Country Approval Specialist

Pharmaceutical Product Development (PPD)

AU-Melbourne-Melbourne AU Queens Road


E ss e ntia l Fun c ti on s :

• Pre pa re s, rev iew s a n d c o or dinate s, u n de r guidan c e , lo c a l re gulat ory s u bm issi on s (MoH, E C, a ddit ion a l spe c ia l n a tio n a l l oc a l a pplica tion s if a ppli c a ble , e.g. ge n e t h e ra py ap pr o v a ls, v ira l sa f e ty dossie rs, imp ort l ic e n se) i n a lignme n t w ith globa l s u bm ission stra te gy .

• Prov ide s, un de r g u ida nc e lo c a l re gulat ory stra te gy ad v i c e (MoH &/ or E C) t o i n te rn a l c lie n ts.

• Prov ide s pro j e c t spe c if i c loca l SIA servic e s a n d c oordin a tion of t h e se proje c ts.

• Ma y h a v e c on ta c t w it h in v e stiga tors f or s u bm issi on re l a te d a c tiv itie s.

• Ke y -c o n ta c t a t co un tr y le v e l f or e ith e r E th i c a l or Re gul a tory su bm is sion -re la te d a c tiv itie s.

• Coordina te s, un de r g u ida n c e , with in te rnal f u nc tio n a l de pa rt me n ts to e n su re v a rio u s site sta rt -u p a c tiv itie s a re a ligned w ith s u bm issio n s a c ti v itie s a n d m u tu a lly a gree d up on time li ne s; e n s u re s a lignme n t of su bm is sion p r oc e ss f or site s a n d stu d y a re a ligned t o the criti c a l pa th f or site a c tiv a tion .

• Ach ie v e s PP D ’ s ta rge t cy c le t ime s f or sit e .

• Ma y w ork w ith t h e sta rt -u p CR A( s) t o pre pa re t h e re gulat ory co mplia nc e re v ie w pa ck a ge s, a s a pplica ble .

• Ma y de v e lop c ou n try spe c if i c Pa tie n t In f orma tion Sh ee t / Inf orme d C on se n t f orm d o cu me n ts .

• Ma y a ssist w ith gra n t b u dg e ts(s) a n d pa y me n t s ch e dul e s n e got ia tion s w it h site s.

• Su pports t h e co ordina tio n o f f ea sibilit y a c tiv itie s, a s re quired , in a c c orda nc e w ith a gree d time lin e s.

• E n te rs a n d ma in ta in s tria l s ta tu s in f orma tion re la tin g t o S IA a c tiv itie s on to PP D t r a ck in g da ta ba ses in a n a cc u ra te a n d t ime ly man n e r.

• E n su re s th e l oc a l c ou n try st u dy f ile s a n d f iling pr oc e sse s a re pre pa re d, set u p a n d ma in ta in e d a s

pe r P PD WP D s or a pplica bl e cl ie n t SOP s.

• Ma in ta in s k n ow le dge o f an d un de rsta n d P P D SOP s , Cli e n t SOP s/dire c ti v e s, an d c u rre n t re gulat ory guidelines a s a ppli c a ble t o servic e s pr ov ide d.

E ss e ntia l Fun c ti on s :

• Pre pa re s, rev iew s a n d c o or dinate s, u n de r guidan c e , lo c a l re gulat ory s u bm issi on s (MoH, E C, a ddit ion a l spe c ia l n a tio n a l l oc a l a pplica tion s if a ppli c a ble , e.g. ge n e t h e ra py ap pr o v a ls, v ira l sa f e ty dossie rs, imp ort l ic e n se) i n a lignme n t w ith globa l s u bm ission stra te gy .

• Prov ide s, un de r g u ida nc e lo c a l re gulat ory stra te gy ad v i c e (MoH &/ or E C) t o i n te rn a l c lie n ts.

• Prov ide s pro j e c t spe c if i c loca l SIA servic e s a n d c oordin a tion of t h e se proje c ts.

• Ma y h a v e c on ta c t w it h in v e stiga tors f or s u bm issi on re l a te d a c tiv itie s.

• Ke y -c o n ta c t a t co un tr y le v e l f or e ith e r E th i c a l or Re gul a tory su bm is sion -re la te d a c tiv itie s.

• Coordina te s, un de r g u ida n c e , with in te rnal f u nc tio n a l de pa rt me n ts to e n su re v a rio u s site sta rt -u p a c tiv itie s a re a ligned w ith s u bm issio n s a c ti v itie s a n d m u tu a lly a gree d up on time li ne s; e n s u re s a lignme n t of su bm is sion p r oc e ss f or site s a n d stu d y a re a ligned t o the criti c a l pa th f or site a c tiv a tion .

• Ach ie v e s PP D ’ s ta rge t cy c le t ime s f or sit e .

• Ma y w ork w ith t h e sta rt -u p CR A( s) t o pre pa re t h e re gulat ory co mplia nc e re v ie w pa ck a ge s, a s a pplica ble .

• Ma y de v e lop c ou n try spe c if i c Pa tie n t In f orma tion Sh ee t / Inf orme d C on se n t f orm d o cu me n ts .

• Ma y a ssist w ith gra n t b u dg e ts(s) a n d pa y me n t s ch e dul e s n e got ia tion s w it h site s.

• Su pports t h e co ordina tio n o f f ea sibilit y a c tiv itie s, a s re quired , in a c c orda nc e w ith a gree d time lin e s.

• E n te rs a n d ma in ta in s tria l s ta tu s in f orma tion re la tin g t o S IA a c tiv itie s on to PP D t r a ck in g da ta ba ses in a n a cc u ra te a n d t ime ly man n e r.

• E n su re s th e l oc a l c ou n try st u dy f ile s a n d f iling pr oc e sse s a re pre pa re d, set u p a n d ma in ta in e d a s

pe r P PD WP D s or a pplica bl e cl ie n t SOP s.

• Ma in ta in s k n ow le dge o f an d un de rsta n d P P D SOP s , Cli e n t SOP s/dire c ti v e s, an d c u rre n t re gulat ory guidelines a s a ppli c a ble t o servic e s pr ov ide d.

Kno w le dge , Sk il ls and Abil it ie s :

• E ff e c ti v e ora l a n d w rit te n c omm un i c a tion s k ills

• E xc e lle n t in te rpe rso n a l sk ill s

• Strong a tte n tio n t o de ta il a n d qua lity of d ocu me n ta tio n

• G ood n e got ia tion s k ills

• G ood c omp u te r s k ills a n d t h e a bilit y t o lea rn appr opria te sof twa re

• G ood En glish la n guag e a n d gra mma r skills

• Ba sic me dical/th e ra pe u tic a re a a n d me dical te rm in olog y k n ow le dge

• Ab ilit y t o w ork i n a tea m en v ironme n t or indep e n de n tl y , un de r dir e c tion , a s re quir e d

• Ba sic orga n iza tio n a l a n d pl a nn in g sk ills

• Ba sic k n ow le dge of a ll a ppli c a ble re giona l / n a tio n a l c o un try reg u la tory g u ide lin e s a n d E C

re gulat ion s

Kno w le dge , Sk il ls and Abil it ie s :

• E ff e c ti v e ora l a n d w rit te n c omm un i c a tion s k ills

• E xc e lle n t in te rpe rso n a l sk ill s

• Strong a tte n tio n t o de ta il a n d qua lity of d ocu me n ta tio n

• G ood n e got ia tion s k ills

• G ood c omp u te r s k ills a n d t h e a bilit y t o lea rn appr opria te sof twa re

• G ood En glish la n guag e a n d gra mma r skills

• Ba sic me dical/th e ra pe u tic a re a a n d me dical te rm in olog y k n ow le dge

• Ab ilit y t o w ork i n a tea m en v ironme n t or indep e n de n tl y , un de r dir e c tion , a s re quir e d

• Ba sic orga n iza tio n a l a n d pl a nn in g sk ills

• Ba sic k n ow le dge of a ll a ppli c a ble re giona l / n a tio n a l c o un try reg u la tory g u ide lin e s a n d E C

re gulat ion s


2020-09-15 00:00:00


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