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Pharmaceutical company seeks Associate General Counsel, FDA focusing on research and development activities. The successful candidate for this position will be someone with significant, specialized experience with global regulatory requirements in the bio/pharma industry and a strong team orientation. This attorney will work with other attorneys in the company’s Legal Department on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D and clinical compliance regulations. The successful candidate will have direct client responsibility in support of a broad range of company R&D related activity and may also serve as a dedicated lawyer for one or more of the company’s late stage development programs. Position reports directly to the VP, Chief R&D Counsel. Specific responsibilities may include: Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate and advise on label and approval challenges. Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global agencies that may affect our product approvals and marketed products. Advise Drug Safety on recent developments in risk management Proactively identify and manage risk profile of products in development to be best prepared to prevent and address clinical trial and post marketing products liability claims. Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing safety commitments.
Pharmaceutical company seeks Associate General Counsel, FDA focusing on research and development activities. The successful candidate for this position will be someone with significant, specialized experience with global regulatory requirements in the bio/pharma industry and a strong team orientation. This attorney will work with other attorneys in the company’s Legal Department on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D and clinical compliance regulations. The successful candidate will have direct client responsibility in support of a broad range of company R&D related activity and may also serve as a dedicated lawyer for one or more of the company’s late stage development programs. Position reports directly to the VP, Chief R&D Counsel.
Specific responsibilities may include:
JD 10+ years experience with global regulatory requirements in the biotechnology or pharmaceutical industry required. Experience with regulatory submissions, requirements and drug safety management is required. Experience with government affairs, FDA and EMA regulations are required. Must have excellent interpersonal, decision making and communication skills.
Technology company seeks Legal Counsel. The role involves providing legal services in support of the company’s global operations functions. The role covers a wide variety of commercial matters, including IT, and outsourcing. The successful candidate must provide practical, commercial solution-driven advice and would need to have a strong commercial background with broad-ranging technology experience. The candidate should be enthusiastic and proactive and be able to work with minimal supervision. The candidate should be comfortable supporting senior executives and working on projects with cross-functional business teams. The role involves a wide variety of work, including: Drafting and advising on a variety of technology contracts, such as software as a service agreements, software development agreements, IT services agreements and software licences (both fee bearing and open source). Drafting and advising on business process outsourcing contracts, including data processing activities, call centres, etc. Drafting and advising on a variety of commercial agreements, such as supply/purchase contracts, services agreements and non-disclosure agreements. Drafting and advising on a variety of data contracts, such as hosting agreements and data processing agreements.
Technology company seeks Legal Counsel. The role involves providing legal services in support of the company’s global operations functions. The role covers a wide variety of commercial matters, including IT, and outsourcing. The successful candidate must provide practical, commercial solution-driven advice and would need to have a strong commercial background with broad-ranging technology experience. The candidate should be enthusiastic and proactive and be able to work with minimal supervision. The candidate should be comfortable supporting senior executives and working on projects with cross-functional business teams.
The role involves a wide variety of work, including:
The successful candidate must complement the small, dedicated, collaborative and passionate, existing in-house team. A good team spirit and a practical and commercial approach to problem solving are essential. The successful candidate must: be legally qualified; have solid general commercial and technology law experience at the 5-7 year level obtained at a major firm and/or in-house law department; have excellent communication skills; demonstrate a strong analytical mind, an aptitude for problem solving and excellent drafting skills; be proactive at developing internal business relationships; be a confident team player with an encompassing attitude to the the entire Group Legal & Secretariat Team globally; exercise commercial and pragmatic judgment in the advice given and solutions provided; be motivated, enthusiastic and have a “can do” attitude; and demonstrate attention to detail. Behavioural Competencies Communication Continuous Improvement Customer Focus Deliver Results Information Technology Interpersonal Skills Planning & Organising Problem Solving Self-Management Teamwork
The successful candidate must complement the small, dedicated, collaborative and passionate, existing in-house team.
A good team spirit and a practical and commercial approach to problem solving are essential.
The successful candidate must:
Behavioural Competencies
Medical device company seeks Senior Counsel, Research. The Senior Counsel, Research is primarily responsible for structuring and negotiating research arrangements with key research sites and participating in the company research review processes. These research arrangements may include a wide range of the company’s medical device equipment and software. His/her tasks would also include structuring contracts with research consortia and advising on related funding arrangements. Essential Responsibilities Working with the research, technology/engineering, product P&L, and intellectual property teams as a business partner to review and formalize research opportunities, and to resolve legal issues that arise in ongoing research arrangements in order to drive business product development forward Drafting, reviewing, negotiating, and assisting in managing strategic research agreements Advising the business on Good Clinical Practices (GCP), Fraud and Abuse, Regulatory, Privacy, Advertising/Promotional matters and other legal issues that arise in the research context Participating in the company research approval processes Providing regulatory and compliance advice in conjunction with the Regulatory, Finance, and Compliance specialist areas in the company Develop and deliver research training and associated resource materials as needed Consult with Medical Affairs and Clinical Affairs on adverse event evaluation and reporting Managing outside counsel when brought in to assist Applying combined business and legal judgment to proposed research arrangements, ongoing research relationships and other issues requiring legal or compliance attention Quality Specific Goals: Aware of and comply with the company Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position Complete all planned Quality & Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required
Medical device company seeks Senior Counsel, Research. The Senior Counsel, Research is primarily responsible for structuring and negotiating research arrangements with key research sites and participating in the company research review processes. These research arrangements may include a wide range of the company’s medical device equipment and software. His/her tasks would also include structuring contracts with research consortia and advising on related funding arrangements.
Essential Responsibilities
Quality Specific Goals:
JD (or equivalent) with active bar membership 8 years of legal work experience, with at least 4 years of health care experience at a large law firm, corporate legal department, government agency, or research organization, including previous experience drafting and negotiating research agreements Well-versed in GCP principles and research regulations with some experience with enforcing research compliance Previous relevant experience with IP issues as related to research projects Experience in, or advising the Healthcare industry, and previous exposure to medical industry regulations (FDA, Medicare/Medicaid Anti-Kickback, Privacy) Previous experience in identifying and resolving legal issues quickly and effectively and ability to make challenging risk decisions Previous experience prioritizing conflicting demands from multiple business clients in an extremely fast paced environment Desired Characteristics Experience working on global research projects Experience working with contract research organizations Demonstrated experience providing legal advice in a highly regulated environment Experience or familiarity working with academic research centers
Desired Characteristics
Life sciences company seeks Division Counsel, Compliance. Provides legal services and resolves complex legal matters for assigned responsibilities or clients. Supports the business in the achievement of business objectives by rendering sound legal advice and managing legal risks to the corporation. CORE JOB RESPONSIBILITIES: The Division Counsel is the most senior-level individual contributor or the first level supervising attorney in the company’s Legal Division. The Division Counsel: Identifies highly complex legal issues related to assigned matter; develops alternative solutions, and implements resolution. Resolves complex to highly complex legal matters in practice area independently. Leads cross-functional projects. Possesses in-depth knowledge of the company’s businesses supported and knowledge of the broader business impact. Keeps abreast of changes in laws that affect client areas and advises clients on such changes. Regularly negotiates independently with customers, suppliers or government agencies on matters of strategic importance that affect a substantial portion of the company’s business or areas of significant importance to senior management. Selects and directs the work of outside counsel, defines project objectives and manages project. Identifies unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company. COMMENTS: · Mentors, coaches and directs assigned attorneys and support staff; serves as a role model and as a champion of the legal department through work ethic, attitude, interpersonal skills and successful results. May have attorney and support staff direct reports with people management responsibility (performance, pay increases, development, etc), but not required. Plays a key role in selecting, recruiting and developing attorneys and support staff. Provides input into attorney performance evaluations, merit increases and developmental planning and assignments. Reports to Associate General Counsel. POSITION ACCOUNTABILITY / SCOPE: Advises legal department managers of critical project developments in a timely manner. Executes core job responsibilities in a timely manner. Assigned matters have significant impact to Abbott overall. Advises Managers, Directors, Division Vice Presidents and Officers. Recognized by these clients as both expert in substantive area and relied upon for individual advice. May have direct budget responsibility and manages significant budget issues. Develops and manages budgets for assigned legal matters. Serves as a recognized resource for both management and other attorneys on innovative ideas in highly complex areas of the law.
Life sciences company seeks Division Counsel, Compliance.
Provides legal services and resolves complex legal matters for assigned responsibilities or clients. Supports the business in the achievement of business objectives by rendering sound legal advice and managing legal risks to the corporation.
CORE JOB RESPONSIBILITIES:
The Division Counsel is the most senior-level individual contributor or the first level supervising attorney in the company’s Legal Division.
The Division Counsel:
COMMENTS: · Mentors, coaches and directs assigned attorneys and support staff; serves as a role model and as a champion of the legal department through work ethic, attitude, interpersonal skills and successful results.
POSITION ACCOUNTABILITY / SCOPE:
· Generally 10+ years of relevant experience · Expert in practice area
· Generally 10+ years of relevant experience
· Expert in practice area
Medical device company seeks Compliance Director. PRIMARY JOB FUNCTION: Provides direct oversight for complex elements of the company’s compliance program at the franchise, business unit, regional, divisional or corporate level. Responsible for directing the development and administration of Office of Ethics and Compliance education and training, and development and implementation of divisional monitoring plan, identifying compliance risk areas and communicates such risk areas to division management along with action plans to address risk. CORE JOB RESPONSIBILITIES: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. The Director performs the following with minimal supervision from Ethics and Compliance Officer. – Provide leadership, guidance and support to all levels of key divisional business functions on complex ethics and compliance issues, including policy interpretation and requirement, compliance risk assessment, trend analysis and best practice recommendations. Resolves complex ethics and compliance matters that have significant impact to the company. Directs and conducts periodic reviews and updates related to complex Office of Ethics and Compliance policy and divisional/affiliate procedures ensuring clarity, applicability and compliance to OEC policy and external requirements with minimal supervision from Ethics and Compliance Officer. Develops, updates, implements, and delivers Office of Ethics and Compliance’s comprehensive training program on complex Office of Ethics and Compliance and divisional/affiliate policies and procedures. Provides oversight to corporate and/or divisional monitoring process to ensure compliance with OEC/affiliate policies and procedures. Reviews industry trends and internal results, and recommends corrective actions. Partners with Ethics Compliance Officer and business on compliance audits, oversees the fulfillment of auditors requests, acts as liaison between business and auditors during on site activities, evaluates and responds to all complex preliminary findings and recommendations, guides the business in preparing corrective action to address complex and highly complex findings and recommendations. Oversees all Compliance Review Committees at the divisional or affiliate level and provides input on violation process. Reviews internal trends and implement corrective actions. Provides leadership and guidance on proposed commercial programs, identifies complex legal and regulatory issues, analyzes alternatives and works with legal, as appropriate, to propose solutions to the business. Possesses in-depth knowledge of the company’s businesses supported and knowledge of the broader business impact. Leads cross-functional teams on complex issues or projects. POSITION ACCOUNTABILITY / SCOPE Accountable to Ethics and Compliance Officer and senior divisional management. Assigned matters/business units have significant impact to the company’s compliance program. Operates with autonomy and limited supervision. Provides guidance and direction to Coordinators, Compliance Analysts, Compliance Managers as needed.
Medical device company seeks Compliance Director.
PRIMARY JOB FUNCTION:
CORE JOB RESPONSIBILITIES: Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
POSITION ACCOUNTABILITY / SCOPE
Accountable to Ethics and Compliance Officer and senior divisional management.
Minimum of 8 years experience with, or exposure to, business functions such as compliance, legal, regulatory affairs, government affairs, and finance. BA/BS required. CPA, Masters, JD, or equivalent work experience strongly preferred.
Minimum of 8 years experience with, or exposure to, business functions such as compliance, legal, regulatory affairs, government affairs, and finance.
BA/BS required. CPA, Masters, JD, or equivalent work experience strongly preferred.
Medical device company seeks Director Compliance. Responsibilities include but are not limited to implementing and managing programs under the company’s Compliance Program with an emphasis on assisting the Vice President – Chief Compliance Officer with developing, implementing and monitoring a comprehensive and effective corporate compliance program. Additionally, the person in this position will be responsible for collaborating with key stakeholders in various functional areas, including the commercial teams, to advise them on developing compliance controls, objectives and strategies to promote adherence to applicable laws, regulations, company policies and industry standards. Other responsibilities include promoting a culture of compliance and ethics within the company. ESSENTIAL DUTIES AND RESPONSIBILITIES Participate in various company policy working groups in the development and drafting of corporate policies and procedures and standards. Promote and ensure compliance to the Global Code of Conduct as well as all company policies and procedures Participate in the compliance training program including coordinating with vendor partners and internal stakeholders to develop, launch, and oversee training campaigns Deliver live training to both field-based and home-office employees to ensure awareness and understanding of the laws, regulations, corporate policies and industry standards that apply to their position Provide advice to stakeholders as it relates to compliance with applicable laws, regulations, company policies and industry standards Promote a culture of compliance and ethics within the company Address questions from employees on compliance related matters Participate in reviews of compliance program effectiveness for prioritized risk and/or business areas Partner closely with Internal Audit and Legal in the design, execution and remediation plans for Compliance Audit and monitoring activities Assist with, and in some cases lead compliance investigations, internal and external compliance audits. Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of the company are carried out with the best industry practices and the highest ethical standards
Medical device company seeks Director Compliance. Responsibilities include but are not limited to implementing and managing programs under the company’s Compliance Program with an emphasis on assisting the Vice President – Chief Compliance Officer with developing, implementing and monitoring a comprehensive and effective corporate compliance program. Additionally, the person in this position will be responsible for collaborating with key stakeholders in various functional areas, including the commercial teams, to advise them on developing compliance controls, objectives and strategies to promote adherence to applicable laws, regulations, company policies and industry standards. Other responsibilities include promoting a culture of compliance and ethics within the company.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Bachelors degree required, advanced degree (e.g., JD, MPH, MBA.) preferred. Strong business knowledge required with 5-7 years of overall compliance experience in a government regulated health care industry, e.g. medical device, pharmaceuticals, hospitals. Proven success within multi-disciplinary/global teams Proven experience in managing change Must have demonstrated capabilities in working with cross-functional teams, devising complex procedures or processes and implementing change. The position requires the ability to manage and lead several short term and long term projects. Must have strong coordination skills and the ability to work closely with and effectively influence people across the company at different levels of the organization. Experience in handling confidential and sensitive situations or information with ability to exercise a high degree of judgment and discretion. Strong written and oral communication skills.
Life science company seeks Senior Counsel for Global Privacy to advise on privacy laws globally in every country where the company has employees, markets its products or conducts clinical research. This role is the company’s most senior position dedicated to privacy and plays a key part in providing leadership to the privacy function for the company. Duties involve counseling clients on compliance with a wide range of U.S. and international laws in the areas of HIPAA/privacy and e-business. Duties will likely include providing counsel with regard to pending and enacted state legislation in the health care compliance area and with regard to, Medicare/Medicaid fraud and abuse laws generally. Duties include: Developing policies and procedures on addressing privacy compliance and appropriate use of clinical, consumer and employee personal data Counseling the business on structuring policies, contracts and business practices to maximize business utility of personal data in compliance with global privacy laws Managing the company’s legal privacy team, including one senior privacy counsel in Europe and three senior privacy paralegals Coordinating the company’s five standing privacy working groups and advising on the use of personal data for HR, IT, clinical, commercial and purchasing functions Serving as the coordinator of the company’s Incident Response Team for handling data security breaches Participating as member of Legal Regulatory & Compliance group’s senior staff Guiding work of supporting outside privacy counsel and managing privacy outside counsel budget Representing the company on the International Pharmaceutical Privacy Consortium board of directors
Life science company seeks Senior Counsel for Global Privacy to advise on privacy laws globally in every country where the company has employees, markets its products or conducts clinical research. This role is the company’s most senior position dedicated to privacy and plays a key part in providing leadership to the privacy function for the company.
Duties involve counseling clients on compliance with a wide range of U.S. and international laws in the areas of HIPAA/privacy and e-business. Duties will likely include providing counsel with regard to pending and enacted state legislation in the health care compliance area and with regard to, Medicare/Medicaid fraud and abuse laws generally.
Duties include:
Duties include: Developing policies and procedures on addressing privacy compliance and appropriate use of clinical, consumer and employee personal data Counseling the business on structuring policies, contracts and business practices to maximize business utility of personal data in compliance with global privacy laws Managing the company’s legal privacy team, including one senior privacy counsel in Europe and three senior privacy paralegals Coordinating the company’s five standing privacy working groups and advising on the use of personal data for HR, IT, clinical, commercial and purchasing functions Serving as the coordinator of the company’s Incident Response Team for handling data security breaches Participating as member of Legal Regulatory & Compliance group’s senior staff Guiding work of supporting outside privacy counsel and managing privacy outside counsel budget Representing the company on the International Pharmaceutical Privacy Consortium board of directors
Life sciences company seeks Senior Counsel, Compliance to be primarily responsible for managing all aspects of policy compliance, including, but not limited to: strategic understanding of risks and policies needed to mitigate risks, provision of domain expertise in health care laws such as AKS, FCA, HIPAA, etc., interpretation for implementation of new health care laws impacting business, & trending analysis to provide strategic information to support the Senior Leadership/Executive teams. Essential Responsibilities Validate Training Materials in accordance with Policies, Laws and Regulations, and coordinate completion within the company`s businesses Advising the business on regulatory, advertising/promotional, and other matters Supporting the creation of processes and programs to ensure business compliance to such policies, laws and regulations Providing regulatory and compliance advice Creating legal forms and best practices Conducting dynamic live training to influence and educate business Collaborating with investigations counsel to determine appropriate corrective action is identified and implemented Coordinate periodic process audits for the business Managing outside counsel Generally applying combined business and legal judgment to proposed deals, relationships and other issues requiring legal or compliance attention
Life sciences company seeks Senior Counsel, Compliance to be primarily responsible for managing all aspects of policy compliance, including, but not limited to: strategic understanding of risks and policies needed to mitigate risks, provision of domain expertise in health care laws such as AKS, FCA, HIPAA, etc., interpretation for implementation of new health care laws impacting business, & trending analysis to provide strategic information to support the Senior Leadership/Executive teams.
JD or equivalent degree outside of the US Must have US Bar or be a qualified lawyer in specific country of practice Minimum 7 years of experience at a large law firm or corporate legal department, including recent health care compliance experience Demonstrated experience identifying and resolving legal issues quickly and effectively and ability to make on the spot risk calls. Demonstrated experience prioritizing conflicting demands from multiple business clients in an extremely fast paced environment. Demonstrated experience providing legal advice in a highly regulated environment Previous work experience in the Healthcare industry and exposure to medical industry regulations (FDA, Medicare/Medicaid/Anti-Kickback) Outstanding interpersonal skills and ability to communicate and influence at all levels of the organization (including our field sales force, senior leadership and our customers’ senior leadership teams) Ability to work well independently and in a team setting Excellent communication skills with the ability to communicate business issues in an easy to understand manner Global mindset, able to deal with people from all different backgrounds and cultures. Credible change agent Ability to work within a matrix organizational environment and to interact with executives at the most senior levels Strong interpersonal skills and demonstrated teamwork skills
Pharmaceutical company seeks Director or Senior Director, Compliance. Responsibilities include but are not limited to implementing and managing the company’s Corporate Compliance Program, with an emphasis on assisting the Chief Compliance Officer with developing, implementing and monitoring corporate policies and procedures and commensurate training programs. Additionally, the person in this position will have primary responsibility to manage compliance with the myriad State and Federal reporting requirements governing commercial pharmaceutical operations including but not limited to state gift, marketing and lobbying reports and sample accountability. The ability to handle multiple tasks in a fast-paced environment is essential. Willing to take initiative, proactive and good people skills are a must. An attention to detail good organizations skills, and the discretion to work on confidential investigations are also essential. ESSENTIAL FUNCTIONS Perform duties of the Secretariat of the Corporate Policy Review Committee which includes developing and assessing the corporate policy structure, coordinating policy working groups, and drafting corporate policies and producers as necessary. Assist in the management of Compliance on-line training tool, including developing, launching, and overseeing training campaigns. Help develop training modules and programs to ensure that company employees are aware of and understand the corporate policies that apply to their position. Develop compliance communications and awareness campaigns. Review and assess company obligations under state and/or federal gift, marketing and lobbying reporting statutes. Assess completeness of information sourcing from internal sources (STARs, etc.) File any and all necessary reports mandated under state and/or federal gift, marketing and lobbying reporting statutes. Assist with compliance investigations led by the Compliance Department. Monitor state and federal legislative proposals that may create a compliance obligation for the company if enacted. Assist and manage collection of documentation necessary to obtain licensing in various states and territories throughout the U.S. Track expenditures for California to protect against and identify any expenditure that exceeds the company imposed cap. Assist on Fraud & Abuse/False Claims Act auditing and monitoring initiatives. Promote and ensure compliance to the Code of Ethics as well as all policies and procedures. Address queries from the business field and satisfy requests for research related to specific legislation/regulations. Create compliance bulletins and update/maintain compliance tracking and filing system.
Pharmaceutical company seeks Director or Senior Director, Compliance. Responsibilities include but are not limited to implementing and managing the company’s Corporate Compliance Program, with an emphasis on assisting the Chief Compliance Officer with developing, implementing and monitoring corporate policies and procedures and commensurate training programs. Additionally, the person in this position will have primary responsibility to manage compliance with the myriad State and Federal reporting requirements governing commercial pharmaceutical operations including but not limited to state gift, marketing and lobbying reports and sample accountability.
The ability to handle multiple tasks in a fast-paced environment is essential. Willing to take initiative, proactive and good people skills are a must. An attention to detail good organizations skills, and the discretion to work on confidential investigations are also essential.
ESSENTIAL FUNCTIONS
Education level and/or relevant experience(s): A JD is preferred although other advanced degrees along with direct experience in pharmaceutical or medical device compliance will be considered. A minimum of 3-5 years (Director) of experience in compliance in a life sciences company or a related role in Legal, Regulatory or Medical Affairs. 7-10 years experience for the Senior Director level. Knowledge and skills (general and technical): Strong business, legal and/or regulatory knowledge required (experience working in-house at a pharmaceutical or life sciences company is preferred). Experience in handling confidential and sensitive situations or information with ability to exercise a high degree of judgment and discretion.
Education level and/or relevant experience(s):
Knowledge and skills (general and technical):
