Safety Label Change Project Coordinator

3 days ago


Ljubljana, Ljubljana, Slovenia Lek, a Sandoz company Full time €40,000 - €60,000 per year

Job Description
As a Safety Label Change Coordinator, you will play a pivotal role in ensuring the timely and seamless execution of fast-track and exceptional safety label changes (SLCs) across all departments. This position demands a high level of coordination, precision, and strategic oversight to manage critical issues, monitor performance, and drive alignment across functions. You will be instrumental in supporting the Strategic SLC Coordinator Committee, facilitating cross-functional collaboration, and ensuring compliance with internal standards, legislation, and best practices. This is a dynamic opportunity to contribute to patient safety and regulatory excellence while working in a fast-paced, impact-driven environment

Key Responsibilities
Key responsibilities include, but are not limited to:

  • Overseeing Safety Label Changes (SLCs) categorized as "fast-track" and "exceptional" end-to-end across all involved functions and ensure timely implementation.
  • Coordinating remediation action in case of delayed submissions / implementation.
  • Evaluating and reporting about financial impact of SLC related issues.
  • Identifying critical issues and escalate to Strategic SLC Coordinator team.
  • Recommending systematic and continuous improvement actions across the organization.
  • Monitoring performance and KPIs for SLCs.
  • Acting as a competent and strong business partner to ensure alignment and effective coordination of activities for the SLC-end-to-end process across all functions involved.
  • Supporting Strategic SLC Coordinator team, e.g. by assessing metrics, regular reporting on end-to-end operational activities, proactively identify areas of improvement and bring them for discussion.

What You Will Bring To The Role

  • University degree in Life Science or other relevant field. An advanced degree (e.g., Master's or MBA) in project management or pharmaceutical sciences is considered an advantage.
  • Minimum 3-5 years experience in project management or 3 years experience in supply chain, manufacturing or quality assurance.
  • Proactive and solution-oriented approach to problem solving
  • Fluent in English (written and spoken).
  • Knowledge of Microsoft Office.

Possible job locations:
Slovenia (Ljubljana), Poland (Strykow)
We offer a
permanent contract with 6 months probation period
. You are kindly invited to submit your application in English language, including CV, by

.

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

The future is ours to shape

Commitment To Diversity & Inclusion
Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

________________________________________________

Kot Koordinator projektov za spremembe informacij o varnosti zdravil boste imeli ključno vlogo pri zagotavljanju pravočasne in nemotene izvedbe pospešenih in izjemnih sprememb varnostnih informacij v vseh oddelkih. Položaj zahteva visoko raven usklajevanja, natančnosti in strateškega nadzora za obvladovanje ključnih tveganj, spremljanje uspešnosti ter zagotavljanje usklajenosti med funkcijami. Aktivno boste podpirali delo strateške SLC-koordinatorske ekipe, spodbujali medfunkcijsko sodelovanje ter zagotavljali skladnost z zakonodajo, internimi pravili, dobrimi praksami in poslovnimi cilji. Gre za dinamično priložnost, kjer boste prispevali k varnosti pacientov in odličnosti na področju regulative v hitro spreminjajočem se okolju.

Klju
č
ne odgovornosti
Ključne Odgovornosti Vključujejo, Vendar Niso Omejene Na

  • Nadzor nad celotnim procesom spreminjanja informacij o varnosti zdravil (SLC), ki so razvrščene kot "hitre" ali "izjemne" varnostne spremembe. Zagotavljanje pravočasne izvedbe v sodelovanju z vsemi vključenimi funkcijami.
  • Koordinacija sanacijskih ukrepov v primeru zamud pri oddaji ali implementaciji sprememb.
  • Ocenjevanje in poročanje o finančnih vplivih težav, povezanih s spremembami.
  • Prepoznavanje ključnih tveganj in eskalacija ustreznim deležnikom.
  • Predlogi sistemskih in trajnostnih izboljšav procesov na ravni celotne organizacije.
  • Spremljanje uspešnosti in ključnih kazalnikov uspešnosti za področje SLC.
  • Delovanje kot kompetenten in zanesljiv poslovni partner, ki zagotavlja usklajenost in učinkovito koordinacijo aktivnosti v celotnem procesu SLC med vsemi vključenimi funkcijami.
  • Podpora strateški SLC- koordinatorski ekipi, na primer z analizo kazalnikov, rednim poročanjem o operativnih aktivnostih ter proaktivnim prepoznavanjem področij za izboljšave in vključevanjem v razprave.

Vaš Doprinos k Delovnem Mestu

  • Visokošolska izobrazba naravoslovne ali druge ustrezne smeri. Višja izobrazba (npr. magisterij ali MBA) s področij vodenja projektov ali farmacije predstavlja prednost.
  • Minimalno 3-5 let izkušenj s področja vodenja projektov ali minimalno 3 leta izkušenj s področja oskrbovalnih verig, proizvodnje ali zagotavljanja kakovosti.
  • Proaktiven in rešitveno usmerjen pristop k reševanju težav
  • Aktivno znanje angleškega jezika (ustno in pisno)
  • Poznavanje orodja Microsoft Office

Kaj Nudimo
Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj.

Možne lokacije dela:
Slovenija (Ljubljana), Poljska (Strykow).

Z izbranim kandidatom bomo sklenili
delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev
. Prijave z življenjepisom v angleškem jeziku lahko oddate najkasneje do

preko spletne povezave.

Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje ljudi več kot 100 narodnosti. Na ta dosežek smo ponosni, a si želimo še več

Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.

Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci ter sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero.

Prihodnost je v naših rokah

Predani Smo Raznolikosti In Vključenosti
Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.

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