5+

Develop, strategize and plan business activities like portfolio selection, brand planning and launch, KOL management, compliance and other crucial activities in therapy and additional therapeutic areas. This is towards assimilation of scientific and medical know-how in aligning activities to meet the business goal of the concerned therapeutic areas, business unit. Understand on ground clinical practices by interacting with clinicians, to develop practical knowledge and utilize it to provide closer-to-market product solutions

As a Principal Medical Writer you will play a pivotal role in leading the Medical Writing efforts for Marketed Products and Lifecycle Management, both globally and at regional, local levels. You will represent the department as a subject-matter expert on clinical study teams, leading document-related meetings and reviewing study-related documents.

Contamination Control, Isolator handling, Environmental monitoring. Disinfectant studies, Rapid microbiology analysis.

M.Sc / B.Pharm / M.Pharm. Material Dispensing, Ointment, Gel Manufacturing, Filling, Packing, Track and Trace, Labelling, Cartonator, QMS. IPQA, Document Cell, OOS, OOT, Process/ Cleaning Validation, Review of BMR & BPR, Training ,QMS Investigation, CAPA, SOPs etc.

He, she participates in all activities relating to preparation, submission and follow up to obtain approvals, renewals for products and its variations and line extension indications and labeling approvals of medical devices of various business units of Medtronic. He, she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures

Supervision of aseptic area activities, shift handling, aseptic area documentation, media fill activities, aseptic behaviour monitoring, and sterile operations. Handling area cleaning and sanitation activities, supervising steam sterilizer loads, filter integrity, disinfectant preparation and filtration activity, and related documents.

Use technical knowledge to perform in-depth review of API drug master file as per current US FDA expectations; identify deficiencies and formulate strategies to resolve them. Close coordination with Packaging material and Excipient vendors, placing orders, arranging technical documents to Analytical and Regulatory teams.

Design, plan and perform scientific experiments for projects at different clinical phases of drug substance and drug product with minimal guidance. Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.