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Associate Director, Regulatory Affairs CMC
Job Summary: We currentl... Other Details.

Job Summary:

We currently have an opening for a Associate Director, Regulatory Affairs-CMC in our Edison, New Jersey location. This person provides regulatory guidance and strategy to Integrated Project Teams (IPT’s) and other functional teams leading to sound scientific development programs and successful registration for new compounds and new indications. Represent Sankyo during FDA interactions; able to schedule and lead meetings with FDA and prepare company personnel for FDA interactions. Determine the content for regulatory submissions as well as evaluate submissions for accuracy. Prepare regulatory responses to requests from health authorities. Direct preparation of annual reports for both marketed and developmental products..

Responsibilities:

You will organize and manage the preparation (content and format) of all types of submissions to FDA. Coordinates activities required for timely and accurate reporting of information to existing submissions.

Facilitate and support liaison activities with functional groups within Daiichi Sankyo Pharma Development and Corporate partners related to assigned products/project areas.

Provide regulatory support and guidance and manage regulatory submissions

Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations. Promotes global RACMC services to CMC Operations, Pharmaceutical Development, and Clinical Supplies’ Operations within the organization.

Supervise the identification and compilation of required documentation for submission. Prioritizes workload.

Evaluate content and adequacy of submissions and identify deficiencies.

Education/Experience

Qualified candidates will have a Bachelors degree in Life Sciences; MS/Pharmacy Degree is a plus.

10+ years in the pharmaceutical industry with significant experience in scientific/regulatory fields. Experience in international Regulatory Affairs – CMC is a plus.

Excellent interpersonal skills; ability to work across functions in a multinational/diverse, matrix organization to accomplish results. Be “detailed-oriented”; well-organized and self motivated; demonstrated excellent written and oral communication skills. Ability to make effective presentations at all levels is critical.
Experience filing NDA’s, IND’s as well as SUPAC supplements and amendments and annual reports. Understanding of drug development and regulatory processes. Knowledge of regulatory principles. Ability to interact effectively with FDA. Proven ability to manage multiple, complex regulatory projects.

Packaging Line Mechanic
Job Summary: We currentl... Other Details.

Job Summary:

We currently have an opening for a Packaging Line Mechanic, in our Bethlehem, Pennsylvania location. This position will be responsible for production equipment set-up, resulting equipment operation/performance and general equipment reliability and upkeep. The incumbent will also troubleshoot, diagnose and repair machine breakdowns in conjunction with maintenance and engineering personnel.

Responsibilities:

In this role, you will prepare tooling and ancillary equipment for production runs and ensure line and equipment changeover is done in a timely and effective manner; facilitate fine-tuning and optimization of equipment operation; devise and execute equipment/machine preventative maintenance procedures as required in a current Good Manufacturing Procedure (cGMP) environment; provide input on new equipment purchases to ensure proper functionality and ease of set up; and direct and implement continuous improvement ideas through review of standard operating conditions and problem-solving process

Education/Experience
Qualified candidates must have a High School diploma/ Technical School or equivalent and minimum 5 years of experience in the pharmaceutical, cosmetic or packaging industry as a Packaging Line, set-up or lead mechanic. Associates Degree in Electromechanical Technology or equivalent certification is preferred. Trade certification is preferred. Experience in using PLC, electronic key pad controls, hydraulics, pneumatics is required. General technical expertise with electro-mechanical systems and PLC-driven machinery; and thorough knowledge of various packaging machines including FFS, bottle-filling (solid dose), over-wrapping, blistering, card sealing, cartoning and liquid/powder filling is required. Knowledge of industrial trades and manufacturing equipment industry with specific knowledge in healthcare/food packaging or related industries; Six SIGMA or CIP (Continuous Improvement Process) are critical skills in this role. Employee must be able to gown and work in protective gear as required by SOP. The physical requirements of this job are excellent color vision 75% of time; ability to lift a minimum of 50 lbs. 20% of time; excellent dexterity (ability to use hand tools) 90% of time; ability to stand and or kneel 75% of time; ability to climb a ladder 25% of time; and ability to Bend, Reach, Stretch and work in Tight Spaces 50% of time.

Sales Representative, Primary Care Sales - Cleveland South, OH 2
Job Summary: Calls on he... Other Details.

Job Summary:

Calls on health care professionals in assigned sales territory and communicates product advantages, features and benefits, plays a vital role in fostering the Company’s reputation and image. Is responsible for selling and promoting Daiichi Sankyo products in a highly professional, ethical and knowledgeable manner.

Requirements:

Achieves or exceeds sales objectives in assigned territory.

Builds relationships with physicians and key thought leaders and influencing physicians and healthcare providers to prescribe Daiichi Sankyo promoted products. Analyzes customer needs and interests. Complies with applicable laws in providing physicians with pharmaceutical samples and literature. Represents the Company in a highly professional and ethical manner, and fosters the Company’s reputation and image. Continually enhances product and disease state knowledge by participating in assigned training and completing outside reading. Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. Carries out all sales and marketing programs including occasional evening and weekend events in the approved manner. Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Transports materials (samples, visual aids, audio visual and other electronic equipment) up to 25 pounds into physician’s office.

Education and Experience Requirements:

BS/BA. Sales experience preferred.

Daiichi Sankyo offers our employees a unique culture and broad career opportunities for both lateral and promotional movement within the company. We encourage our employees to take on new responsibilities, share their ideas, and contribute innovative solutions to help the company achieve its goals and objectives.

DSI generates a culture of high performance and excellence by offering our employees professional development tools and resources. We also offer a diverse menu of professional training and rewards, and recognition programs that reinforce the value of a job well done.

Sales You're a leader; you thrive on building relationships grounded through collaboration and teamwork and you operate with the highest level of integrity... explore an exciting career in pharmaceutical sales. We offer benefits that reflect our respect for you, your work, and your family life. Our compensation programs are competitive and reward top performance and dedication. Search for Sales Rep jobs >> Search for positions in Sales Training >> Search for all Sales Opportunities >>	Research and Development Our scientific community possesses a passion for science that leads to the development of innovative, best-in-class pharmaceutical products. We offer benefits that reflect our respect for you, your work, and your family life. Our compensation programs are competitive and reward top performance and dedication. Search for jobs in Research and Development >>	Marketing Help develop and execute strategies that maximizes the commercial potential of our pipeline and successfully launch our products. Search for jobs in Marketing >>
Medical Affairs Critical to the success of our company is the role Medical Affairs employees have in providing the medical and scientific support to the commercial organization for our marketed and pipeline products. Search for jobs in Medical Affairs >>	Information Technology Drive the company's business objectives with your expertise in enterprise architecture, information technology, information services, project management and SAP and related business applications. We offer benefits that reflect our respect for you, your work, and your family life. Our compensation programs are competitive and reward top performance and dedication. Search for jobs in Information Technology >>	New Product Planning In partnership with other departments, you will help the New Product Planning team develop U.S. and global pre-commercialization strategies and plans in support of late-stage products, as well as evaluate and develop new products to ensure DSI maintains and continues to build a strong portfolio and pipeline of products. Search for jobs in New Product Planning >>
Managed Markets Managed care continues to evolve as a central part of the process of delivering health care to patients. In collaboration with other internal and external partners, develop and execute the strategies to engage with the diverse world of payers that collectively control reimbursement for DSI product use. Search for jobs in Managed Markets >>	Legal & Government Affairs Provide legal support and guidance for all of DSI to align our business strategy with our core values. Government Affairs builds strong relationships with all our partners at the local, state and federal levels to represent DSI's position relative to legislation that affects the pharmaceutical industry and care to our patients. We offer benefits that reflect our respect for you, your work, and your family life. Our compensation programs are competitive and reward top performance and dedication. Search for jobs in Legal & Government Affairs >>	Finance Contribute your business acumen and financial and analytical expertise to provide the stewardship necessary to lead DSI to accomplishing our financial goals and objectives. Search for jobs in Finance >>
Business Development Research, identify and lead the creation of new business relationships in the industry to expand Daiichi Sankyo's portfolio to contribute to the company's continued success. Search for jobs in Business Development >>	Supply Chain & Distribution Our employees in supply chain and distribution optimize the supply of products, information and services through integrating key business processes, leveraging technology and responding to customer requirements while balancing cost, service and quality across the customer/supplier continuum. We offer benefits that reflect our respect for you, your work, and your family life. Our compensation programs are competitive and reward top performance and dedication. Search for jobs in Supply Chain & Distribution >>	Human Resources Drive the business strategy by contributing your expertise to ensure DSI attracts, develops and retains the best talent in the industry. Help ensure we create and maintain a work environment that reflects on our values. Search for jobs in Human Resources >>