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                  Medical Director- SERM

                  GlaxoSmithKline
                  Collegeville, PA 19426
                  Full-time, Part-time
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                  Job Description

                  • Collegeville, Pennsylvania; Research Triangle Park, North Carolina
                  • Medical and Clinical
                  • 251828

                  Are you energised by the opportunity to work with global stakeholders to design, deliver and embed critical highly visible safety programs that have a global impact? If so, this role could be an ideal opportunity to explore. As a Medical Director in the Safety Evaluation and Risk Management group, you will play a key role in supporting the Central Safety Leadership Team, and the broader business at both a strategic and operational level.

                  This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following -

                  • Deliver strategic solutions and lead the implementation for key organizational/process changes ensuring that GSK can comply with pharmacovigilance regulations worldwide

                  • Develop strategy and lead the implementation of core business activities (e.g. Communications, Information Management, Training), seeking endorsement from the Central Safety Leadership team; provide ongoing, thoughtful programme management and change management support to ensure delivery against a strategic agenda

                  • Lead the review and re-design of critical business processes; deliver solutions that align across business units; develop and lead training / change management activities

                  • Provide specific subject matter expertise on relevant business processes to ensure regulatory compliance and appropriate management of risk across GSK (to include authoring process documents, adhering with evolving regulatory requirements, delivery of training and the proactive identification of potential compliance risks)

                  • Secretariat to Central Safety governance boards/leadership teams as appropriate; ensure appropriate/timely agendas/minutes (to include action tracking) based on input from stakeholders; provision of appropriate project management leadership

                  • Project management support for the business change initiatives/process updates to include driving the development and tracking of business plans (including objective setting, Key performance Indicators, benefits tracking)

                  • Line manage scientific/technical associate staff who support specific business activities including provision of metrics, information management, communication and website related deliverable (as needed)

                  Why you?

                  Basic Qualifications:

                  We are looking for professionals with these required skills to achieve our goals:

                  • Medical De gree
                  • Expert evaluation skills and analytical thinking
                  • Outstanding medical writing skills
                  • Sound computing skills
                  • Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
                  • Expertise in causality assessment, ev aluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education.
                  • Likely to be recognised as an authority in this area at high levels within GSK outside of GCSP and also possibly in the external international pharmacovigilance arena
                  • In depth knowledge of the therapeutic area of assigned GSK products
                  • In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at t he population level
                  • In depth knowledge of medical and drug terminology and a sound foundation in pharmacology. Good medical judgement and ability to make medical decisions
                  • In depth knowledge of clinical development proces s
                  • In depth understanding of drug a pproval process in major countries

                  Preferred Qualifications:

                  If you have the following characteristics, it would be a plus:

                  • Advanced Degree Life Sciences or Pharmacovigilance

                  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:

                  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk

                  • Managing individual and team performance.

                  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

                  • Implementing change initiatives and leading change.

                  • Sustaining energy and well-being, building resilience in teams.

                  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

                  • Developing people and building a talent pipeline.

                  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

                  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

                  • Budgeting and forecasting, commercial and financial acumen.

                  This is a job description to aide in the job posting, but does not include all job evaluation details.

                  *LI-GSK

                  If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

                  GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

                  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.

                  Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

                  If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

                  GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

                  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.

                  Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

                  Full-Time, Collegeville, Pennsylvania, United States

                  Medical Director, SERM

                  Full-Time, Collegeville, Pennsylvania, United States

                  Start a career with purpose

                  GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer.

                  Annual bonus based on company performance

                  Long term incentives and pension plan

                  Learning and career development

                  Access to healthcare & wellbeing programmes

                  Posting ID: 564763607Posted: 2020-08-09