Kodi ndi Ntchito ziti zomwe Zakufunika Kwambiri?
Malingana ndi a Regulatory Affairs Professional Society (RAPS) akatswiri a zamakhalidwe abwino akufunika, ndipo chiwerengero chikuwonjezeka. Kuonjezerapo, malipiro a ntchito zambiri m'mayendedwe olamulira akukula.
"Othandizira Olamulira ... amasewera maudindo ofunika kwambiri pobweretsa zatsopano zamalonda ku msika, ndipo ntchitoyi yatsimikiziridwa kuti ikutsutsana ndi makampani ogonjetsa," lipoti lawo laposachedwapa likunena pa webusaiti ya RAPS.
Nkhani zoyendetsa ntchito ndizoyesa kuyesa mankhwala ndi mankhwala kuti atsimikizire kuti ali ndi mphamvu komanso chitetezo kwa odwala ndi ogula. Mavuto ndi zofukufuku zimayang'aniridwa ndi asayansi osiyanasiyana, madokotala , ogwira ntchito zachipatala, akatswiri a zachipatala , ndi othandizira ambiri ogwira ntchito zaumoyo omwe amagwira ntchito mogwirizana ndi akatswiri a zaumoyo, omwe ali ndi udindo woonetsetsa kuti mankhwala onse ndi mankhwala akugwirizana ndi malamulo a federal zipangizo zamankhwala ndi mankhwala.
Kuti mudziwe zambiri za izi nthawi zambiri sankanyalanyaza ntchito ya zamalonda, Mtsogoleri Wamkulu wa Regulatory Affairs Professional Society (RAPS) adagawana nawo nzeru zake zambiri za ntchitoyi.
Sherry Keramidas, Ph.D., FASAE, CAE adayankha mafunso otsatirawa okhudzana ndi ntchito zowonetsera:
Q. Ndi ntchito ziti zoyendetsera ntchito zomwe zikufunika kwambiri pakali pano? Ndi luso liti ndi ziyeneretso zomwe zimafunikira kwambiri m'munda wa RA?
A.
Pali chosowa cha akatswiri olamulira pafupifupi ntchito iliyonse, makamaka kuchokera kwa akatswiri mpaka ku VPs. Chofunika chikuwoneka pazinthu zosiyanasiyana zolemba ntchito - mafakitale (makampani ang'onoang'ono ndi akuluakulu mpaka maiko ambiri), mabungwe a boma (monga US FDA, European Medicines Agency, etc.), kuchipatala ndi kuchipatala https: // www. 1738754 makonzedwe a ital , maunivesiti omwe akuphatikizidwa mu kafukufuku ndi mayesero a zamankhwala, ma consultancies ndi mabungwe ofufuza zachipatala omwe amayendetsa mayesero a zachipatala.
Olemba ntchito amafunikira kwambiri akatswiri ndi zochitika zokhudzana ndi chitukuko, kayendetsedwe ka moyo wa moyo ndi / kapena kayendedwe ka mankhwala ogulitsa mankhwala.
Pa maudindo apamwamba, olemba ntchito nthawi zambiri amafunsira ogwira ntchito omwe amamvetsetsa za mankhwala ogulitsa mankhwala ndikudziŵa zambiri za malamulo. Ayenera kuchita zambiri osati kungoweza pamtima malamulo. Othandizira oyenerera amafunika kudziwa malamulo oyenera, komabe, ayenera kuyang'anitsitsa kusintha kosinthika ndikusanthula zomwe zimaperekedwa kuntchito ya mabungwe awo. Ayenera kukhala okhoza kugwiritsa ntchito chidziwitso chawo ndikuganiza molakwika. Ayeneranso kukhala othandizira othandizira, kuthandiza othandizana nawo m'madera ena a mabungwe awo kumvetsa tanthauzo.
Pamene akukwera ntchito, zimakhala zofunikira kwambiri kwa akatswiri otsogolera kukonzanso maluso awo a zamalonda (ndalama, malonda, ndondomeko, etc.) ndipo amatha kuphatikiza nzeru zawo zogwirizana ndi kayendetsedwe ka ntchito zamaganizo ndi kupanga zisankho, nthawi zambiri pamayiko osiyanasiyana kukula.
Q. Ndi malangizo ati omwe mungapereke kwa anthu omwe ali ndi chidwi chogwira ntchito mu Malamulo Oyendetsa Ntchito? Kodi ayenera kuyamba kuti, ndipo ayenera kukhala otani kwa ogwira ntchito?
A.
Anthu ambiri omwe amasintha ntchito yawo yothandizira ali ndi zofunikira zogwira ntchito m'madera ena (mwachitsanzo, kufufuza ndi chitukuko, khalidwe kapena ntchito zamakono). Ena angagwire ntchito mu bungwe lomwe lili ndi dipatimenti yoyang'anira. Zikatero, ndizothandiza kulumikizana ndi kulankhula ndi anzanu ogwira ntchito komanso kuyesetsa kupeza "mthunzi" kapena kuphunzitsidwa. Olemba ntchito nthawi zambiri amayang'ana ofuna ofuna "kugunda pansi," ndikugwira ntchito yeniyeni yowonongeka atangotumizidwa. Kupeza ntchito yowonongeka kuchokera mu bungwe kungapereke mpata wopezera zochitika zowonjezera musanapange kusintha kwa boma kumunda.
Chinthu china chofunika kwambiri kuti tigulitsidwe kwa olemba ntchito ndi Regulatory Affairs Certification - chidziwitso cha RAC. RAC ndiyo yokhayo yodalirika, yotsatila maphunziro, yodziwika kuti ndi yodziwikiratu kwa akatswiri olamulira omwe akugwira ntchito muzitsamba zamagetsi.
Bungwe la RAC ndilopenda kafukufuku, ndi kafukufuku wopangidwa mothandizidwa ndi ntchito ya akatswiri olamulira. Kafukufuku wa RAPS 'amasonyeza kuti akatswiri omwe ali ndi chivomerezo cha RAC amapeza zambiri kuposa anzawo (pafupifupi 10% ku North America), ndipo akupitiriza ntchito zawo. Olemba ena amapereka mwayi kwa ogwira ntchito ku RAC mu ntchito yawo yobwerekera, chifukwa amasonyeza kumvetsetsa kwa malamulo, luso logwiritsa ntchito chidziwitso chodziletsa komanso kudzipereka kuti apitirize kuphunzira ndi kupititsa patsogolo chidziwitso (RAC imafuna kukonzanso zaka zitatu).
Ndikofunika kuzindikira kuti, kafukufuku wa RAC amapangidwa kwa akatswiri omwe ali ndi zaka zitatu kapena zisanu za zochitika zoyenerera, kotero kuti munthu akungoyamba kumene, kungakhale chinthu chokhazikitsa ntchito yawo yopanga ntchito kwa zaka zingapo pansi pa msewu .
Q. Ndi mapulogalamu ati a maphunziro amene mungapangire anthu omwe akukhudzidwa ndi ntchito pazinthu zoyendetsa?
A. Pali zofunikira zambiri kwa iwo omwe akufuna kukhala otsogolera kuti awathandize kumanga chidziwitso chawo pankhani ya mankhwala. RAPS imapereka maphunziro ambiri pa intaneti omwe amaphatikizapo mfundo zofunika zokhudzana ndi mankhwala okhudzidwa ndi malamulo ndi zowonongeka pa gawo lirilonse la moyo wa mankhwala ndi magawo osiyanasiyana a dziko. RAPS imaperekanso chikalata pa nkhani zoyendetsera zipangizo zachipatala ndi / kapena mankhwala, zomwe zimapindula mwa kumaliza maphunziro osiyanasiyana, ndipo RAPS imaperekanso mabuku osiyanasiyana komanso zofunikirako monga misonkhano, ma webusaiti, etc. Amayunivesite angapo perekani maphunziro a masitifiketi kapena madigiri a master muyendetsedwe.
Q. Chifukwa chiyani munthu angakhale ndi chidwi ndi ntchito pazolowera? Kodi ndi zinthu ziti zabwino zokhudzana ndi ntchito ku RA?
Kulamulira ndi gawo lovuta komanso lamphamvu. Udindo ndi maudindo zimaphatikizapo chidziwitso ndi luso lochokera m'madera osiyanasiyana-sayansi ndi zamakono, zipatala, malamulo, ndondomeko, bizinesi. Kwa anthu ambiri, izi zimapereka mwayi wowonjezera ndikugwiritsa ntchito chidziwitso ndi luso lawo kumadera atsopano.
Makhalidwe apamwamba a ntchito yowongolera akuwonetsanso momwe ntchitoyi yasinthira ndi kusintha kwa sayansi ya zachipatala ndi teknoloji yomwe ikutsogolera chitukuko cha chitukuko, kuwonjezeka kwa mgwirizano wa chigawo cha mankhwala okhudzana ndi thanzi komanso kusintha kwa zosowa za anthu. Ndipo ndithudi, pomalizira, ntchito yowonongeka ikuphatikizapo kubweretsa mankhwala abwino ndi ogwira ntchito kwa anthu padziko lonse lapansi. Ndi ntchito yomwe mungakhale nayo yonyada.
Q. Ndi zifukwa ziti zomwe zimakhala zovuta kwambiri pazokambirana pazochitika zoyendetsa? Kodi ndi chovuta chotani kwa ofunafuna ntchito komanso akatswiri a RA masiku ano?
Zina mwa zovuta kwambiri ndizosiyana ndi kukula kwa ntchitoyi. Kuti apitirizebe kukula ndikukula, akatswiri otsogolera ayenera kuganizira malo osiyanasiyana osati malo amodzi. Izi ndizinso zabwino kwa akatswiri ambiri. Kumeneko kumakhala kovuta kwambiri pamapangidwe, kufuna kufufuza mosamala, mkhalidwe woganiza, ndi kutanthauzira. Ngakhale ogwira ntchito ndi ogwira ntchito angakhale akuyang'ana yankho lolunjika bwino, izi sizingatheke; Zotsatira za malamulo omwe alipo kapena omwe angakhalepo angakhale ovuta kwambiri.
Kuyendetsa ndi malo opindulitsa mu mafakitale komanso m'mabungwe ena, ali ndi mphamvu zochepa kusiyana ndi malonda ena ndi malonda. Komabe, owonjezereka, a CEO akuzindikira kufunika kopindulitsa kwamakhalidwe oyendetsera monga chigawo chofunikira cha malonda onse. Pomalizira, pokonza njira zowonongeka, akatswiri otsogolera ayenera kuganizira zovuta zonse padziko lonse lapansi, kuphatikizapo makina amitundu yambiri yopangira katundu, kutumiza kwapadziko lonse, ndi malonda, ndi malonda osiyanasiyana, malonda osiyana siyana komanso zofunikiranso zochitika pamadera osiyanasiyana.
Kwa ofunafuna ntchito omwe ali kale ntchito zogwira ntchito m'madera ena, angakumane ndi vuto kupeza mwayi wokhala m'malo olamulidwa popanda zochitika zowonongeka. Nthawi zina, iwo amafunika kulandira gawo limodzi pamutu ndi malipiro mpaka athe kusonyeza luso lawo. Ph.D. Mtsogoleri wamkulu wa ma laboratory sangathe kusunthira mwachindunji ku malo oyang'anira udindo.
Q. Kodi mukuwona kuti munda wa RA muzaka zisanu, ndi zaka khumi, kuyambira pano? Kodi padzakhalanso kusintha kwakukulu kwafuna kapena mukuganiza kuti ntchito zamakono zikupitilira pa kukula ndi kufunika?
Zili zovuta kufotokozera bwino zomwe ntchitoyi idzayang'ana zaka zisanu kapena khumi, koma zatsimikizirika kuti zidzasinthika pazaka zingapo zapitazi, kotero ndizomveka kukhulupirira kuti zidzasinthira ndikusintha. Kafukufuku amene RAPS wachita kwa zaka zoposa 20 akuwonetsa kuti kuchuluka kwa ntchito za akatswiri otsogolera zakhudzana ndi kusintha kwa sayansi, bizinesi ndi malamulo. Zolingaliro zosiyanasiyana zomwe ndizo maziko a ntchito ndi kufunitsitsa kwa akatswiri otsogolera kuti apitirize kuwonjezera chidziwitso chawo mmadera osiyanasiyana zingakhale zisonyezero zabwino kuti ntchitoyi idzapitiriza kusintha ndi kukula.
Chosowa ndi kufunika kwa mankhwala ogwiritsidwa ntchito mosamala ndi oyenera akuyenera kukula m'zaka makumi anayi, kutsogoleredwa ndi anthu okalamba, kuwonjezeka kwa matenda akuluakulu, komanso kuzindikira kwakukulu ndi kupeza mwayi wogulitsa mankhwala pakati pa anthu padziko lonse lapansi. Chosowa ndi kufunika kwa akatswiri olamulira m'madera omwe ntchitoyi idakalipo (Asia, Latin America, Middle East ndi Africa) ikuyembekezeka kukula kwambiri m'zaka zisanu zotsatira. Chofunika ku North America ndi ku Ulaya chiyenera kukhala cholimba.
Tikuyembekeza akatswiri otsogolera kuti akhale okhudzidwa kwambiri-m'mabungwe awo komanso molimbika kwambiri kuti athetse patsogolo chithandizo chamankhwala komanso machitidwe a zaumoyo. Ntchitoyi ikupanga kale zopindulitsa pazinthu za bizinesi ndi ndondomeko, koma chikhalidwe cha ntchito (chidziwitso chake, kuchuluka kwa ntchito ndi maphunziro ndi chitukuko chokhazikika cha akatswiri ake) chiyenera kuika ntchitoyi kukhala yowonjezera tsogolo.
Q. Ndi chiyani chinanso chimene mukuganiza kuti ndi chofunikira kwa akatswiri omwe alipo pakadali pano komanso / kapena adzadzidzidzi kuti adziwe nthawiyi? Kodi muli ndi malangizo ena, machitidwe, ndi zina zotero, mukufuna kugawana ndi anthu omwe angakhale akufufuza ntchito m'munda wa RA?
A. Ichi ndi ntchito yosangalatsa komanso yovuta yomwe ndi ntchito yoganiza. Kuti apambane, akatswiri otsogolera ayenera kukhala oganiza bwino omwe ali okonzeka komanso othandiza othandizira anzawo, kuchokera kwa ochita kafukufuku ndi injini, kuti akhale opambana ndi ogwira ntchito, ogwira ntchito zachipatala, malonda, malonda, ndalama ndi ogwira ntchito - amvetsetse zomwe zimachitika pa aliyense siteji ya moyo wa mankhwala. M'mbuyomu, m'mabungwe ena, akatswiri otsogolera ankawoneka kuti ndi "njira zowonongeka" popanga katundu ndi kulengeza. Izi zasintha. Iwo ali ndi mphamvu kwambiri pakupanga zisankho tsopano kuposa kale lonse, ndipo otsogolera adziwa kufunika kwa luso lokhazikitsa malamulo pofuna kuthandiza kupeŵa mavuto. Katswiri wodziletsa ali ndi udindo wapadera monga woyang'anira chikhulupiliro cha boma (kuonetsetsa kuti malamulo a boma akutsatiridwa) komanso monga wosamalira fano ndi umphumphu wa bungwe lomwe akugwiritsira ntchito.