Lundbeck LLC
At Lundbeck, our mission is to improve the quality of life of people suffering from psychiatric and neurological disorders.
 
As a pioneer at the forefront of brain disorders for more than 60 years, Lundbeck is committed to developing and providing innovative therapies that help improve the quality of life of patients. This is important work because the burden of neurological and psychiatric disorders remains substantial. When we assess a medical condition, we see the person behind the disease and how it affects the lives of patients, their families, their caregivers and their communities.

What sets us apart:

Research: A deep pipeline – 100 percent targeted to brain disorders – in challenging areas like depression and anxiety, psychosis, epilepsy, Alzheimer’s disease and stroke.
 
Patients: A passion for patients that binds us together and drives us to act with urgency to address unmet medical needs today and into the future. 

Partnerships: A long history of successful and diverse partnerships at all stages of a product’s lifecycle
Jul 19, 2018
Senior Manager, Benefits SUMMARY: No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them. The Senior Manager, Benefits is responsible for leading and managing the design, implementation, communication, performance and administration of the comprehensive Lundbeck US/NA Health & Welfare Benefit Plans and other HR operational programs. This individual works in alignment with HR objectives and company strategy to benchmark, recommend, customize, and implement programs, with focus on employee advocacy, and continuous assessment and improvement. To be successful initially and long-term, the Senior Manager, Benefits is expected to take ownership of our Benefits approach, learn our culture and processes, drive to make impact, and contribute proactively and enthusiastically to the success of the HR team and Company. This individual manages one direct report. The major areas of focus for the incumbent in this role are: Benefits Medical (incl. Rx) Dental Vision STD / LTD Life Insurance (Basic & Voluntary/Supplemental) AD&D Insurance Health Savings & Flex Spending Accounts Employee Assistance Program (EAP) Leave Management and Administration PTO (Vacation/Holiday/Sick/Personal) New Hire Orientation / Employee Experience Education Assistance / Tuition Reimbursement Health Club Reimbursement 401(k) COBRA Severance Wellness program/activities Workers Compensation The incumbent in this role will work to ensure our employee programs: Are effective, competitive and compliant Align with the strategy of our business and support Lundbeck’s Shared Beliefs, and Support our goal to attract, retain, recognize, reward, engage and motivate our employees ESSENTIAL FUNCTIONS: Leadership/Management of Benefit Programs Manages and advances Benefits direction and programs to align with business strategy, and ensures the right mix and offerings are available to attract and retain desired talent. Manages overall Health and Welfare and retirement function and responsibilities. Acts as lead in making sure program set-ups include efficient resolution of any problems, escalations, corrections, claims or appeals. Leads Health & Welfare annual open enrollment. Plays lead role in plan renewals, evaluating trends/cost and proposing potential plan redesign options. Leads all facets of Lundbeck’s 401(k) retirement program, including providing direction and guidance to the Company’s 401(k) Committee. Helps ensure leadership, line managers and employees understand Benefit programs, Reward programs, and other related HR programs. Provides input, oversight, guidance, support and influence where appropriate. Educates, updates, informs, trains and partners with full HR team as it relates to Benefits/Rewards offerings. Partners and provides input/expertise to internal groups (e.g.; Payroll, Finance, Legal) in the administration, interpretation and communication of policies and programs. Partners and acts as contact with Benefits broker on all benefit issues, including monthly and annual review of health Benefits, costing, and plan design changes. Partners in developing and implementing a comprehensive communication strategy for Benefits programs. Evaluates, recommends and implements improvements to internal Benefits processes. Performs responsibilities as a balanced advocate for employees and Company. Compliance Acts as primary lead for all Benefits related compliance activities and ensures compliance with all benefit laws and regulations. Plays lead role in managing and updating the Summary Plan Descriptions for all Benefit Plans. Manages the 5500 process, the 1095 tax reporting process and other required compliance tests. Coordinates activities with all appropriate internal and external parties. Ensures compliance of plans as governed by Health Care Reform, ERISA, IRS and DOL. Ensures company is current and compliant on applicable laws/state leave programs. Supports audit process for all benefit plans, including annual 401(k) plan audit. Ensures all plans (qualified, non-qualified, defined contribution) are accurately administered in accordance with plan documents and applicable regulations. Manages and streamlines Benefits policy documentation and practice. Leaves of Absence and Time Off: Policies and Practices Recommends and oversees Company’s leave of absence policies and practices, including FMLA, USERRA, state mandated leaves, parental leaves, personal leaves and situational leaves. Provides guidance on FMLA/ADA/personal and parental leave policies, ensuring consistent application and compliant administration with all state and federal regulations. Develops time-off and paid time off policies in partnership with HR and Company leadership. Benchmarking, Analytics and Assessment Continually reviews, assesses and benchmarks Benefits offerings, programs, and technologies. Owns Benefits related benchmarking survey practice, data gathering and analysis of competitive market and trends to understand competitive market. Understands internal culture and employee population with intention to deliver most impactful, relevant and valued offerings. Monitors and analyzes Benefit Plans usage , service, coverage, effectiveness, cost, and plan experience. Develops and manages scorecard and dashboard reporting of Health & Welfare Plans. Provides specific recommendations based on trends, value, utilization and analysis. Acts as lead HR liaison with Finance to manage and participate in the process for Benefits forecasting, budgeting and monthly plan costs. Processes and monitors Benefits related invoices. In partnership with Finance, assures all Benefits spend is accounted correctly. Identifies and recommends opportunities to improve. Broker/Third Party Solutions and Partners Manages broker, vendors and third party solution provider relationships. Prepares and executes, with legal and Sourcing consultation, insurance and third party vendor contracts ensuring accordance and service delivery consistent with contract terms. Plays lead role in vendor/broker Benefits relationship, including: defining and monitoring measures, parameters, expectations, content and performance of external partners; ensuring effective service delivery; participating in contract renewals and negotiations; providing specialized support and ongoing training to Employee Resource Center; and providing direction on non-routine situations. Acts as primary liaison to ensure optimal vendor efficiencies are created and used REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited Bachelor’s Degree Subject matter expert in Health & Welfare plan design and administration, including in-depth knowledge of medical and Rx program management 8+ years progressive Benefits experience 5+ years demonstrated successful experience developing, shaping and managing employee benefit programs (e.g., medical, dental, vision, retirement, insurance, disability) Ability to balance employee advocacy and Company responsibility Ability to understand, interpret and apply appropriate provisions of applicable laws, ordinances, policies, rules, regulations, and memoranda of understanding Well versed in pertinent federal and state regulations, filing and compliance requirements (i.e., including ERISA, ACA, HIPAA, COBRA, FMLA, FLSA, IRS, ADA, Section 125 regulations, 5500, Health Care Reform, Workers Compensation, Medicare, Social Security, DOL) Clear, precise and effective verbal and written communication and presentation skills Ability to deal WITH benefits/personal matters in a confidential, objective and professional manner Ability to handle sensitive information and exercise sound judgment. High degree of professionalism. Results driven with ability to operate independently and proactively Proven ability to establish rapport and work across all levels of organization and cultivate relationships to include Legal, Finance and Senior Management Proficient with overall Microsoft Office suite. Strong Excel and PowerPoint skills Ability to drive multiple projects simultaneously with regularly adjusting priorities Proven analytic and business skills. Demonstrated ability to draw conclusions and trends from data analysis and offer appropriate solutions. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Industry designations (CEBS, PHR, etc.) Experience working with and benching Life Sciences/Specialty Pharmaceutical Organizations Experience with managing Benefit broker relationship Experience with SuccessFactors, BenefitFocus, and/or ADP Payroll Experience forecasting impact and cost of new or enhanced Benefits programs Experience partnering with vendors and optimizing vendor relationships Familiarity/Experience with Benefit Programs and offerings in Canada TRAVEL Willingness/Ability to travel typically 10-15% domestically; plus International travel to our Corporate Headquarters (Copenhagen, Denmark) may be warranted once per year
Lundbeck LLC Deerfield, IL, USA Full-Time
Jul 11, 2018
Administrative Assistant SUMMARY:   No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.   For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them. The A dministrative Assistant position provides professional administrative services to two departments - Human & Financial Resources, and Public Affairs. In order to support and improve overall operating efficiency, the individual in this role works under general guidance to plan, prioritize, communicate and organize workloads, and takes responsibility for special projects as needed by the two departments. ESSENTIAL FUNCTIONS: Provides professional administrative support to the Human and Financial Resources, Public Affairs  Departments, which includes (but is not limited to): Administering E-mail and Calendaring via Outlook Organizing meetings, room reservations, Video conferencing, Tele-conference calls and meal catering Processing contracts through the Ariba system Processing Purchase Orders through the SAP system Coordinating travel arrangements in line with company travel policy (air, hotel, car, transfers, and rail) Compiling, processing and submitting expense reports utilizing Concur, Bank of America and Works system Processing Department/company check requests Processing Charitable Donations through Salesforce.com system Maintaining and coordinating off-site record management Coordinating interview process (scheduling, travel logistics and point of contact) Serving as Department point of contact for BrainWeb Managing departmental logistics: distributing mail, producing and distributing correspondence memos, letters, distributions lists, organizational charts, misc. lists, reports, faxes, forms, and ordering office supplies Serving as project lead/coordinator for on and off-site meetings/functions to include; department communications, meeting rooms, catering, travel and other misc. logistics Acting as Department lead and point of contact to assist Corporate Management, Lundbeck US/North America, Lundbeck Affiliates, Alliances, Visitors or New Employees within the supported departments Providing front desk and other department back-up and/or relief as required REQUIRED EDUCATION, EXPERIENCE and SKILLS: High School Diploma/GED Proficient with computers, including MS Suite 3+ years of customer service or administrative support experience Ability to support multiple individuals and to handle day-to-day activities in a fast-paced, ever-changing environment while meeting important deadlines on various projects A self-starter with excellent time management/organizational skills and ability to multi-task and prioritize work. Attention to detail, planning and problem solving skills. Anticipate and advise on departmental needs Ability to work well in a team and/or individual environment and capable of setting/accomplishing set objectives with minimal supervision   Clear and professional written, oral, and interpersonal skills Ability to handle sensitive information with highest degree of discretion, integrity and confidentiality Outgoing, flexible, high-energy, detail oriented and self-motivated individual PREFERRED EDUCATION, EXPERIENCE AND SKILLS: 3+ years direct department support experience Proficiency with MS Access Accredited BS/BA degree TRAVEL No overnight travel requested unless unique circumstances arise
Lundbeck LLC Deerfield, IL, USA Full-Time
Jul 11, 2018
Senior Associate, Regulatory Affairs Operations SUMMARY: No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.   For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them. The Senior Associate, Regulatory Affairs Operations works independently to support activities related to the review, tracking, compilation, publishing, technical validation, submission and archiving of regulatory submissions to health authorities worldwide.  The Senior Associate will ensure conformance with regulatory requirements, guidelines, internal standards and timelines. ESSENTIAL FUNCTIONS: Manages and prepares IND, NDA, BLA and DMF lifecycle and original IND regulatory submissions in eCTD format including: technical review of critical components for accuracy; compliance with Health Authority requirements and internal standards. Coordinates the submission of annual reports and ensures timely, compliant submissions. Works directly with submission owners to prioritize submissions and maintain submission schedule. Coordinates and provides oversight to contractor support for regulatory submissions. Utilizes various software tools and plugins to ensure documents and submissions meet all technical requirements for submission. Develops, maintains and assists with training on training and tracking materials documenting regulatory lifecycle submissions and processes. Creates and ensures document/submission index is complete and accurate to ensure a complete, compliant, quality submission and archival in our EDMS. Supports the registration, renewal, transfer of products in International markets for Lundbeck US and Lundbeck HQ as needed. Provides support to Records & Information Management in the maintenance and archiving of regulatory documentation in Central Files. Works in conjunction with team members to develop processes for the creation of electronic submission ready documents. Provides ad-hoc submission support to RA Staff. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 3+ years experience in Regulatory, Regulatory Operations or R&D Submission Support function within the pharmaceutical industry 2+ years experience working directly with eCTD publishing software Proficiency with MS-Office Suite and Adobe Acrobat Demonstrated experience with Adobe plugins, e.g. ISI Toolbox Experience and demonstrated proficiency with document management systems Demonstrated ability to adjust priorities to successfully complete multiple tasks with similar deadlines Attention to detail and strong organizational skills Ability to work under strict deadlines PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Bachelor's Degree in a scientific field (such as Biology, Microbiology, Chemistry) Self-starter, able to work independently with minimal supervision Flexibility to adapt quickly to changing requirements from health authority guidelines and shifting submission priorities Excellent written and oral communications skills TRAVEL Willingness/Ability to travel up to 5% domestically. International travel may be required
Lundbeck LLC Deerfield, IL, USA Full-Time
Jul 10, 2018
Accounting Payroll Analyst SUMMARY: No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them. The Accounting Payroll Analyst position is responsible for multiple aspects of Payroll processing for Lundbeck NA (US and Canada). In addition to oversight of semi-monthly and special payouts, this position complete key control assessments and partners to complete internal audits to ensure accuracy. Other compliance activities include completing payroll related taxes and banking calculation/submissions, drafting written policies and procedures, maintaining auditor support documentation and assisting with 401K audit. ESSENTIAL FUNCTIONS: Processes payroll in a timely and accurate manner including special payouts such as incentives, gift reporting, expatriate payments, gross-ups, and other related activities. Analyzes all payout previews for possible errors in earnings and/or deductions. Partners with external vendor on any noted discrepancies to ensure resolution. Completes quarterly and year-end analyses to ensure government and compliance reporting is accurate and adheres to auditor requirements. Assists with accruals and payroll journal entries as necessary for proper posting in SAP. Prepares wire transfers and ACHs for payroll and related vendors including 401K, FSA, and deferred compensation, etc. Audits and reconciles payroll taxes including Forms 941, 940, and any state related taxes. Manages all correspondence and tracking of payroll tax notices including coordination with internal legal team and ADP as needed for special scenarios. Administrates the credit card system for the Lundbeck NA (US and Canada) including card setup and issue resolution with the vendor. Updates Department policies to reflect new or improved business processes including controls and workflow and leads continuous improvement efforts in the department. Supports the administration of Worker’s Compensation activities.             REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2+ years of prior payroll experience including experience with Multi-EIN payroll processing 3+ years of working with cross functional partners in a business environment Advanced Excel proficiency (sort/filter, Pivot table, and V-Look-up) Strong attention to detail and demonstrated accuracy Proven analytical skills Ability to work in a fast-paced environment and provide deliverables timely Ability to work independently, take initiative, and proactively communicate with manager and key business partners PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Fundamental Payroll Certification (FPC) or Certified Payroll Professional certification (CPP) Accredited BS degree in Business Administration or related field Internal Audit or SOX Compliance Experience Experience with SAP accounting software Experience in analyzing payroll taxes TRAVEL Willingness/Ability to travel up to 10% domestically. International travel may be required.
Lundbeck LLC Deerfield, IL, USA Full-Time
Jul 09, 2018
​ SUMMARY: No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them. The Senior Counsel position is responsible for handling a variety of substantive legal issues; providing legal, regulatory and compliance counsel to Lundbeck’s US rapidly growing business units. ESSENTIAL FUNCTIONS: Prepares, reviews and negotiates commercial agreements, 3rd party vendor agreements, service agreements, consulting agreements, corporate agreements, confidentiality agreements and clinical trial agreements. Supports marketed pharmaceutical products and products in development providing substantive advice to the Marketing, Medical Affairs and Regulatory Affairs departments and Research and Development concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, and interactions with healthcare professionals. Collaboratively resolves legal issues on cross-functional projects and communicate solutions verbally and in writing to management. Effectively communicates legal issues and risks to internal and external stakeholders regarding Lundbeck’s business and supported areas. Internally supports key stakeholders; keeping abreast of changes in laws that affect client areas. Resolves legal issues using negotiation skills and legal expertise. Serves as a resource to colleagues regarding specific areas of knowledge and foster collaborative working environment. Support the General Counsel with projects as assigned. Steps into advisory role in selective situations and assumes responsibility as need arises. REQUIRED EDUCATION, EXPERIENCE and SKILLS: JD Degree from an ABA accredited law school Admission to the Bar in Illinois or willing to be admitted to the Illinois Bar 5+ years of experience as an attorney/counsel, with at least 2 years in a Law firm supporting clients within the pharmaceutical, medical device or biotech industries Exceptional written, verbal, and presentation communication skills, including strong contract drafting skills Ability to translate legal principles to management and other line function personnel Ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees Familiarity with FDA drug and biologic law, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act, competition law and US pharmaceutical compliance program requirements PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Demonstrated experience drafting and negotiating contracts for the Life Sciences industries Litigation experience Managed care experience Experience supporting Commercial Business Advertising and Promotional Review experience TRAVEL Ability to travel up to 10% domestically. International travel is also required.
Lundbeck LLC Deerfield, IL, USA Full-Time
Jul 04, 2018
Senior Medical Science Liaison (MSL) - Neurology Territory includes Missouri, Arkansas, Louisiana, Mississippi, Oklahoma and Texas. Candidates need to reside within the territory geography with proximity / access to a major airport.                             SUMMARY:  No other global pharmaceutical company is focused solely on the brain. Lundbeck’s global legacy in neuroscience goes back seven decades, and with it comes a tremendous level of expertise, commitment and responsibility to patients. We are radically changing the future, investing in long-term plays in research. As we define tomorrow, there is no question that the here and now is critical to bridge the future. Therefore, we continue to bring forward therapies to address symptomatic improvements to help people live better lives, while simultaneously pursuing disease-modifying treatments in pursuit of a cure. Lundbeck operates within a unique corporate ownership structure: our company is 70% owned by a foundation established by the wife of our founder to ensure our continued ability to conduct difficult and time-intensive research. The Lundbeck Foundation contributes nearly $100 million to life sciences research each year and an additional 1 million euro for The Brain Prize to advance neuroscience research. The Senior MSL will apply advanced field based medical and scientific experience, subject matter knowledge, and skills in supporting medical strategies for Lundbeck compounds. Maximizes and leverages thought leader relationships by identifying mutually beneficial opportunities that meet the strategic needs of internal stakeholders. Participates in and contributes to projects and initiatives that increase the value and productivity of the MSL team and Medical Affairs. ESSENTIAL FUNCTIONS: Expands on and leverages thought leader relationships by aligning thought leader expertise with Lundbeck needs Successfully connects thought leaders internally to serve as advisors, investigators, expert guest speakers, or business development partners Executes on MSL goal and objectives and Medical Affairs product plans Applies advanced field-based medical and scientific experience, subject matter knowledge, and skills in supporting Lundbeck medical strategy Regularly collects and interprets medical insights and feedback gathered from scientific exchange with thought leaders and communicates relevent information to internal stakeholders in order to define, update, and support medical strategies Identifies and facilitates investigator initiated trials (IIT) aligned with Lundbeck's medical strategies Upon request of Clinical Affairs, assists in clinical trial support by identifying, evaluating, screening, and providing scientific support to qualified research sites Addresses unsolicited requests for medical information from health care professionals Actively participates in executing Lundbeck's strategy at scientific meetings by identifying relevant sessions, coordinating MSL meeting/booth coverage, and proactively facilitating thought leader interactions with Lundbeck stakeholders Provides ongoing scientific and medical training within the MSL team and to internal partners Provides clinical presentations and medical information to managed markets and government accounts upon request Identifies and brings forth team needs to MSL leadership Leads, actively participates in and contributes to MSL or cross-functional projects and initiatives Serves as a new hire mentor, field coach, and resource for other members of the MSL team Completes all required training, documentation, expense reporting, and other administrative responsibilities Ensures compliance with all FDA and Lundbeck requirements REQUIRED EDUCATION: Accredited advanced degree in a health sciences related field REQUIRED SKILLS AND EXPERIENCE: 5+ years of healthcare or related experience (clinical practice, research, academic, or managed markets), of which 2+ years are in the role of an MSL within a pharmaceutical company Well versed in highly technical and scientific languages in order to communicate effectively with health care professionals, researchers, and other external and internal stakeholders Firm understanding of the key phases, processes, and techniques that are involved in pre-clinical and clinical aspects of drug development Possesses superior communication skills (both oral and written), and ability to gain the trust and respect of peers, subordinates, and superiors Proven track record of teamwork, leadership, timely decision making, and results orientation in meeting objectives Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook PREFERRED EDUCATION, SKILLS AND EXPERIENCE: Accredited Masters level or Doctoral degree such as DO, MD, PA, Pharm.D., PhD, NP, or APRN Experience in various fields in CNS such as Neurology Experience in clinical practice, research, or teaching WILLINGNESS TO TRAVEL 50-75% of domestic travel; international travel may be required
Lundbeck LLC Dallas, TX, USA Full-Time
Jun 27, 2018
Medical Director, Medical Affairs Psychiatry SUMMARY: No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them. The Medical Director, Medical Affairs Psychiatry will serve as the internal medical and scientific expert for assigned psychiatry product(s), driving key medical strategies and tactics which align with Brand and Disease State strategy, building and growing strong advocacy relationships and ensure accurate, robust and appropriate medical/scientific exchange of knowledge and clinical expertise with all stakeholders in the therapeutic area, being the internal medical/scientific point-person for all other programs (Global, Clinical Development, Health Outcomes, Scientific Communications, Regulatory, Brand Teams, etc.) necessary to reach corporate objectives and goals. ESSENTIAL FUNCTIONS: Drives medical strategies (e.g., leading, developing, implementation and execution of key medical initiatives) which would align with the strategy of the Brand(s)/Disease State in the Psychiatry therapeutic area. Participates in clinical proposal process including review of proposals and protocols of approved studies while supporting Clinical Research operational and health economics/outcomes teams. Leads the assessment, selection, and implementation of funding and legal agreements for Investigator Initiated Trials (IITs). Provides US scientific and strategic input to the global Psychiatry state strategy teams. Provides US strategic input to the Lundbeck Psychiatry products clinical development plan based on the clinical and scientific knowledge and expertise and strong network in the US Psychiatry medical community. Maintains and further develops relationships and network with key opinion leaders in the psychiatric scientific community Maintains and builds productive relationships with investigators, thought leaders and centers of excellence across the psychiatric scientific community, as well as with global colleagues. Reviews business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements. Supports regulatory interactions, including the submission of regulatory documents and presentations. Serves as a medical and scientific expert, and works closely with the Pharmacovigilance group within Lundbeck US. Serves as a member of the safety committee. Participates in budgetary processes as part of annual business planning and review of expenses within US Medical. Provides medical input into Promotional Advertising Review Committee for all promotional and external materials, and participation in Labeling meetings, where appropriate, with sign-off authorization. Is involved in and develops SOPs for the activities conducted by Medical Affairs; ensuring all activities are in compliance with ICH and other international regulatory guidelines and follow relevant GCPs and SOPs. ​ REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited MD, with clinical experience in Psychiatry therapeutic area. Minimum 5 years of progressive medical/scientific affairs experience within the pharmaceutical or biotech industry, or clinical experience within academia or psychiatry practice. Ability for building partnerships and working collaboratively with others to meet shared objectives. Strong interpersonal skills to work closely with both external physicians/scientists and in-house cross-functional teams High proficiency in problem solving ability and strong scientific analytical skills Excellent planning and organization skills. Ability to maintain the highest degree of confidentiality and integrity, representing the company’s high ethics, moral behavior, and professionalism. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Specialty training in psychiatry (board certification or eligibility in psychiatry). Experience in managing and/or conducting clinical studies. Direct involvement with the FDA. Knowledge and experience in appropriate therapeutic area(s). Management and professional development of staff at several levels. Experience with copy approval and promotional review. Professional society membership(s) relevant to psychiatry. Regulatory knowledge and exposure, including experience with international regulations relating to cGCP, conduct of clinical trials overseas and demonstrated ability to manage projects internationally. TRAVEL Willingness/Ability to travel up to 30% domestically. International travel may be required.
Lundbeck LLC Deerfield, IL, USA Full-Time
Jun 21, 2018
Vice President, US Regulatory Affairs SUMMARY: No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them. The VP, US Regulatory Affairs leads both the strategic and operational aspects of Regulatory Affairs objectives for commercial products, life cycle management initiatives and acquisitions including global FDA regulatory strategy, regulatory submissions, and interaction with regulatory authorities. This role is also responsible for managing existing INDs and initiating INDs for pipeline products, subsequent FDA filings, as well as clinical trial applications and all other documentation to be compliant with all regulatory requirements. The successful candidate is the senior regulatory strategist, and is a member of the US Drug Development Senior Leadership Team as well as other global regulatory leadership and cross-functional work teams. ESSENTIAL FUNCTIONS: Strategy Provides regulatory leadership to local and global cross-functional teams through strong collaboration, ensuring perspective/expertise is incorporated in regulatory plans prior to decisions being made to secure FDA approval of new drugs and new indications for existing drugs. Directs the global team in developing, implementing and delivering a U.S. regulatory strategy for highly complex products which optimize the balance of time, cost, quality and risk to meet the needs of Lundbeck. Drives regulatory aspects of marketed product life cycle management including critical issue management and major line extensions. Presents regulatory strategies to internal governance bodies. Influences internal and external customers as necessary to ensure successful strategy implementation and in support of business marketing goals. Operations, Quality, Compliance Responsible for generating and implementing US operational regulatory practices to support document creation and submission across the company’s development and commercial product portfolio. Leads interactions with project team members, consultants, contractors and regulatory authorities to ensure regulatory paths are clearly defined and milestones are met leading to successful filings and approvals. Accountable for the timely development and submission of U.S. regulatory documents (e.g., pre-IND and end-of-phase briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory queries, IND safety reports, etc.). Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOPs. Creates and implements new SOPs as necessary to maintain regulatory compliance with new drug regulations. Provides interpretative analyses of complex regulatory guidance documents, regulations, or directives that impact the company’s products and operations and leads the response respectively. Seeks innovative and creative operational solutions that comply with regulations and are sound from business and scientific perspectives. Responsible for overall assessment of scientific data for registration purposes against regulatory requirements. Provides contingencies and alternate approaches to Senior Management and/or partners to resolve any development program challenges. Responsible for management of Regulatory Affairs budget. Communications Leads communications ensuring internal global awareness and understanding of current U.S. regulatory legislation. Monitors and communicates development of new guidelines and procedures to assess the impact and ensure compliance for product development programs. Leads response on behalf of global Lundbeck to proposed FDA regulatory policies and guidelines. Actively manages all liaisons with regulatory authorities as needed for all aspects pertaining to drug development and approval. Works closely with Alliance partners to prepare and execute U.S. development programs. Team Leadership Provides strong leadership, mentorship, training, development and ensures fit for purpose organizational design to the Regulatory team; enhancing and promoting staff growth and development. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited Advanced degree in a relevant scientific discipline 10+ years’ progressive experience in regulatory within the pharmaceutical and/or biotech industry Track record of successfully setting regulatory strategy, product registrations, and regulatory filings (e.g. IND, NDA and other similar regulatory filings) with FDA US regulatory experience Demonstrated leadership and motivation of staff to successfully execute regulatory strategies. Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems challenges Demonstrated ability to influence management, locally and globally, at all levels to support regulatory strategic and operational department needs. Highly proficient in communicating and presenting strategic and tactical issues to all levels, including top management and regulatory agencies Ability to lead and work in local and global cross-functional teams Effectively able to multi-task within assigned deadlines Previous experience leading teams with responsibility for performance management and reward planning PREFERRED EDUCATION, EXPERIENCE and SKILLS: 15+ years R&D, medical or scientific experience within the pharmaceutical and/or biotech industry. Advanced degree (e.g. PhD / Pharm D / MD) CNS experience Experience working with FDA at the policy level (e.g. influencing direction of regulatory guidance) Demonstrated ability to lead FDA strategy in global organization Due diligence / M&A experience TRAVEL Willingness/Ability to travel up to 25% domestically. International travel is required.
Lundbeck LLC Deerfield, IL, USA Full-Time