field_job_employment_type

job_industry

field_job_occupational_field_parents_all

job_organization_name

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!SUMMARY:The purpose of the Associate Director, New Product Planning is to collaborate with key US and HQ stakeholders to achieve the Focused Innovator Strategy. This includes working with US and HQ counterparts to support the acceleration and development of corporate business development initiatives and pipeline assets.&nbsp; Reporting to the Lundbeck US Vice President Strategy &amp; Portfolio Management and working closely with Director of NPP and Pricing, the successful person in this role will provide commercial assessments, input and guidance to ensure innovative, differentiated products that meet unmet patient needs and gain broad market access in highly complex and competitive markets.ESSENTIAL FUNCTIONS:&nbsp; New Product Planning Team<ul><li>Supports global New Product Planning, US Forecasting, and Business Development through the effective assessment of internal pipeline and external asset opportunities for US launch</li><li>In partnership with the Director, NPP and Pricing develops comprehensive insights into market size and opportunities, competitive overview and landscape, payer environment, unmet needs, and ongoing competitive intelligence for the disease areas in scope</li><li>Coordinating with the Director, New Product Planning and Pricing, identifies key customers, KOLs and patient advocacy organizations, and meet with them, as needed, to help assess opportunities for assigned late-stage lifecycle products.</li><li>Informs and guides market research to understand the opportunity size and market potential</li><li>Provides assessment of launch and in-market budget and promotion assumptions for opportunities to realize their potential</li><li>Collaborates cross-functionally to understand upsides and risks related to high-potential opportunities</li><li>Working with key stakeholders within Medical, Marketing, and HQ stakeholders, guide the development of launch plans for pipeline assets</li></ul>Strategic Partnerships<ul><li>Establishes and effectively collaborates with global business development, global new product planning and across US functions including Commercial, Medical and others</li><li>Partners closely with US NPP and Pricing lead to ensure pricing, market access, and GTN assumptions are taken into account for each case</li><li>Collaborate with members of the R&amp;D and Medical organization to ensure appropriate TPP development specifically clinical trial endpoints</li></ul>Cross-Functional US Teams<ul><li>To ensure stakeholder buy-in and data-driven decision making, develops and nurtures strong working relationships with a broad range of medical, marketing, market access, forecasting, finance, and business development colleagues</li><li>Provides direction as needed/requested to matrix project teams. Develops and recommends the prioritization of complex objectives</li><li>Develops and monitors metrics and key success indicators. Proactively identifies and recommends solutions to obstacles.</li></ul>REQUIRED EDUCATION, EXPERIENCE, SKILLS and COMPETENCIES:<ul><li>Accredited bachelor's degree&nbsp;</li><li>Minimum 7 years of pharmaceutical or biopharmaceutical industry experience with at least 4 years working in a Commercial organization.</li><li>Ability to coordinate and manage multiple projects simultaneously.</li><li>Proven success in developing clear, actionable steps aligned to overall business strategy</li><li>Collaborative team player with ability to build trusted partnerships, manage stakeholders and meet shared objectives</li><li>Analytical with the ability to produce actionable strategic and innovative insights</li><li>Ability to use informed, sound judgment; and make timely, effective, educated and sound decisions; at times under conditions of uncertainty</li><li>Impactful oral and written communication skills with ability to persuade and influence others</li><li>Accepts clear responsibility and accountability for results</li></ul>PREFERRED QUALIFICATIONS:<ul><li>Accredited bachelor's degree in marketing or related field or an Accredited MBA</li><li>Significant Marketing experience from that role directly or a closely affiliated role</li><li>Relevant experience within pharma (market access, business development, sales)</li><li>International/Global experience</li></ul>TRAVEL:<ul><li>Willingness/Ability to travel up to 30% domestically and internationally. #LI-LM1</li></ul>Why LundbeckLundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Lundbeck

Associate Director New Product Planning

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!Remote Opportunity - Open to candidates anywhere in the greater United States.&nbsp; Preferably East Coast or Midwest.SUMMARY:The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological products (developmental and marketed products); participates on global cross-functional teams ensuring that US requirements and expectations are achieved in an optimal and compliant manner; ensures compliance with regulatory requirements and corporate standards; maintains candid and positive communications with cross functional partners and operational support.ESSENTIAL FUNCTIONS:<ul><li>Provides regulatory review of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages, reviews and represents US regulatory perspective at Regulatory Affairs Focus Team (RAFT) meetings. Identifies risk, problem-solves, and offers solutions. Manages/supports related FDA submission activities in compliance with current regulations and guidances.</li><li>Working with US regulatory management and the Global Regulatory Lead, serves as US subject matter expert to support strategy development and execution for assigned products.</li><li>Acts as FDA contact for assigned products. Liaises with regulatory authorities for all drug development and approval aspects.</li><li>Manages the processing of regulatory submissions with Strategy leadership and operational support; ensures submissions are prepared in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.</li><li>Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives.</li><li>Assists or leads improvement efforts supporting necessary compliance enhancements and departmental efficiencies.</li><li>Manages assembly and creation of documentation supporting investigational and new drug application/biologic license application for the US FDA throughout the product’s lifecycle.</li><li>Provides high-level RA advice and identifies US regulatory requirements for clinical studies and marketing.</li><li>Assesses scientific data for proposed registration and labeling against current FDA guidance’s, regulations, and precedence.</li><li>Facilitates policy and development of standard interpretation of US regulations.</li><li>Maintains awareness of US regulatory legislation and assess its impact on business and Lundbeck product development programs.</li><li>Completes internal and external training on departmental initiatives and for compliance purposes.</li></ul>REQUIRED EDUCATION, EXPERIENCE AND SKILLS:<ul><li>Accredited Bachelor’s Degree</li><li>7+ years within the pharmaceutical and/or biotech industry&nbsp;or for a consulting company supporting the pharmaceutical and / or biotech industry</li><li>5+ years direct experience in US Regulatory Affairs</li><li>Direct experience in US drug development and regulatory submissions supporting investigational and marketing application submissions and lifecycle maintenance activities.</li><li>Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and regulations as they relate to drugs and/or biologics</li><li>Experience in identifying regulatory risk and negotiating/resolving differences</li><li>Attention to detail and strong organizational skills with the ability to meet multiple deadlines and multitask within assigned projects</li><li>Demonstrated ability to work in a multi-disciplinary, matrixed and multinational team</li><li>Excellent oral and written communication skills across all levels of the organization, including ability to articulate regulatory positions</li><li>Ability to successfully prepare and execute regulatory strategies along with providing contingencies and alternate approaches</li><li>Ability to work independently</li><li>High proficiency in MS Word, MS Excel and Adobe Acrobat and regulatory electronic document management systems</li></ul><ul><li>The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation</li></ul>PREFERRED EDUCATION, EXPERIENCE AND SKILLS:<ul><li>Accredited Bachelor’s Degree in Science, Chemistry, or Pharmacy</li><li>Advanced Degree in Science, Chemistry, Pharmacy or related subject study/experience</li><li>Experience in Biologic Development</li><li>Familiarity with Chemistry, Manufacturing and Controls requirements</li></ul>TRAVEL:<ul><li>Willingness/Ability to travel ~5% domestically to business meetings and learning experiences.</li></ul>The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $125,000 - $145,000 and eligibility for a 15% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis.&nbsp;#LI-LM1, #LI-RemoteWhy LundbeckLundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Senior Manager Regulatory Strategy - Remote Opportunity

ABOUT GREYSTARGreystar is a leading, fully integrated global real estate company offering expertise in property management, investment management, development, and construction services in institutional-quality rental housing, logistics, and life sciences sectors. Headquartered in Charleston, South Carolina, Greystar manages and operates more than $290 billion of real estate in 247 markets globally with offices throughout North America, Europe, South America, and the Asia-Pacific region. Greystar is the largest operator of apartments in the United States, manages more than 857,400 units/beds globally, and has a robust institutional investment management platform comprised of more than $76 billion of assets under management, including over $34 billion of development assets. Greystar was founded by Bob Faith in 1993 to become a provider of world-class service in the rental residential real estate business. To learn more, visit <a href="http://www.greystar.com" target="_blank">www.greystar.com</a>. JOB DESCRIPTION SUMMARYOversees and performs technical and mechanical work that ensures the inside and external buildings, grounds, amenities, and common areas of the community meet the Company’s standards for cleanliness, appearance, safety, and overall functionality.JOB DESCRIPTION<ul><li>Assists and completes work orders generated from resident requests for service, as well as routine upkeep on the community by diagnosing the source or cause of the defect or problem, and making repairs in accordance with established policies, procedures, safety standards, and code requirements.&nbsp;&nbsp; 2. Oversees and completes the “make-ready” process to prepare vacant apartment homes for leasing and new moveins by completing the pre-move-out inspection, creating a “punch” list of maintenance work needed, scheduling vendors and contractors as needed, obtaining needed supplies and materials, completing all maintenance tasks, and inspecting completed work.&nbsp;</li><li>Develops standards for the cleanliness and overall appearance of the community’s grounds, amenities, building exteriors, market ready unit interiors, breezeways, curbs, signage, leasing office, central garbage areas, parking lots, and other buildings and common areas to ensure that they reflect and represent the high quality of the community and Greystar standards.&nbsp;</li><li>Periodically inspects work performed by other service team members to assess effectiveness of policies and procedures and develop corrective action plans as needed.&nbsp;</li><li>Periodically inspects work performed by contractors, vendors and other service providers to verify the work, materials and services meet quality standards, scope and specifications as required.&nbsp;</li><li>Maintains adequate inventory of spare parts and maintenance materials and works with Community Manager to order supplies and tools as needed to stay within budgetary guidelines.&nbsp;&nbsp;&nbsp;</li><li>Completes monthly preventative maintenance procedures as outlined in the Policy and Procedure Manual.&nbsp;</li><li>Supports cost-cutting and expense control programs by fixing rather than replacing parts when possible, not being wasteful with materials and supplies, and practicing the correct use for tools and equipment.&nbsp;&nbsp;</li><li>Conducts regularly scheduled Greystar safety meetings, ensure all MSDS sheets are current and readily accessible, and keeps up to date on all OSHA and other safety related laws and requirements to ensure community compliance.</li><li>Demonstrates customer services skills by treating residents and others with respect, answering questions from team and residents, responding sensitively to complaints about maintenance services, and assigned work orders with efficiency and urgency.&nbsp;&nbsp;</li></ul>#LI-DM1Additional Compensation:<ul><li>Corporate Positions:&nbsp;In&nbsp;addition to the base salary, this role may be eligible to participate&nbsp;in&nbsp;an annual bonus program based on&nbsp;individual and company performance.</li><li>Onsite Property Positions:&nbsp;In&nbsp;addition to the base salary, this role may be eligible to participate&nbsp;in weekly, monthly, and/or quarterly bonus programs.</li></ul>Robust Benefits Offered*:<ul><li>Competitive Medical, Dental, Vision, and Disability &amp; Life&nbsp;insurance benefits. Low (free basic) employee Medical costs for employee-only coverage; costs discounted after 3 and 5 years of service.</li><li>Generous Paid Time off. All new hires start with 15 days of vacation, 4 personal days, 10 sick days, and 10 paid holidays. Plus your birthday off after 1 year of service! Additional vacation accrued with tenure.</li><li>For onsite team members, onsite housing discount at Greystar-managed communities are available subject to discount and unit availability.</li><li>6-Week Paid Sabbatical after 10 years of service (and every 5 years thereafter).</li><li>401(k) with Company Match up to 6% of pay after 6 months of service.</li><li>Paid Parental Leave and lifetime Fertility Benefit reimbursement up to $10,000 (includes adoption or surrogacy).</li><li>Employee Assistance Program.</li><li>Critical Illness, Accident, Hospital&nbsp;Indemnity, Pet&nbsp;Insurance and Legal Plans.</li><li>Charitable giving program and benefits.</li></ul>*Benefits offered for full-time employees. For Union and Prevailing Wage roles, compensation and benefits may vary from the listed&nbsp;information above due to Collective Bargaining Agreements and/or local governing authority.Greystar will consider for employment qualified applicants with arrest and conviction records.

4 Procurement / Operations Jobs in Libertyville, IL, USA