Imiphi Imisebenzi e-Greatest Demand?
Ngokomthetho we-Regulatory Affairs Professional Society (RAPS) ochwepheshe bezindaba ezilawulwayo bafuna, futhi ukukhula kuyadingeka. Ukwengeza, isinxephezelo semisebenzi eminingi enkundleni yemicimbi yokulawula iyakhula futhi.
"Ochwepheshe bezokulawula ... badlala izindima eziningi ezibucayi ekuletheleni imishanguzo yezokwelapha emakethe, kanti lo mkhakha ubhekene nokuphikisana nomkhakha wokuncipha," kusho umbiko wabo wamuva ku-website ye-RAPS.
Izindaba zokulawula zibhekene nokuhlola imikhiqizo yezokwelapha kanye nezidakamizwa ukuqinisekisa ukusebenza kwazo nokuphepha kwabo kuziguli nabathengi. Ukuhlolwa kwemitholampilo nokucwaninga kulawulwa yizinhlobo ezihlukahlukene zososayensi, odokotela , odokotela, ochwepheshe bezokwelapha zezokwelapha , nabasebenzi abaningi bezempilo abasebenza ngokubambisana nabachwepheshe bezindaba ezilawulayo, abanesibopho sokuqinisekisa ukuthi yonke imikhiqizo kanye nemithi ehambisana nemithi ihambisana nemithetho kahulumeni amadivayisi wezokwelapha nezidakamizwa.
Ukuze ufunde kabanzi mayelana nalesi sigaba esivame ukungazinaki embonini yezempilo, uMqondisi Omkhulu we-Regulatory Affairs Professional Society (RAPS) wabelane nathi ngolwazi olubanzi lolo msebenzi.
U-Sherry Keramidas, i-Ph.D., i-FASAE, i-CAE iphendule le mibuzo elandelayo ngokuphathelene nomsebenzi ezindabeni zokulawula:
Q. Yimiphi imisebenzi yezinqubo zokulawula ezifunwa kakhulu manje? Yimaphi amakhono neziqu ezidingekayo kakhulu emkhakheni we-RA?
A.
Kunesidingo sabaqeqeshi abalawula cishe cishe wonke umsebenzi wezinga lomsebenzi, ikakhulukazi kusuka ezingeni lobuchwepheshe kuze kube yi-VPs. Ukufunwa kubonakala kuzo zonke izindawo ezihlukene zokuqashwa - imboni (izinkampani ezincane nezincane phakathi kwezinkampani), ama-ejensi kahulumeni (njenge-US FDA, i-European Medicines Agency, njll), emitholampilo nasekuguleni https: // www. / yini-is-esibhedlela-isimo-1738754 izilungiselelo ital , amanyuvesi ezihilelekile ocwaningweni kanye nezivivinyo zomtholampilo, consultancies kanye nezinhlangano zocwaningo emtholampilo egijima ukuhlolwa clinic.
Abaqashi badinga ikakhulukazi abaqeqeshiwe abanezizinda ezihlobene nentuthuko, ukuphathwa kwempilo kanye / noma isimiso semikhiqizo yezempilo.
Ezikhundleni ezingeni lokungena, abaqashi bavame ukufuna abasebenzi abaqonda umkhakha wemikhiqizo yezempilo futhi banolwazi olumayelana nemithetho. Kumele benze okungaphezu kwekhanda imithetho. Ochwepheshe bokulawula kudingeka badinga imithetho efanele, kodwa futhi kufanele balandele izinguquko zokulawula futhi bahumushe umthelela wezimiso zomsebenzi ezinhlanganweni zabo. Kudingeka bakwazi ukusebenzisa ulwazi lwabo bese bacabanga ngokugxila. Kumele futhi kube abaxhumanisi abaphumelelayo, ukusiza ozakwabo kwezinye izindawo zezinhlangano zabo ukuthi baqonde ukuthi kunjani.
Njengoba bephakamisa izinga lezemisebenzi, kubaluleke kakhulu kubachwepheshe abaphethe ukuthuthukisa amakhono abo ebhizinisi (imali, ukumaketha, inqubomgomo, njll) futhi bakwazi ukuhlanganisa ulwazi lwabo lokulawulwa kweqhinga lebhizinisi kanye nokwenza izinqumo, kaningi emazweni angamazwe isikali.
Q. Yisiphi iseluleko ongayinikeza abantu abanesithakazelo emisebenzini ezindabeni zokulawula? Kufanele baqale kuphi, futhi kufanele bazenze kanjani ukuthi bathengise kakhulu abaqashi?
A.
Iningi labantu abenza ushintsho emisebenzini yokulawula banokuhlangenwe nakho okudingekayo okusebenzayo ezindaweni ezihlobene (isib. Ucwaningo nentuthuko, ikhwalithi noma umsebenzi wezokwelapha). Abanye bangasebenza enhlanganweni enomnyango wokulawula. Ezimweni ezinjalo, kuyasiza ukuxhuma nokukhuluma nabalingani bokulawula futhi ngisho nokufuna amathuba okuba "sithunzi" noma ukuqeqeshwa. Abaqashi bavame ukufuna abalingani abangakwazi "ukushayela phansi," futhi bathathe umsebenzi wangempela, obunzima uma sebeqashiwe. Ukuthola umsebenzi wokulawula ovela enhlanganweni kunganikeza ithuba lokuthola isipiliyoni esithile sokulawula ngaphambi kokwenza ushintsho olusemthethweni ensimini.
Esinye isici esibalulekile ekuthengiseni abaqashi abangaba yizimo zezokuLawulwa kweMigomo - ukuqinisekiswa kwe-RAC. I-RAC yiyona kuphela eqinisekisiwe, efundiswa ngemuva kokufunda, eprofetjhinali kumsebenzi wezokuphatha osebenza emdlalweni wemikhiqizo yezempilo.
I-RAC isekelwe ekuhlolisweni, ngokuhlolwa okwenziwe ngokusekelwe emsebenzini wangempela wezifundiswa zokulawula. Ucwaningo lwama-RAPS lubonisa ukuthi ochwepheshe abanegunya lokuqinisekisa i-RAC bathola okungaphezu kweontanga (okungaba ngu-10% ngaphezulu eNyakatho Melika), futhi bayaqhubeka emisebenzini yabo. Abanye abaqashi banikela okuthandayo kubanikazi be-RAC ekuqashweni kwabo, njengoba kubonisa izinga lokuqonda imithethonqubo, ikhono lokusebenzisa ulwazi olulawulwayo nokuzibophezela ekufundeni okuqhubekayo nokuthuthukiswa kolwazi (i-RAC idinga ukulungiswa njalo eminyakeni emithathu).
Kubalulekile ukuthi uqaphele ukuthi ukuhlolwa kwe-RAC kuhloselwe ochwepheshe abaneminyaka engama-3 kuya kwemihlanu yokubhekana nokulawula, ngakho-ke ukuthi umuntu angene ekulawuleni, kungase kube into yokufaka izinhlelo zabo zokuthuthukiswa komsebenzi iminyaka embalwa phansi komgwaqo .
Q. Yiziphi izinhlelo zemfundo ongasikhuthaza kubantu abanentshisekelo kumsebenzi emibandela yokulawula?
A. Kunezinamba eziningi ongakhetha kuzo kulabo abanesithakazelo sokuthola ukulawulwa ukubasiza ekwakheni ulwazi lwabo ngokulawulwa kwemikhiqizo yokunakekelwa kwezempilo. I-RAPS inikeza izifundo eziningi ze-intanethi ezihlanganisa imibono ebalulekile yokulawulwa kwemikhiqizo yezempilo kanye nezindaba zokulawula esigabeni ngasinye sempilo yomkhiqizo nasezindaweni ezahlukene zomhlaba. I-RAPS inikezela isitifiketi ezindabeni zokulawula zamadivayisi wezokwelapha kanye / noma imithi, ezuzwa ngokuqedela uchungechunge lwalezi zifundo, kanti i-RAPS inikeza nezincwadi eziningi zokufunda kanye namanye amathuluzi okufunda njengezinkomfa, ama-webcasts, njll. Amanyuvesi amaningi unikele isitifiketi izifundo noma degrees master ekulawuleni.
Q. Kubayini omunye umuntu angaba nesithakazelo emsebenzini wokuphatha izinto? Yiziphi izinto ezinhle kakhulu mayelana nokusebenza kumkhakha we-RA?
Ukulawula kuyinkinga enzima futhi enamandla. Imisebenzi kanye nemithwalo yemfanelo ihlanganisa ulwazi namakhono ezivela ezindaweni eziningi-isayensi nobuchwepheshe, amasimu omtholampilo, umthetho, inqubomgomo, ibhizinisi. Kubantu abaningi, lokhu kunikeza amathuba okwandisa nokusebenzisa ulwazi lwabo namakhono ezindaweni ezintsha.
Izici ezishintshayo zomsebenzi wokulawula ziyabonakala nakanjani ukuthi lo msebenzi usuquke kanjani nezinguquko zesayensi yezokwelapha nobuchwepheshe obugqugquzela ukuthuthukiswa komkhiqizo, ukuthuthukiswa komhlaba wonke wemikhiqizo yezokunakekelwa kwempilo kanye nezidingo ezishintshayo zomphakathi. Futhi-ke, ekugcineni, umsebenzi wokulawula ubalulekile ekwenzeni imikhiqizo yezempilo ephephile futhi esebenzayo kubantu emhlabeni jikelele. Umsebenzi ungakwazi ukuziqhenya ngempela.
Q. Yiziphi ezinye zezinselelo ezinkulu kakhulu mayelana nabasebenzi ezindabeni zokulawula? Yini eyinkimbinkimbi kunabo abafuna umsebenzi kanye namanje ochwepheshe be-RA?
Phakathi kwezinselele ezinkulu kunazo zonke ukuhluka nobubanzi bomsebenzi. Ukuze ugcine wamanje futhi ukhule, ochwepheshe abalawulayo kudingeka badlale ezindaweni eziningana ezihlukene kunendawo eyodwa encane. Lokhu futhi kuyisici esihle kubachwepheshe abaningi. Kukhona ukuthi kunezindawo eziningi ezimpunga emithethweni, efuna ukuhlaziywa ngokucophelela, ukucabangela isimo, nokuchazwa. Ngenkathi ozakwabo kanye nabaphathi bangase bafune impendulo elula ecacile, lokhu akunjalo njalo; okushiwo yimithethonqubo ekhona noma engase ibe khona ingase ibe yinkinga enkulu.
Ukulawula futhi kuyindawo yokubiza embonini nakwezinye izinhlangano, inethonya elingaphansi kwezinye izindawo ezifaka ukukhangisa nokuthengisa. Kodwa-ke, ngokuqhubekayo, ama-CEO aqaphela ukubaluleka okubaluleke kakhulu kobuchwepheshe bokulawula njengengxenye ebalulekile yeqhinga jikelele lebhizinisi. Okokugcina, ekuthuthukiseni isu elilawulayo, ochwepheshe bokuphatha kumele bacabangele ukulinganisa okubanzi komhlaba jikelele, kubandakanya izinketho zomhlaba wonke zokukhiqiza umkhiqizo, ukuthunyelwa komhlaba jikelele, nokuthengiswa, kanye nokukhangisa okuhlukahlukene, okungafani nokukhangisa okulandelwayo emva kwezindawo eziningi.
Kubantu abafuna umsebenzi abaqeqeshiwe kakade kwezinye izindawo, bangase babhekane nenselele ukuthola ithuba lokuthuthela esimweni sokulawula ngaphandle kokuhlangenwe nakho okulawulayo. Kwezinye izimo, kungase kudingeke bamukele isinyathelo phansi esihlokweni nasenxephezelo baze bakwazi ukukhombisa amakhono abo. I-Ph.D. Umqondisi wezobuchwepheshe akakwazi ukuhamba ngokuqondile endaweni yomqondisi olawulayo.
Q. Ubona kuphi inkundla ye-RA eminyakeni emihlanu, futhi iminyaka eyishumi, kusukela manje? Ingabe kuzoba khona ushintsho oluphawulekayo ekudingeni noma ucabanga ukuthi izindlela zokusebenza zamanje zizoqhubeka ngokukhula nokufunwa?
Kunzima ukubikezela ngokucacile ukuthi lo msebenzi uzobukeka kanjani eminyakeni emihlanu noma eyishumi, kodwa kuye kwafakazela ukuthi kufanele uvumelane nezibalo ezinyangeni ezimbalwa ezedlule, ngakho-ke kunengqondo ukukholelwa ukuthi kuzoqhubeka nokuvumelanisa nokuguquka. Ukucwaninga ukuthi i-RAPS iqhube iminyaka engaphezu kwengu-20 ibonisa ngokucacile ukuthi ububanzi bomsebenzi wabasebenzi abalawulayo buye bavumelana nezinguquko zesayensi, ibhizinisi kanye nomthethosisekelo. Iqembu elithile lelwazi eliyisisekelo sochwepheshe nokuzimisela kwabachwepheshe abalawulayo ukuqhubeka nokwandisa ulwazi lwabo ezindaweni eziningi ezingahle kube yisibonakaliso esihle sokuthi lo msebenzi uzoqhubeka uvumelanisa futhi ukhule.
Isidingo kanye nesidingo semikhiqizo yokunakekelwa kwezempilo ephephile futhi ephumelelayo kulindeleke ukuba ikhule eminyakeni engamashumi eminyaka ezayo, iqhutshwa abantu abaguga futhi ikhule isikhathi eside, ukwanda kwezifo ezingapheli, nokuqwashisa okubanzi nokutholakala kwemikhiqizo yezempilo kubantu emhlabeni wonke. Isidingo kanye nesidingo sabaqeqeshi abalawulayo ezindaweni lapho umsebenzi uqhubeka khona (Asia, Latin America, Middle East neAfrika) kulindeleke ukuba ukhule kakhulu eminyakeni emihlanu ezayo nangaphezulu. Isidingo eNyakatho Melika naseYurophu kufanele sihlale sinamandla.
Silindele ukuthi ochwepheshe abaphethe babe nomthelela omkhulu nakakhulu-kokubili ezinhlanganweni zabo futhi ngokubanzi emzamweni wokuthuthukisa izinhlelo zokunakekelwa kwezempilo kanye nezinhlelo zokunakekelwa kwezempilo. Lo msebenzi usuvele wenza izinzuzo ezibalulekile ezinqumweni zebhizinisi nezenqubomgomo, kodwa uhlobo lomsebenzi (umzimba wawo wolwazi, ububanzi bomsebenzi kanye nemfundo nokuqhubeka nokuthuthukiswa kobuchwepheshe kwamalungu ayo) kufanele ukubeka lo msebenzi ukuba ube nethonya elikhulu nakakhulu ikusasa.
Q. Yikuphi okunye okuzizwa ukuthi kubalulekile kulabo abaqeqeshiwe bamanje kanye / noma abazayo be-RA ukuthi bazi ngalesi sikhathi? Unayo yini enye iseluleko, izitayela, njll, ungathanda ukwabelana nabantu abangase baphenye imisebenzi emkhakheni we-RA?
A. Lena umsebenzi othakazelisayo noyinselelo obuye ube "umsebenzi wokucabanga". Ukuze uphumelele ubuchwepheshe bokulawula kumele kube ngumcabango ohlakaniphile ozimisele futhi okwazi ukusiza ozakwabo-abacwaningi nabanjiniyela, abakhwalithi nabasebenzi bokukhiqiza, ochwepheshe bezokwelapha, ukuthengisa, kanye nokuthengisa, abasebenzi bezezimali kanye nabaphathi-baqonde ukulawulwa komthetho kuwo wonke umuntu isigaba sempilo yomkhiqizo. Esikhathini esidlule, kwezinye izinhlangano, ochwepheshe bezolawulo babhekwa njenge "imigwaqo" ekuqalisweni komkhiqizo nasekukhangiseni. Lokho kushintshile. Bethonya kakhulu ekwenzeni izinqumo manje kunanini ngaphambili, futhi abaphathi beze baqaphela ukubaluleka kobuchwepheshe bokulawula ekusizeni ukugwema amaphupho angenzeka. Ubuchwepheshe bokulawula buyisimo esiyingqayizivele njengomgcini wokuthembela komphakathi (ukuqinisekisa ukuthi imithetho kahulumeni ilandelwa) futhi njengomgcini wesithombe nobuqotho benhlangano ayisebenzelayo.