Contracts Associates

Contracts Associates is looking for another experienced Life Sciences attorney consultant to add to our team.

Ideal candidate will be available 40 hours a week to work virtually with some on site work as needed. Responsibilities include managing and overseeing preparation, negotiation, and execution of day-to-day pharmaceutical corporate contracts including without limitation, US and ex-US clinical trial agreements, CRO agreements and statements of work, health care provider consulting agreements, vendor and service contracts, master agreements, laboratory services agreements, material transfer agreements, supply agreements, confidentiality or non-disclosure agreements, and related agreements. Ability to handle multiple tasks for multiple clients in a fast-paced, high volume environment is essential. Willingness to take initiative, be proactive, and good people skills are a must. Coordinate with client teams regarding contract needs and priorities. Prepare draft agreements in response to clients requests using pre-approved client templates. Manage negotiations on clients’ behalf with outside parties regarding contracts, and communicate with client attorneys and/or project managers regarding the same. Generally work to ensure clear and prompt communication with clients’ attorneys, employees, and outside vendors regarding contracts. Keep up-to-date on legal issues relating to the pharmaceutical industry and contracts for the same, and perform miscellaneous tasks and other duties as required for effective implementation, management, and upkeep of clients’ contracts and agreements. JD, 3-5 years, in-house background in pharmaceutical company required; familiarity with healthcare industry and regulatory environment preferred. Understanding of PhRMA code, FDA, OIG guidances, False Claims Act, Anti-kickback and other healthcare related statutes and regulations.

If interested, please email your resume and a cover letter to: cms@contractsassociates.com

The above is the title of an upcoming seminar sponsored by the Food and Drug law Institute and, in a nutshell, the speaker’s opinion is an unequivocal “there should be no effect at all”.

The promotional flyer I received has the following synopsis: “(the) FDA should resist the temptation to allow cultural fears to influence regulation of GE animals; oppose calls for mandatory labeling of GE animals based solely on their GE character; refuse demands to apply the precautionary principle to regulation of GE animals; and apply nuanced ethical analysis to animal welfare issues involving GE animals.”

Really?  The founding of the predecessor of the FDA was a direct response to a cultural shift in America (influenced in part by the publication of Upton Sinclair’s “The Jungle”); a call for government oversight of food safety and truth-in-advertising for the numerous tonics being pushed by snake oil salesmen. It stands to reason that, if the government is instituting labeling guidelines for organic food and the like, there should also be labeling for GE animal products as some Americans may wish to make informed choices en shopping for their families.

I can’t see why the FDLI is sponsoring this seminar and I cannot imagine what type of professional would take time out of their day to attend it.  Why not just let the U.S. Beef and Cattle Industry sponsor their own seminars for FDA policy makers and leave the FDLI out of it? With a 2010 retail equivalent value of $74 billion, they can afford it. The Industry could probably also absorb any costs that mandatory labeling would cause them to incur but I don’t imagine that issue will be raised in this objective, unbiased seminar.

We visit NYC several times a year for conferences and client visits and we take a lot of taxi rides while we are there.  Last August, during one such trip, a NYC cabdriver was stabbed by a passenger and the story of his family, struggling to cope with his injuries and the costs of caring for a newborn, really stuck a cord with me.

Our company made a small contribution to the fund set up for him. I found the thank you letter to be especially touching and thought I’d post it here: NYC Taxi Drivers Letter. As our clients share in the support of these contributions we make, they enable us to help out people like Mr. Sharif and his family. We thank them too.