster scientific collaborations, identify potential research opportunities, and facilitate knowledge exchange.
• Maintain compliance with relevant regulations, standards, and quality management systems applicable to medical device literature research.

What you need

• Education –
  • MD or DNB or Master of Surgery (preferably Anatomy, community medicine, internal Medicine, Neurology or similar) with 0-2 years of experience

OR

• Medical Graduate (MBBS or BHMS) or PhD with allied health sciences, with 3 – 5 years of experience

OR

• Allied paramedical (Nursing, Physiotherapy, pharmacy or biotechnology, biomedical engineering) post graduate degree with 5-7 years of experience

OR

• Other post graduate degree in allied health sciences with 7-8 years experience
• Experience –
  • Experience in writing Literature search protocols, literature summaries, clinical study excerpts, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses, literature summaries required.
  • Experience in IDE / Class III products/ clinical trials preferred.
• Software and platforms
  • MS office, MS word
  • PubMed, Distiller, Google Scholar, Proquest, Cochraine, EMBASE etc.
• Excellent working knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/ MDCG) and quality standards (ISO14971, ISO 13485, ISO 14155 guidelines is preferred.