Manager, Clinical Transparency Reporting

Manager, Clinical Transparency Reporting

GlaxoSmithKline Pte Ltd
8-11 years
Not Specified

Job Description


Job Description :
Site Name: Bengaluru Luxor North Tower Posted Date: Jul 7 2021 Would you like to enhance your clinical systems expertise with an opportunity to accelerate compliance and efficiency across clinical operations If so, this Clinical Support Manager role could be an excellent opportunity to explore. Lead large scale Disclosure projects To be a point of contact for the Regulatory groups to ensure changes in the regulations impacting clinical are brought to the attention of relevant Practice/Function heads and included in GSK processes and documentation. To be on point to collect feedback from the clinical groups for any regulatory consultation. Sponsor process and/or system changes that will simplify the regulatory process, improve compliance, and support new regulatory requirements. Provide updates on changes to the regulatory process, feedback and metrics to Regulatory Affairs and the major stakeholders Be part of the Governance model for the processes/systems when required Proactively identify potential process problems/issues and develop/negotiate recommendations for resolution. Be appropriately assertive and confident to be able to engage in the area of acquired expertise with staff at all levels across the business. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: The role requires the incumbent to build cooperative and collaborative relationships within a matrix environment across various groups within and external to GSK, including, but not limited to Reg affairs, IT, CCSE, Business Units, MDCs, CPSSO, LOCs, Biologics and Consumer Healthcare . Scope of support includes all phases and all areas of the business CCSE, MDCs, IUs, CEDD/DPU, CIC, CUC. The incumbent maintains a high level of awareness of the changing external regulatory environment and partner with Regulatory Policy and Change personnel, External Affairs directors in R&D etc Significantly contribute to operational strategy to meet regulatory and policy driven disclosure requirements Key collaborator in clinical processes surrounding IND/NDA Annual reporting and Financial Disclosure Reporting Works with Director on GSK strategy around disclosure and transparency Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree in Life Sciences or related discipline postgraduate degree preferred- a minimum 8 years clinical development experience Proven leadership ability either directly or in the matrix In depth understanding of R&D and the clinical development process Experience in a regulatory requirements is an advantage Ablity to present at high level management teams Good team-working skills with ability to work with a high degree of independence Demonstrable ability to provide first rate customer service Ability to effectively manage conflicting demands in a high pressure, constantly changing environment Excellent verbal and written communication skills Experience of providing informal or formal support to a diverse user community Knowledge/awareness of GSK systems impacting the regulatory processes Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning.. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. GSKIndia_RD *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. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. 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