PMPN_Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News, July/August 2015

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Page 17 of 83 • Pharmaceutical & Medical Packaging News July/August 2015 18 Salary Survey being afected by "moving manufac- turing to Mexico." And one manager reports: "Tran- sition of offshoring has resulted in reduction/elimination of temporary employees." One employee reports "lots of con- tract and foreign employees added," and says that "management knows there are no jobs, so they ask crazy hours." REGULATIONS Regulatory compliance does appear to prompt investment and hiring. When asked what is likely to influence compensation, one employee points to "regulations and inspection. Any regu- latory requirement/hurdle does reso- nate on the leadership's ears and they staf and compensate accordingly." W h e n a s k e d w h a t r e g u l a t i o n s and/or industry standards are present- ing new challenges, several respon- d e n t s p o i n t t o w a r d s e r i a l i z a t i o n requirements around the world, FDA's Unique Device Identification, updates to U.S. Pharmacopeia chapters, EU Good Distribution Practices, and inter- preting shipping test requirements. Several respondents also criticize the medical device excise tax provisions of the Affordable Care Act. "Medi- cal Device excise tax is taking needed money for development of new prod- ucts and product improvements," says one professional. Another professional says that he or she has "seen the loss of countless life- sciences jobs due to the medical device tax." "Medical device tax continues to require us to do more with less and has prevented us from acquiring additional staf," adds another. Another is hopeful: "Medical device tax repeal is likely to have a significant impact by putting raises back to their former percentages." One professional points to other market challenges, namely "medical insurance reimbursements. FDA clear- ance was hard enough, but reimburse- ments is more difficult and extends [our] timeline to get a start-up in mak- ing money and therefore survive!" QUALITY Packaging professionals report some eforts toward quality improvements, which could also prompt investment in departments. "We have only refocused our priori- ties on quality improvements, but not directly impacted by the economy," says one. Another reports "quality improve- m e n t s t o a v o i d / e l i m i n a t e f i e l d actions." OPPORTUNITIES Despite increasing regulations, increased offshoring, and the new lean approach, packaging profession- als in the pharmaceutical and medical device industries are pleased with their industries, their companies, and their positions. Perhaps it's because of respondent statements like this one: the "pharma- ceutical industry has relatively higher wages than average job in the market." But opportunity is for the qualified. This same respondent says: "we can aford to be a little more selective with skill sets." And survey respondents express the need for qualified personnel. One says the biggest challenge in developing a new package is "finding employees with [the] skill set to do it." Losing qualified employees seems to be an issue, too. For instance, when working with existing packaging equip- ment, respondents report challenges "ensuring repeatability as a result of employee turnover." Challenges such as serialization are bound to create ongoing opportuni- ties for skilled and experienced profes- sionals. For instance, one respondent reports a "lack of in-house technical expertise," so companies such as this one will certainly need to address it in some manner. And there's always work to be done: "Biggest challenges are always from interpretations of existing standards, primarily ISO 11607, and primarily issues from European regulatory bod- ies," says one professional. Another points toward "FDA, the constant expansion and evolution of requirements. We are never sure what they want, but you can be sure it is always more." METhODOLOGY Data and verbatim responses were obtained during an online survey of professionals in pharmaceutical and medical packaging. Between June 22, 2015, and July 13, 2015, e-mails were delivered to a total of 13,035 indi- viduals inviting them to complete a Web-based survey. The survey was closed with 178 total responses, a 1.4% response rate. The results presented in this article are based on the 90 respondents who indicated that they work full time at organizations best described as one of the following: a manufacturer of medical devices, pharmaceuticals, biologicals, in vitro diagnostics, or nutritional supplements. Respon- dents who appeared to work outside these organizations were manually removed from the results before final tabulation. Respondents were allowed to skip certain questions; in this article, we have provided the number of respon- dents answering certain questions. 0 Opportunity is for the qualifed. One respondent says that "we can afford to be a little more selective with skill sets."

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