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As a key partner to the GM, the incumbent will lead the Spain/Portugal Medical Affairs department and be positioned as the Medical lead to both internal and external audiences. The...
To ensure the implementation and regulations for the registration, certification, pricing and reimbursement and marketing of products; To define the strategy and planning of...
Overall responsibility of the handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in...
The Safety Manager is part of the Project Delivery organization and is responsible for management in post-marketing drug safety and will work according to company policies, SOPs...
Regulatory strategy planning. Regulatory compliance verification for the products (GLP, GMP; gap analysis). Preparation of response documents to the deficiency letters of health...
Overall responsibility of the handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in...
Assists in developing, implementing, and analyzing work within a specific or broad area of site start-up, such as site activation, regulatory/ethics submissions, site contracts,...
Accountable for all activities of site related study execution of assigned studies/Monitors involving start-up, execution, and close-out. Accountable for the on-time and within...
Provide QA oversight of the Medical Device/Combination Products including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed in-house and in...
Leadership and management of the local Pharmacovigilance Team; Ensuring that Quality System/Standard Operating Procedures are in place; Acting as the key Affiliate contact for both...
Implement the Medical Devices Business Development Strategy; Coordinate all activities related to medical devices, regulations, quality and vigilance; Expertise in regulatory files...
Accountable for overall management of CTM and identify training needs of the group, support career development and proactively manage performance issues; Develop and maintain CTM...