Job title: Manager-CTA/IND Development Delivery
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Site Name: India – Maharashtra – Worli Mumbai, Bengaluru Luxor North Tower Posted Date: Jan 25 2022 Job Purpose: Manages team and will be responsible for workload assessment and allocation of resource within R&D investigational pro
Job Description : Site Name: India – Maharashtra – Worli Mumbai, Bengaluru Luxor North Tower Posted Date: Jan 25 2022 Job Purpose: Manages team and will be responsible for workload assessment and allocation of resource within R&D investigational products for CTA/IND team and also ensure that appropriate content for specific submissions are supported for all R&D projects Effective line management & mentoring of the assigned resource to ensure that appropriate content is delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role. Job holder will also be a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department Key Responsibilities: Manage HR aspects for a team of direct reports including recruitment, training and development Manage and take accountability of workload within assigned team and work with functional lead to address resource challenges Proficient knowledge of Clinical Trial Directive, DIA TMF Reference Model and CTA/IND submission requirements for multiple countries/submission types Have good knowledge in processes, ways of working and current EU/EMAP/US guidelines for CTA/IND, and use this expertise to provide training, consultation and solutions within the team/ department as well as externally outside the department Manage and accountable for the work of CTA/IND submission coordinators Accountable to the development delivery functional lead for overall allocation of work plans, manage GRLs/TGs for overall CTA/IND study service request & allocation for agreed tasks and projects Ensures quality of both own and team submission and compliance with regulatory guidelines and process as they apply to the role. Provides consultation and solutions being a subject matter expert in processes. Lead the creation and implementation of CTA/IND submission coordinator working practices and procedures aimed at simplifying processes and maintaining quality. Managing of development, refinement of the CTA/IND lifecycle strategy, timely content & delivery appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures. Works with staff from other functions and should be capable of working to senior levels in development functions in provision of advice, interpretation of relevant guidance’s, researching topics and resolving issues. Required to liaise with LOC and Regulatory Agencies to resolve issues in relation to their accountabilities Support submission team review and approval procedures Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format Check compliance of others’ work with requirements and standards Generate appropriate metrics and key performance indicators for the team, and use metrics to develop and enhance capability within the GRC Basic Qualifications: Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Preferred Qualifications: Masters degree or higher in biological or healthcare science Minimum Level of Job-Related Experience Required: 7-9 years of Global-CTA/IND submission experience & Knowledge of regulatory agency guidelines Managed an operational/production team of more than 5 people that successfully delivered outputs to time and quality over period of 2years Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives. Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations for both Investigational and Licensed Products Successful and sustained delivery of a significant number of submission packages including a broad range of submission types. Relevant Job skill or Abilities required for the job: Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way. Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers Service-oriented , customer focused ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Ability to build effective working relationships and work in a matrix environment effectively Ability to think flexibly in order to meet constantly shifting priorities and timelines. Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way. Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers Excellent written and verbal communication skills and ability to present information in a clear and concise manner Ability to define and implement new processes and quality initiatives with an awareness of relevant controls and impacts. Highly developed interpersonal, presentation and communication skills with established internal and external networks. Ability to work carefully under time constraints *LI-GSK Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. 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Location: Mumbai, Maharashtra
Job date: Thu, 27 Jan 2022 23:19:28 GMT
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