Senior Manager, Regulatory Strategy

Senior Manager, Regulatory Strategy

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, Alzheimers disease and Parkinsons 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 isnt 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, Regulatory Strategy: works independently with minimal management oversight on novel regulatory strategy development and IND and NDA registrations for multiple drug development programs; serves as the regulatory strategist in development and implementation of regulatory strategies to support drug development programs; and works with cross functional teams and global RA counterparts to ensure regional requirements and commercial expectations are achieved while ensuring compliance with applicable regulations.

ESSENTIAL FUNCTIONS
* US Regulatory Lead for multiple drug development programs, working with Global Regulatory Lead to provide US regulatory strategic and operational input to cross functional development teams
* Key member of marketed product team developing and implementing the regulatory strategies, such as developing life-cycle product development, PRM compliance, CMC changes, label revision, and safety reports
* Coordinates meetings between FDA and Lundbeck by drafting meeting requests, reviewing briefing materials, and assisting on the formal FDA meeting preparations
* Serves as Lundbeck US Regulatory representative to support Lundbecks alliance projects, including regulatory strategy development, contributions to submission documentation, and to coordination of feedback from internal subject matter experts and commercial stakeholders
* Manages compilation of regulatory documentation for responsible INDs or NDA. Ensures assigned US drug applications are compliant with all current regulations by reviewing all Regulatory dossiers for completeness and accuracy prior to submission.
* Liaises with FDA to coordinate the correspondences between the Agency and Lundbeck on new clinical study proposals and Life Cycle Management initiatives
* Maintains awareness of global Regulatory legislation and assess its impact on business and Lundbeck product development programs
* Works independently with minimal oversight from Senior RA management to develop creative solutions to unusually complicated Regulatory and systems problems

REQUIRED EDUCATION, EXPERIENCE and SKILLS:
* Accredited Masters degree or higher
* 6+ years of Pharmaceutical Industry experience
* 4+ years Regulatory Affairs experience
* Experience as the direct FDA liaison for marketed product and/or development programs

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
* Additional degree(s) or certifications
* NDA and IND filing experience

TRAVEL
* Willingness/Ability to travel up to 10% domestically. International travel may be required on occasion

Junior Business Analyst

Job Title: Business System Analyst Order to Cash

Location: Deerfield, IL

Type: Contract to Hire

Job Summary:

The Business System Analyst will review, analyze and evaluate business processes and user needs.
The incumbent performs functional analysis, requirements definition, SAP system configuration and testing in Sales and Distribution and Materials Management areas.
The role will document requirements, write test & execute test scripts and help generate data using SQL querying skills for additional reporting tools.

Job Responsibilities:

1.Demonstrate functional knowledge in Order to Cash and Procure to Pay Processes to advise business users on day-to-day production incidents and minor enhancement projects

2.Understanding on basic SAP system configuration of sales and supply chain processes.

3.Understand SAP’s master data integrity, information flow processes, Data querying and preparation (simple table join architecture)

4.Communicates and collaborates with external/internal customers and stakeholders to analyze information and business needs to deliver functional and technical requirements to applications development teams along with business solutions to the company

5.Identifies business process requirements and articulate the same to the system solutions

6.Responsible for test data creation, test execution and coordinating the change management process for production migration

7.Elicits requirements using interviews, document analysis, requirements workshops, surveys, site visits, business process descriptions, use cases, scenarios, data and workflow analysis

8.Assists in security/ authorization set-up, user documentation, data interface design, data migration and reconciliation

9.Ensures that all deliverables are completed in accordance with Project Management direction; clearly and frequently communicate the status

10.Investigates processes and identify root cause problems

11.Collaborates with other cross functional business analysts and subject matter experts to establish the technical vision and analyze tradeoffs between usability and performance needs

12.Acts as the liaison between the business units, technology teams and support teams

Minimum Qualifications:

1.Bachelors degree in Computer Science, Information Systems or another related field

2.Related experience with applications development experience preferred.

3.SQL knowledge is preferred

4.Ability to work effectively with all levels of management in a deadline-oriented environment

5.Excellent oral and written communication skills with organization and time management skills

6.Ability to learn, demonstrate and apply knowledge of the business over to solutions and processes

7.1-3 years of related SAP ECC experience ( ECC 6.0 or higher) with emphasis on OTC and P2P processes

8.Good understanding of the SAP OTC and P2P processes including Contract and Sales Order management, Delivery shipment, Pricing, Invoicing, Text and Output determination, Purchase order management with end to end GR/IR processes, Intercompany & Intracompany transfers and third party drop shipment special process

9.Basic cross-functional integration knowledge in FI/CO, SD, MM and PP modules is a plus

10.Knowledge in setting up EDI configuration and providing system integration solutions is a plus

11.Experience with Agile methodology is preferred

12.Legally eligible to be employed in the United States

Integrations Developer: II

JOB TITLE: Integrations Developer: II (Intermediate)

JOB LOCATION: Deerfield, IL

JOB SUMMARY: The Workday Integrations Specialist will be part of the HRIT team and will be primarily responsible for maintaining existing Workday integrations as well as developing new integrations as we implement new/additional modules within Workday.
We are looking for a skilled Workday Integration developer who has excellent design and programming skills. You should enjoy working with a talented team of individuals, with diverse skills and experiences, who strive to excel in delivering software solutions that help enable the organization accomplish their objectives and goals.

JOB RESPONSIBILITIES:
* Design, develop, implement, and maintain Workday integrations with third party vendors.
* Ability to quickly adapt to new technology and platforms.
* Tests and debugs programs to finalize and ensure smooth operation.
* Documents program design, coding and other details to guide others in application development, use and maintenance.
* Demonstrate a high level of quality, speed, reliability and efficiency while being able to work independently.
* Work closely together with other team members and proactively share expertise to ensure the team success.
* Ability to establish / maintain credibility and collaborative relationship with the business and functional resources.

MINIMUM QUALIFICATIONS:

* Bachelors Degree in Computer Science required or equivalent technical training and work experience.
* 4+ years experience in software development, 2-year experience in Workday Integration

* Strong communication skills, both verbal and written.
* Strong analytical and problem solving skills.
* Ability to work independently and in teams.
* Understanding of procedural and object oriented design.
* Design, implement, and deploy integration solutions to the Workday cloud.
* Have functional understanding of processes like Organizations, Staffing Models and Business process flow of HCM System
* Worked on Enterprise Interface Builder for both Inbound and Outbound integrations.
* Worked on Workday Studio to build sophisticated integrations to and from Workday.
* Utilize the Connectors and Cloud Connect Packages to integrate with third-party applications.
* Worked on Document Transformation, Simple and fixed length XSLT.
* EIBs (Inbound, outbound), Core Connectors and Cloud Connect
* Experience with version control (Git/CVS)
* Understanding of application server technologies
* Familiarity with applications development process.
* Ability to effectively articulate and present complex concepts and ideas to seniors, functional and business teams.
* Legally Eligible to work in the United States