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

Region Manager

Safety, Customers, People, Community & Excellence

A leading provider of student transportation, National Express LLC (NELLC) is the North American subsidiary of National Express Group, one of the premier transportation firms in the United Kingdom. NELLC operates 250 branches in North America, employs 30,000 individuals and has revenues of $1.2B. National Express consists of Durham School Services, Septran, Petermann Bus, The Provider, Safeway, Smith Bus and TransExpress in the Unites States and Stock Transportation in Canada. As a leader in student transportation, National Express, LLC (NELLC) is committed to exceptional safety, outstanding customer service and positive employee relations. We are currently seeking a Region Manager to oversee a number of our Customer Service Centers (CSC) in the Eastern Pennsylvania Area.

Responsibilities:
* Coaching and advising General Managers
* Identifying growth opportunities and working collaboratively with Business Development
* Building and maintaining strong business relationships with identified customer base
* Ensuring General Managers have significant customer relationships throughout their district
* Identifying, tracking, and addressing customer trends
* Defining the behavior of competitors in the region
* Understanding customer contracts and compliance
* Developing well-formed strategies and tactics for contract negotiations
* Interpreting the meaning of the customer/competitor/industry trends for the region team
* Monitoring business results; ensuring the region is meeting all contract responsibilities
* Ensuring the area has a solid business plan and budget
* Working with General Managers to make sure they know how to read relevant financial statements
* Tracking region and CSC results, defining trends, and anticipating impacts
* Reviewing financial statements for the region, analyzing them, and developing action plans
* Ensuring General Managers develop appropriate improvement plans
* Working with General Managers to make sure employee relations plans are in place and well executed
* Ensuring process, policy and initiative compliance; ensuring business tools are being used
* Working with General Managers to ensure consistent implementation processes; explaining the value of consistency
* Reviewing talent management plans; ensuring that talent within the area is identified and developed
* Confirming General Managers have coaching plans and coaching notes for the members of the CSC staff
* Ensuring General Managers and staff attend workshops, seminars, and learning events
* Identifying and providing opportunities for General Managers to participate in policy, process, and program design meetings as well as project teams
* Other duties assigned to meet the needs of the business
* Conduct special projects as requested by the Vice President, Operations

* Bachelor’s Degree required; a focus in Business Management, Accounting or Economics preferred
* 10 or more years of experience in an operations management role; 5 or more years in a senior manager role
* Experience supporting multiple sites/branches/locations; ability to provide guidance and management from a remote location
* Proven leadership ability, industry-specific knowledge gained through experience
* Strong negotiation skills and techniques
* Desire to coach and mentor others
* Financial acumen and knowledge of economic theory
* Practical application of marketing and sales theory and principles
* Comprehensive understanding of labor and employment practices law
* Working knowledge of Microsoft Office software (Word, Excel, Outlook, PowerPoint, etc.) and accounting-based systems
* Excellent verbal and written communication skills along with strong interpersonal skills
* Strong analytical skills with an attention to detail
* Creative, innovative, and flexible mindset
* Ability to work independently or as part of a team
* Well-developed time-management skills
* Utmost professionalism, integrity, and confidentiality
* Must have the ability to travel up to 50%

National Express LLC is an Equal Opportunity Employer

For more information please visit http://www.nellc.com

Analyst, Sr Associate (S,R&C)

Analyst, Senior Associate

Job Description:

The Credit Risk Management Unit in Supervision, Regulation, and Credit of the Federal Reserve Bank of Boston has an opening for a Senior Associate Analyst to contribute to its Discount Window and Payment System Risk (PSR) activities. Staff in this position is responsible for supporting the day-to-day operations of the Discount Window and depository institution account management, performing a wide variety of duties involving the analysis and processing of data, review of processes and procedures, and contributing to other ad hoc initiatives, as needed. Senior Associate Analysts follow established guidelines with general oversight to perform these duties. Staff in this position is expected to identify and resolve related operational and analytical problems independently. They are expected to have broad working knowledge within their functional area, and are expected to support the routine analytical work of more senior staff as needed.

Principal Accountabilities :

Handle all workflows and communications for the most complex processing activities associated with collateral management, Discount Window lending, and depository institution account management, elevating issues as appropriate.

Monitor discount window borrowers and FRB account activity and recommend appropriate action based on policy parameters.

Support databases and create queries in support of Discount Window, PSR, collateral, or condition monitoring functions.

With guidance, administer the seasonal borrowing program, including conducting analysis and offering recommendations for management approval, coordinating related communications, and monitoring ongoing compliance with policy guidelines.

Monitor DI status in meeting Borrower In Custody program requirements and in ongoing adherence to policies, and participate in on-site inspections of BIC program participants, as requested.

With guidance, prepare reports and analyses for unit management, as well as Credit and Risk Management and Board of Directors meetings, and conduct basic acceptance review of pledged assets.

Under the direction of more senior staff, support the administration of continuous Condition Monitoring of district institutions, including analysis of appropriate risk controls, drafting of correspondence, tracking information flows and preparation of management reports.

Provide analytical and research support for ad hoc assignments of modest complexity.

MINIMUM QUALIFICATIONS AND ANY SPECIAL REQUIREMENTS:

Knowledge and experience normally acquired through, or equivalent to, the completion of a Bachelor’s degree in a related field and a minimum of 5 years of job-related experience.
Staff in this position is expected to possess the following essential skills:
Required

Continuously expanding knowledge in area of expertise, identifying the implications of, and responses to, changing business conditions, and developing effective approaches to operational problems.

Ability to manage time and multi-task to meet daily work stream demands.

Effective team player.
Highly Desirable

Demonstrated oral and written communications skills, including ability to develop tailored, concise, and effective oral and written correspondence for both internal and external audiences

Understanding functional area data sources and competently using established tools, Microsoft Excel, and other advanced tools as appropriate to analyze the information.

This position requires access to confidential supervisory information, access to which is limited to “Protected Individuals” as defined by regulation of the Board of Governors of the Federal Reserve System. Protected Individuals include, but are not limited to, U.S. citizens, U.S. nationals, and lawful permanent resident aliens (also known as “green card holders”) who are eligible for and seeking United States citizenship within the requisite timeframes.

All employees assigned to this position will be subject to FBI fingerprint/ criminal background and Patriot Act/ Office of Foreign Assets Control (OFAC) watch list checks at least once every five years.

The above statements are intended to describe the general nature and level of work required of this position. They are not intended to be an exhaustive list of all duties, responsibilities or skills associated with this position or the personnel so classified.

While this job description is intended to be an accurate reflection of this position, management reserves the right to revise this or any job description at its discretion at any time.

Lead Admin

JOB REQUISITION
Lead Admin

LOCATION
GA SAVANNAH

JOB DESCRIPTION

Job Summary

As Lead Administrator I, your specific responsibilities will include:
* Act as the primary support person for 4-8 Staffing Professionals.
* Taking candidate calls, reviewing resumes, scheduling interviews, sending letters acknowledging application/interview, entering candidate information into MicroJ, run MicroJ sales reports, order business cards and marketing material, etc.
* Provide primary support to the Branch Manager and District Office. This would include processing all expense reports, A/P and internal staff payroll forms.
* Act as the point of contact for the Regional Manager, Branch Manager, District Administrative Coordinators and District Operations Specialists.
* Receive all vendor calls and handle appropriately.
* Act as a point of contact for property management issues. (May not be able to handle all issues, but can escalate appropriately)
* Keep an inventory of all office supplies, office equipment and postage. Order additional supplies as required.
* Act as the project liaison for all district or corporate initiated projects.
* Distribute information, as assigned, to the Staffing Professionals. This would include, but not limited to, corporate roll-out information, branch scorecard information, reports per Branch Managers request, and CTO reports etc.
* Work with Branch Management to plan branch functions (e.g., meetings, open houses, parties, etc.).

Qualifications:
* 1+ years college required or equivalent experience.
* 3+ years administrative experience in an office environment with heavy customer contact.
* General knowledge of Microsoft Office products and database entry.

Top Reasons to Work for Robert Half:

* EXCITING CAREER OPPORTUNITIES WITH THE INDUSTRY LEADER Our more than 65-year history of success and strong client relationships provide a level of stability few companies can match.
* PERFORMANCE = REWARD We offer exceptional earning potential and a competitive benefits package, including a base salary and monthly performance-based bonuses, paid time off as well as group health, life and disability insurance, and a 401(k) or deferred compensation plan. ·
* UPWARD MOBILITY With more than 330 locations worldwide, we provide excellent career advancement potential, both locally and beyond.
* TOOLS FOR SUCCESS We provide world-class training, client relationship management tools and advanced technology to help you succeed.
* RESPECTED WORLDWIDE Robert Half once again was named first in our industry on
Fortune® magazines list of World’s Most Admired Companies. (March 1, 2017)

You may submit your application materials online or call 1.888.400.7474 for additional ways to apply.
Robert Half International Inc. is an Equal Opportunity Employer. M/F/Disability/Vet

JOB LOCATION
GA SAVANNAH

Operations Clerk 1

Print Bindery Job Instructions, make copies and assemble in applicable job jacket. Process and print CLF Tags, print batch files. Work closely with Customer Service to ensure all job instructions/material/labels are available per the Daily Production Schedule.

Print paper mail label pads and assemble with pallet placards. Assemble inkjet pallet placards. Print carton and shipping order labels and place in appropriate job jacket(s). Place all job materials in appropriate job bin(s). Provide training to potential Bindery Services “fill-in” employees. Maintain supply inventory and place orders. Maintain Bindery Quality Alert Shared Folder. Maintain inventory on parts needed for Bindery Services office equipment (SATO). Perform other miscellaneous duties assigned by supervisor.

High School Diploma or equivalent required. Must have good clerical skills to include; ability to read and interpret data and draw valid conclusions, good verbal and written communication skills, experience using email programs and general computer skills. Strong organizational skills and good attention to detail are a must.

Part-Time Retail Sales Associate #258 – up to $14/hr+ $300 Hiring Bonus

Overview:
* As an Omaha Steaks Retail Sales Associate, you are responsible for building rapport and selling our gourmet products.
* Our store employees are traditionally enthusiastic individuals who believe in our brand, customer service and team work.
* We provide advanced training that will help you excel in this position and prepare you for future growth opportunities at Omaha Steaks.

Benefits:
* Monthly sales incentives and bonus potential.
* Generous product discounts. Purchase our products at substantial discounts off regular prices.
* Educational Assistance. Receive reimbursement for tuition expenses with a minimum of 20 hours a week.
* Paid time off.
* 401k retirement plan with company match.
* Annual company bonus program.

Responsibilities:
* Develop an exceptional familiarity of the Omaha Steaks brand and comprehensive product knowledge.
* Understand that the guest is the center of what we do.
* Work to achieve the highest level of guest satisfaction and sales objectives.
* Operate the retail cash register system. Captures proper sales information for all transactions.
* Open and/or close the store, may include counting cash, nightly deposit or securing the store.
* Stock freezer, perform physical inventory and follow all inventory procedures.

Qualifications:
* Must be at least 18 years of age.
* High school diploma or equivalent.
* Excellent customer service and communication skills.
* Retail sales experience preferred, but not required.
* Must be able to enter data quickly and efficiently with keyboarding skills.

Schedule Requirements:
* Store Hours: Monday through Saturday 10am – 8pm & Sunday 10am – 6pm. The schedule will vary based on store needs.

Special Note:
* Military Veterans and their spouses are encouraged to apply.

Please address inquiries to:
* [Apply online]

Host/Hostess – Stan Diego Baja Taco Kitchen

Stan Diego Baja Taco Kitchen

Join our growing family and live the taco dream. Apply today.

OUR IDEAL CANDIDATE:

We are looking for a someone with a friendly personality who takes pride in their work and appearance and actively contributes to a positive workplace culture. The success of our restaurant is built upon our 5 core values and we find our happiest employees share those values. To be successful in this role, you will need to have strong customer service skills and the ability to hold your composure with a smile during the busy dining rush hours. If this sounds like you, and you have the education and experience listed below, we would love for you to apply!

___________________________________

POSITION SUMMARY

Job Title: Host/Hostess

Reports to: Dining Room Manager

Education: High School Diploma or equivalent experience desirable

Experience: Host/Greeter or customer service experience in a restaurant or retail work environment preferred

ESSENTIAL DUTIES:
* Greet guests positively, as a representation of their first interaction with the restaurant.
* Determine seating capacity guests require for their party size and accommodate any special arrangements. Provide guests with a wait time determined by the number of tables that will soon become available.
* Properly seat guests in by rotating between various sections to ensure servers can provide fast and friendly customer service to each guest.
* Organize food menus, LTO menus, kids menus, and other promotional material and ensure they are properly distributed to each guest.
* Taking reservations over the phone, and making sure all arrangements are documented with the guests name, phone number, number of people expected, and time of arrival.
* Continually conduct secondary work during times where the restaurant is not as busy (i.e. sweeping entrance area, washing windows, wiping down childrens booster seats, and assisting servers.

WORKING CONDITIONS:

This role will require some physical demand including standing, walking, bending, and lifting/carrying up to 25lbs.
Working in the front of the house at the front entrance of the restaurant in a moderately controlled environment, interacting with customers.

WHY WORK WITH US?

While the work at times might be demanding, we do our best to foster a positive work culture and work/life balance.
We understand we too have to earn your loyalty and are always improving our business practices to stay competitive in the industry so we can offer job security and an awesome place to work.
We hope to achieve this by providing you with the right training tools and a supportive workplace where you can take charge of your career development with the opportunity to make good money and grow within our organization.
We also offer competitive pay, flexible schedules, meal discounts, benefits for our full-time team members, and management opportunities within a multi-unit hospitality group!

Westborough Robert Half Finance and Accounting Recruiting Manager

JOB REQUISITION
Westborough Robert Half Finance and Accounting Recruiting Manager

LOCATION
MA WESTBOROUGH

JOB DESCRIPTION

Job Summary

As Recruiting Manager your responsibilities will include developing and growing a client base and new business opportunities, introducing our services via telephone and in-person meetings with new and existing clients to expand the utilization of our services. Recruiting, evaluating and placing finance and accounting professionals in full-time positions with our clients. Delivering outstanding customer service to both clients and candidates. Providing consistent communication and career guidance to candidates. Participating in industry trade associations to increase our presence within the local finance and accounting community.

Qualifications:
* A business related degree, ideally in finance or accounting. CPA and/or MBA a plus.
* 2+ years of experience in public/industry accounting/finance and/or successful permanent placement recruiting experience required.
* Successful candidates will have a proven track record of success, excellent communication skills and a high sense of urgency.
* The ability to leverage finance and accounting experience to manage and grow the business.

Are you looking for an exciting new opportunity with exceptional earning potential? If you are seeking a rewarding, challenging and dynamic environment, we invite you to apply today!

Top Reasons to Work for Robert Half:

* EXCITING CAREER OPPORTUNITIES WITH THE INDUSTRY LEADER Our more than 65-year history of success and strong client relationships provide a level of stability few companies can match.
* PERFORMANCE = REWARD We offer exceptional earning potential and a competitive benefits package, including a base salary and monthly performance-based bonuses, paid time off as well as group health, life and disability insurance, and a 401(k) or deferred compensation plan. ·
* UPWARD MOBILITY With more than 330 locations worldwide, we provide excellent career advancement potential, both locally and beyond.
* TOOLS FOR SUCCESS We provide world-class training, client relationship management tools and advanced technology to help you succeed.
* RESPECTED WORLDWIDE Robert Half once again was named first in our industry on
Fortune® magazines list of World’s Most Admired Companies. (March 1, 2017)

You may submit your application materials online or call 1.888.400.7474 for additional ways to apply.
Robert Half International Inc. is an Equal Opportunity Employer. M/F/Disability/Vet

JOB LOCATION
MA WESTBOROUGH

Material Handler

Before you begin, please note special application instructions below.

Application Instructions:

* Click the link below to complete our pre-employment assessment (approximately 30 minutes or less).
+ http://www.ondemandassessment.com/verify/apply/ABRSRBy/hDCwPhha

* After completing the pre-employment assessment, come back to this job posting and click the Apply button to complete our online application where you can also submit a resume.

After completing your online application, your pre-employment assessment results and application/resume will be more thoroughly reviewed and you may be contacted for a personal interview.

Morgan Corporation is the largest manufacturer of medium duty freight van bodies and refrigerated truck bodies in the U.S.
Joining the Morgan team means being part of a growing company with huge rewards for your career.
We pride ourselves in team member development, performance recognition and a culture of diversity and respect.

Essential Job Functions:
* Work and adhere to all safety policies within the work area and throughout the company.
* Properly and safely operate required tools both power/non-power.
* Understand and comprehend measurements and have the ability to apply based on instruction.
Ability to read a tape measurer.
* Fully understand quality policies and have minimum or zero defects per unit.
* Ability to read and or interpret work orders and apply to task at hand.
* Team member actively participates and supports PPS, 5S and TPM.
* Perform task within allotted RE time.
* Flex within functional areas as needed.
* Work required schedule including overtime.
* Assist with on the job training of team members.
* Work with little or no supervision.
* Meet physical requirements which include lifting up to 35lbs, standing for long periods, bending, stooping, reaching and squatting.
* Perform other duties as required by management.

Specific Job Functions :
* Safely operate forklift/straddle lift within areas of the facility

* Complete daily forklift/straddle lift inspection sheet.
* Computer literate – required to learn the AS/400 system.
* Utilize transaction control sheet
* Ability to safely perform the following:

* Roof Coil change out
* Door Rack change out

Use of Banding Equipment

Ability to properly identify part numbers.

Comply with truck and trailer safety.

Proper handling of all products/parts to include but not limited to customer units including flat-bed carry out, FRP’s, and hazardous materials.

Qualifications:
* High School Diploma or equivalent GED preferred.
* Prior forklift experience preferred.

PHYSICAL REQUIREMENTS:

This job operates in a manufacturing plant environment. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand (sometimes for extended periods); walk; use hands to finger, handle or feel; and reach with hands and arms, and lift up to 35 pounds. The employee may, at times, sit, bend, stoop, squat, reach overhead, or crawl (may be in confined spaces). The employee is expected to perform repetitive tasks using their hands, and have the ability to climb ladders and/or work in high places.

Recruiting Manager, The Creative Group – Charlotte

JOB REQUISITION
Recruiting Manager, The Creative Group – Charlotte

LOCATION
NC CHARLOTTE

JOB DESCRIPTION

Job Summary

As a Senior Creative Recruiter, your responsibilities will include:
* Utilize numerous networking tools to develop and grow a candidate talent base for creative and marketing projects and interim staffing solutions.
* Quickly source, recruit, interview and match highly skilled creative professionals to clients creative needs using our internal database, job boards, social networking and portfolio sites, etc.
* Connect with people in-person, by phone, and using various digital methods to establish strong business relationships.
* Responsible for solidifying The Creative Groups brand and presence in the local marketplace through consistent participation in networking organizations, trade association events, local user groups, and alliance meetings and events.
* Deliver the highest level of quality customer care and service.
* Partner closely with Recruiters and cross-functional teammates to accomplish daily business growth and placement goals.
* Work in a collaborative team environment while being accountable for individual goals.
* Take incoming phone and online inquiries from clients and candidates as required.
* Contact with all managerial levels to determine candidates fit for the assignment and viability to support specific client needs.
* Strategize with teammates to accomplish daily business growth and placement goals.
* Reports to the Division Director.

Qualifications:
* Candidates for this role must be able to demonstrate excellent business development, negotiation, communication and problem-solving skills in a fast-paced business environment.
* Minimum 3+ years experience in one of the following practice areas: marketing, branding, advertising, public relations, creative design, or multimedia.
* Ability to discern creative ability in both design and copy practices also is required.

Top Reasons to Work for Robert Half:

* EXCITING CAREER OPPORTUNITIES WITH THE INDUSTRY LEADER Our more than 65-year history of success and strong client relationships provide a level of stability few companies can match.
* PERFORMANCE = REWARD We offer exceptional earning potential and a competitive benefits package, including a base salary and monthly performance-based bonuses, paid time off as well as group health, life and disability insurance, and a 401(k) or deferred compensation plan. ·
* UPWARD MOBILITY With more than 330 locations worldwide, we provide excellent career advancement potential, both locally and beyond.
* TOOLS FOR SUCCESS We provide world-class training, client relationship management tools and advanced technology to help you succeed.
* RESPECTED WORLDWIDE Robert Half once again was named first in our industry on
Fortune® magazines list of World’s Most Admired Companies. (March 1, 2017)

You may submit your application materials online or call 1.888.400.7474 for additional ways to apply.
Robert Half International Inc. is an Equal Opportunity Employer. M/F/Disability/Vet

JOB LOCATION
NC CHARLOTTE