Contact Us

Home > Career Home >

Latest News

Future Demand For Science Talent Grows In Garden State.

12/15/11

Pooled results of the STARS E-III and STARS J-V studies presented at ASH 2...

12/12/11

New Analysis of Data Presented at AHA Regarding Effect of Effient (Prasugr...

11/16/11

Stay Connected!

select

Hot Jobs

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.

Contact Us

U.S. Corporate Headquarters
Daiichi Sankyo, Inc.
Two Hilton Court
Parsippany, NJ 07054
Main Line: 973 944 2600

Directions

Global Development
Daiichi Sankyo Pharma Development
399 Thornall Street
Edison, NJ 08837
Main Line: 732 590 5000

Directions

Corporate Responsibility

At Daiichi Sankyo, everything we do leads back to our ultimate goal of improving lives. We are passionate about making a profound impact on those around us.

Benefits and Compensation

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.

Company Culture

The foundation of our culture is based on our core values of innovation, integrity and accountability.

About Us | Responsibility| Research & Development | Products | Careers