Is This A Late April Fools Joke Or What?…


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Ethics & Compliance Officer at GlaxoSmithKline (GSK)

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GlaxoSmithKline (GSK), one of the world’s leading research based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GSK employs over 97,000 employees in over 100 countries worldwide.GlaxoSmithKline Consumer Nigeria Plc is one of Africa’s largest consumer healthcare companies, producing leading brands such as Lucozade, Ribena and Panadol.

We are recruiting to fill the position below:

Job Title: Ethics & Compliance Officer

Requisition ID: WD205739
Location: Lagos

Position: Full time

Functional area: Governance, Ethics and Assurance

Job Purpose

  • Through the successful implementation of GSK Internal Control Framework and compliance programs, this role will support Global Ethics and Compliance (GEC) strategy to ensure that the right product gets to the right patient or consumer in the right way.
  • This role moreover supports GSK’s mission to help people do more, feel better and live longer.

Specifically, the Nigeria Country Ethics & Compliance Officer will:

  • Ensuring effective compliance oversight of the Nigerian Rx business, focusing on the Commercial business, but also bridging across other support functions including Regulatory, Quality, Medical, Supply Chain, Procurement, IT, Finance, etc., supporting the establishment of strong internal controls
  • Supporting the Nigeria General Manager of Rx to ensure compliant processes and solutions working with GEC and Business Unit leadership teams;
  • Promoting a value based compliance culture through engagement communication and training initiatives;
  • Supporting early and proactive identification and management of risks aligning with GSK’s Risk Management process

Key Responsibilities

  • Working with GSK Pharma senior leaders across designated departments to lead the implementation of a values-based compliance program in Nigeria and to promote a values-based culture in a way that supports GEC and Pharma strategies.
  • Partnering with Pharma senior business leaders to proactively identify, evaluate and manage risks, in accordance with Policy 500 and GSK internal control framework, in a way that enables sustainable business growth.
  • Advise the business on risks associated with emerging business strategies and provide pragmatic options for risk mitigation and management. Ensure that the Nigeria based business have an effective risk management strategy that aligns with GSK’s Risk Management methodology.
  • Ensuring adequate internal controls are in place across the Nigeria business by independently assessing efficiency of the internal control framework. Provide insight, best practice, guidance and assurance to build, test and validate the robustness of these business controls. Support delivery of clear and integrated compliance solutions.
  • Driving accountability throughout Nigeria to ensure greater business transparency, speak-up culture and reinforcing trust in GSK from customers, business partners, and patients.
  • In partnership with CIT (Corporate Investigation Team), HR and Legal ensuring that reported concerns are promptly and thoroughly investigated, with suitable corrective and remediation action and discipline when appropriate. Provide oversight on all investigations from his/her business.
  • In partnership with the business, ensuring adequate preparation for internal audits of significant compliance risks and delivery of prompt responses to audit findings.
  • Serve as the main contact and coordination point for independent business monitoring. Help to identify root cause issues to eliminate key risk areas
  • Act as the champion for GSK Values; driving our Values Assurance strategy into the depths of the organisation and increasing the values maturity of the organisation
  • Acting as a change leader for standardization where appropriate, to simplify the complexity of practices while maintaining adherence to GSK policy and Values.
  • Understanding the opportunity for business collaboration and new business models ensuring the risk management and controls framework is adequate.
  • Development of communication and training strategy of GEC and ad hoc implementation to fully embedding desired compliance culture within Nigeria.
  • Being the local expert on a wide range of compliance topics e.g. ABAC, TPO, Local Regulations and responsible for advising the Nigeria based staff on compliance with these areas
  • Engage with external parties to promote and defend GSK’s industry ethical lead and shape the external environment
  • As a key member of the PH and the Nigeria Country Executive Board, encourage discussion of relevant, significant risks and ensure that issues and conclusions are escalated upwards and consistently across the market
  • Participate in GEC initiatives/projects/working streams
  • Developing and implementing tools which empower employees to make ethical and legally compliant decisions. Provide compliance support to Nigeria based staff, as well as advisory and interpretation services in relation to GSK Policies and SOP as required.
  • Partner with other governance groups (e.g. HR, Finance, Medical, Legal) to develop integrated compliance solutions
  • Distill complex issues to create right-size, simple solutions to problems
  • Demonstrate learning agility and ability to learn new things quickly
  • Solid understanding of any relevant healthcare compliance standards in the market
  • Ability to influence leadership behaviours in line with GSK Values

Application of Knowledge:

  • Has a deep understanding of the BU’s products, competitors, industry issues and regulations.
  • Extensive knowledge and insight into global markets and underlying reasons for current conditions.
  • Understand how nuanced changes in strategy influence risk to GSK
  • Knowledge & experience with healthcare laws and requirements.
  • Knowledge & experience with compliance programs and processes
  • Ability to provide high degree of reliance and accountability to senior management
  • Strong advocacy skills and sound business judgment at senior levels
  • Organised and capable of working in an influencing role at all levels, particularly senior management levels
  • Excellent interpersonal skills to enable effective and influential internal and external contacts.
  • Experience dealing with government regulators and prosecutors
  • Possesses organisational knowledge required for identifying areas of compliance vulnerability and aligning the compliance functions with the business.
  • Knowledgeable of applicable government laws and regulations relating to the company.
  • Superior listening skills, analytical ability to diagnose problems, resolve conflict, and develop practical solutions.
  • Ability to manage sensitive confidential issues with complete discretion.
  • Demonstrated risk management, process improvement, and/or project management skills.
  • Maintain a high degree of credibility, independence, integrity, confidentiality and trust.
  • Exhibit strong analytical skills and an understanding of operational processes and technology concepts.
  • Strong writing skills required to write and edit policies and procedures, issue memoranda and compile program reports.
  • Exhibits excellent presentation skills with large and small audiences.
  • Good networker internally and externally to GSK

Problem Solving & Innovation:

  • A strong positive influence the culture of GEC and GSK to embrace GSK values decision making and effective risk management.
  • Viewed as a trusted team member by senior leaders and sought out for flexible thinking and strategic advice.
  • Establishing a culture and executing strategies which fundamentally raise the importance of customers in the organisation,
  • Champions project ideas.  Leads cross-organisation, complex projects. Supports development of new project managers.
  • Encourages and motivates peers and staff to give their best. Champions the development and success of the Compliance team. Create an environment that enables teams to perform at its best and builds trust and team spirit to enhance the effectiveness of the group.

Interaction:

  • Works with leadership teams to shape and define business strategies, working to manage the interface of agendas and drivers between other relevant areas of GSK. Helps the BU/Function evaluate multiple strategic alternatives.
  • Shares best practices with peers in the industry through informal discussions and presentations at educational events.

Impact:

  • Accountable for ensuring Nigeria compliance program is effective and fully implemented.
  • Accountable for implementation of compliance initiatives aligned with corporate initiatives e.g. following Strategic Review recommendations
  • Ensuring that GSK’s compliance culture is embedded at all levels of the organisation
  • Accountable for ensuring employees understand compliance requirements and use good judgment in activities and for ensuring appropriate monitoring and auditing to verify.
  • Manages policy and process enhancements and compliance issues and projects that apply to Nigeria and protect against significant liabilities.
  • Oversight of BU compliance champions, to ensure full deployment and coordination of corporate, Nigeria and BU risk management and compliance processes at all levels.
  • Establishes and maintains credibility and trust throughout the organisation and is able and willing to consistently advocate disciplinary actions for compliance and ethics violations.

Basic Qualifications

  • Degree in Business, Medical, Accounting, Engineering, Risk Management

Work Experience:

  • Minimum Level of Job-Related Experience required  5-10 year+ in Compliance/Audit/Legal/Internal Controls role
  • Prior experience is essential in facilitating judgment related decisions and implications of risk within a commercial business

Other Job-Related Skills/Background:

  • Good understanding of BU structures and processes.
  • Broad knowledge of GSK business and operating model
  • Expert level knowledge of Internal Control Framework and risk management principles and ability to translate theory into practice.
  • Good working knowledge of the GSK system of internal control, and its organisational elements.
  • Experience in audit, risk management, compliance and other governance fields desirable.
  • Ability to maintain confidentiality and trust around sensitive compliance issues.
  • Good degree of organisational awareness; demonstrated ability to develop solutions to complex problems and challenges.
  • Self-starter, results-oriented.
  • Ability to influence, coach and co-ordinate teams to initiate, plan, control and execute projects in smarter and more efficient ways, flexing the approach as needed for local context.
  • Familiarity with IT systems and technology, specifically Connect GSK, Teamsites, CDMS for storage and accessibility of policies
  • Teamwork – ability to work and contribute collaboratively as part of one team, respecting individual styles and cultural differences while focussed on delivery of the overall project objective.
  • Ability to work effectively and sensitively in a highly matrixed organisation across geographies and cultures.
  • Animation, facilitation and presentation skills
  • Detailed working knowledge of GSK Change Framework and Lean Sigma methodologies a plus
  • Enable and Drive Change: ability to define an approach that results in project stakeholders owning and sustain the change.
  • Flexible Thinking: Ability to flex and tailor standard approaches to fit the needs of the project and the local environment
  • Strong problem solving skills that are pragmatic, which demonstrates a strong understanding of the business.
  • Continuous Improvement: Determination and confidence to challenge the existing ways of working and shift current thinking to embrace working in a smarter, more efficient and simpler ways.
  • Relationship Building: Ability to build lasting, mutually beneficial win-win relationships with key project stakeholders and senior leaders
  • Strong interpersonal skills with excellent written and oral communication skills, including presentations to large and small audiences, with the ability to influence individuals at all levels of the organisation.
  • Demonstrated ability to work and influence others to work in accordance with company Values.

Application Closing Date
Not Specified.

How to Apply

Interested and qualified candidates should:
Click here to apply online

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SCOTUS weighs competing briefs in widow’s appeal in case vs GSK over suicide of lawyer taking generic Paxil


In coming weeks, the U.S. Supreme Court is expected to weigh in on the question of how much liability drug companies should face over the warning they give to doctors and patients of certain allegedly harmful side effects from their medications, particularly when those warning labels are closely controlled by federal regulators.

And the decision could have major implications for lawsuits against pharmaceutical companies, including a case decided last year by a federal appeals panel in Chicago, in a legal action brought by the widow of Chicago lawyer who committed suicide after taking the generic equivalent of the antidepressant, Paxil.

In recent weeks, attorneys for pharmaceutical company GlaxoSmithKline and for plaintiff Wendy Dolin filed competing briefs before the U.S. Supreme Court.

Dolin is asking the high court to toss out the decision of the U.S. Seventh Circuit Court of Appeals, which had, in turn, thrown out a jury verdict ordering GSK to pay Dolin $3 million.

In that decision, the Seventh Circuit judges had essentially found GSK could not be held liable for the content of the warning label on its medication, because those labels were controlled by the U.S. Food and Drug Administration.

Dolin had sued GSK in 2012, two years after her husband, Stewart Dolin, killed himself in a downtown Chicago transit station. Dolin alleged her husband was taking paroxetine, the generic version of GSK’s Paxil, at the time. She asserted the warning label for paroxetine, which was written by GSK and is identical to the warning label for Paxil, did not adequately warn the drug could increase the risk of suicide.

Dolin alleged GSK knew of the alleged increased risk, yet chose not to revise the warning label.

GSK, however, said it tried several times to secure approval from the FDA to revise the label, but the FDA declined.

After years of proceedings in federal district court in Chicago, a jury found in favor of Dolin at trial. GSK appealed, and the Seventh Circuit overturned the verdict.

Dolin then appealed to the U.S. Supreme Court, arguing the Seventh Circuit got it wrong. Dolin’s lawyers particularly argued the Seventh Circuit’s ruling conflicted with the Supreme Court’s 2009 ruling in Wyeth v Levine, which held drug companies with “clear evidence” of problems can revise labels to enhance warnings, without FDA approval.

Dolin’s attorneys also noted the decision conflicts with the decision of the U.S. Third Circuit Court of Appeals, which found in a similar case the FDA’s regulation of drug warning labels did not absolve pharmaceutical company Merck of liability for injuries allegedly suffered by patients who took Merck’s drug, Fosamax.

That case, docketed before the Supreme Court as Merck v. Albrecht, was argued before the Supreme Court in January. A decision could be forthcoming in the case in coming weeks.

No matter which way the court falls on the question, though, it may also decide the fate of the Seventh Circuit’s decision in the Dolin matter.

Dolin, in a brief filed April 11, asked the Supreme Court to hold off on deciding whether to take up her case until after it has decided the Albrecht case.

“At the heart of the pending Albrecht decision is an analysis of what was presented to the FDA, how the FDA responded, and what warning (if any) the FDA rejected…,” Dolin’s attorneys wrote.

“This is exactly the issue in this case, i.e., when the FDA through informal communications stated that GSK’s proposed Paxil-specific adult warning should not go in the middle of the class-labeling section (as that applied to the whole class of drugs), but that GSK should submit a formal (Changes Being Effect) supplement that the FDA could review independent of the class-labeling being implemented for over 30 different antidepressants, was the FDA rejecting a Paxil-specific adult warning? Every jury and virtually every jurist (with the exception of the Seventh Circuit panel …) has answered this question in the negative.”

GSK, however, in a brief filed in late March, asserted the Seventh Circuit’s decision is on firm legal footing, no matter the outcome in Albrecht.

“This Court’s resolution of that dispute, … will not affect the outcome here,” GSK argued in its brief. “The (Seventh Circuit) court of appeals here found that the ‘undisputed evidence’ regarding FDA’s decision-making was subject to only one reasonable interpretation: FDA, after exhaustively studying the issue for years, definitely and repeatedly rejected an adult-suicidality warning based on substance and science.”

GSK also asserted the decision was sound, even when posed against Wyeth, as the Seventh Circuit found “no reasonable jury could find that the FDA would have approved an adult-suicidality warning for Paxil … between 2007 and Stewart Dolin’s suicide in 2010.”

Aside from the Seventh Circuit’s findings, GSK also asked the Supreme Court to note Dolin’s lawyers were essentially attempting to use a warning label suit to hold GSK liable for the alleged effects of a generic medication it did not make, sell or distribute, under a theory called “innovator liability” – making the innovator of a product pay for the alleged damage caused by a copy of its original product, made and sold by someone else.

“But such a theory of liability is untenable,” GSK wrote. “Holding brand manufacturers liable for injuries allegedly caused by generic manufacturers would up-end tort principles, deter medical innovation, and require brand manufacturers to insure an entire industry when their patents have long since expired and they no longer profit from the drug.”

GSK asked the Supreme Court to reject the appeal, and not hear arguments in the case, allowing the Seventh Circuit decision to stand.

Supreme Court justices are scheduled to consider whether to hear arguments in the Dolin case at a conference April 26, according to the court’s docket.

Dolin is represented by attorneys with the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles, and the Rapoport Law Offices P.C., of Chicago.

GSK has been represented by the firms of Arnold & Porter Kaye Scholer, and  and Williams & Connolly LLP, each of Washington, D.C., and by the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta.