Job Description Summary

As a Medical Writer you will be responsible for the evaluation of clinical data and the writing/ creation of clinical and scientific reports. These documents are used in regulatory submissions to support safety and performance of our products, to help define clinical endpoints for New Product Development teams, and to aid in the identification of new indications and unmet needs. This role will support the BD Interventional Surgery Business Unit within the Clinical Affairs Function. This individual will report to the Manager, Medical Writing within this team.

Job Description

Job Responsibilities:

• Prepares, writes, and revises clinical documents pertaining to global regulatory submissions, and associated communications with the regulatory authorities (e.g., Notified Bodies) to support business needs. Key documents include Clinical Evaluation Plans and Reports (CEP/ CERs) and related documents for all BDI Surgery products.
• Conducts literature searches and participates in systematic literature reviews for clinical evaluation and various other business needs (e.g., state of the art review, derivation of safety & performance outcomes, post market surveillance reports).
• Critically analyzes and summarizes clinical data (e.g., literature, real world data, clinical trials, etc.) for accurate presentation in assigned documents (e.g., CERs).
• Works with cross functional teams including but not limited to Product Development, Regulatory Affairs, Post Market Surveillance, Quality, and Marketing to complete the above project types.
• Ensures documents are produced in accordance with corporate/ BU procedures, and regulatory standard/guidance.
• Completes all training as assigned and relevant trainings for scope of work. Learns and applies team best practices.

Education and Experience:

• Bachelor’s Degree in the sciences with 2–4 years of experience in medical writing for medical devices (preferred) or related industry. Advanced degree in a scientific subject area a plus (e.g., PhD, MPH/MSPH).
• Experience writing Clinical Evaluation Reports (CERs) beginning to end is required.
• Experience preparing documents for high risk (Class II and Class III) medical devices.

Knowledge and Skills:

• Ability to research and write with scientific accuracy and present information clearly in one’s own words.
• Understanding of systematic literature reviews. Skilled at conducting literature searches using PubMed, Embase, Ovid, or other similar medical literature databases. Prior usage of DistillerSR a plus.
• Knowledge of scientific or clinical research/ methods, device development processes, regulatory requirements, good clinical and data management practices.
• Knowledge of EU MDR, MEDDEV 2.7/1 Rev 4, MDCG, and IMDRF and their role in clinical evaluation required.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Excellent English Language skills, especially in writing and proof reading. Strong oral and written communication skills.
• Able to handle and complete a variety of projects at the same time, and to support other team projects as needed. Able to meet project goals within a matrixed environment.

Work Environment:

• Remote
• Ability to travel up to 10%.

Required Skills

Optional Skills

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Primary Work Location

IND Gurgaon - Aurbis Summit

Additional Locations

Work Shift