Scientific Writer

Job description

·  Bengaluru, India
·  Quality Management
·  120476
Siemens Healthineers

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Job Description

Position Summary:

The Diagnostic Imaging Division of Siemens Healthineers is looking for a Scientific Writer for our Bangalore location.

The Scientific Writer is a member of the Clinical Affairs team. He/She will collaborate with a cross functional project team to conduct clinical evaluations and participate during the project life cycle for assessment of clinical benefit-risks. This position is responsible for the development of Clinical Evaluation Reports (CERs) for the various products.

Responsibilities

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Provides writing and peer review support throughout the development and publishing of clinical evaluation reports compliant to applicable regulatory requirements.

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Communicate new risk identified during clinical evaluation with marketing, product managers and regulatory teams.

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Critically appraise scientific literature and write clinical summaries for products.

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Data fact check and peer review of the literature summaries and CER sections.

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Coordinating the efforts of team members in order to deliver projects according to plan.

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Attention to detail and accuracy in capturing/reviewing clinical data

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Work on cross functional teams with strong communication, presentation & interpersonal skills

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Analytical thinking skills with strong demonstration of scientific writing and verbal communication

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Conduct proofreading, editing, document formatting, review comment integration and document completion

Education and Knowledge

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Medical degree/MS in Health sciences related degree with 3+ years of experience in clinical and/or regulatory affairs or BS/BA with 5+ years related experience; preferably in a highly regulated medical solutions industry.

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Demonstrated problem solving capability and results orientation.

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Experience in research methodology, scientific literature review (PUBMED, EMBASE, MEDLINE etc.) and medical writing.

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Expertise in systematic literature searches for safety, performance and state of the art, literature review and appraisal of clinical data.

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Experience of FDA (21 CFR 212, 21 CFR 820 etc.), EU (MDR, MDD, MEDDEV 2.7/1), ISO 14155/GCP and other regulatory standards.

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Experience in marketing / clinical claims management and mapping clinical evidence to marketing/clinical claims.

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Strong critical/analytical thinking and problem-solving skills.

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Excellent interpersonal, written / verbal communication and presentation skills.

Preferred:

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Knowledge in the therapeutic area – specifically in the field of diagnostic radiology, interventional radiology and radiation oncology

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Experience with regulatory submissions for EU Class IIb Medical devices.

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Advanced degree (MD, PharmD, PhD etc.) and/or experience in radiology, cardiology or medical imaging.

Job ID: 120476

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Mid-level Professional

Job Type: Full-time

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