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Basic qualifications:
- Bachelors degree
- Prior experience of leading the development, review or management of cross functional or above country written standards or projects
- Prior experience of developing positions and engaging external stakeholders on R&D issues.
- Experience in managing the navigation of decisions and/or execution through multiple parties in matrix teams/ organisations.
Preferred qualifications:
- Bioscience degree, and experience in the conduct and disclosure of clinical trials
Details:
Summary ...
Accountable for external engagement on clinical study transparency and the development and review of medical governance written standards on the conduct and disclosure of clinical research so these documents reflect GSK values, regulatory and legal expectations and are also succinct, clear, aligned and readily accessible across the medical organisation.
Key Responsibilities ...
When necessary Develop external GSK positions and represent GSK positions at external meetings (eg Trade Association meetings) with a particular focus on data transparency.
Work with Communications, R&D Policy and Government Affairs to co-ordinate external engagement on clinical study transparency and support senior management.
Development and maintenance of content expertise related to conduct and disclosure of clinical research including external developments that impact or are likely to impact on these areas.
Leadership of global, cross functional and Business Unit teams to develop end-to-end process maps and develop, revise and enhance the quality of written standards in these areas to ensure they are fit for purpose and accessible
Engage GSK staff from all parts of the GSK company to develop effective and fit for purpose end-to-end processes, written standards and external positions.
Authorship of key written standards in these areas.
Point of contact to provide explanations and clarifications related to written standards for the conduct and disclosure of clinical research
Make recommendations for approval of final drafts prior to Chief Medical Officer or Medical Governance Topic Board chairs for endorsement or approval.
Work with medical governance, compliance and other relevant functions to ensure effective implementation of GSK policy in the conduct and disclosure of clinical research
You will work with the Medical Policy team to ...
- Establish and maintain a robust process for the development and review of written standards for medical governance.
- Develop and oversee a plan to revise all written standards in their areas of expertise reducing the number of written standards and complexity of the medical policy framework at GSK.
Basic Requirements ...
Bachelors degree, and experience of one topic under medical governance with preference for ethical conduct of clinical trials and clinical study transparency (Ethical conduct of clinical trials, safety reporting and evaluation, scientific engagement, medical information, Code of Practice for Promotion and customer interactions).
Prior experience of leading the development, review or management of cross functional or above country written standards or projects
Prior experience of developing positions and engaging external stakeholders on R&D issues.
Experience in managing the navigation of decisions and/or execution through multiple parties in matrix teams/ organisations.
*** Competitive Salary ***
Closing date for applications: 7th Nov 2016
When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.
Thank you for your interest in this opportunity.
If requiring an adjustment for a disability, once selected for interview you may contact ukdiversity.recruitment@gsk.com
Contact information:
You may apply for this position online by selecting the Apply now button.
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