Senior Publisher

Senior Publisher
Gdańsk
What we do:


At Cognizant, we are dedicated to helping the worlds leading companies build stronger businesses - helping them go from doing digital to being digital.
In Poland, our offices are based in Gdańsk, Wrocław, and Kraków. With the capacity to support various clients, we offer a world of opportunities for both, professionals and graduates. You can expect five-star training, a chance to realize your career goals, and a range of benefits.
Apply and Be Cognizant!

 

What Client will you be supporting?


While employed by Cognizant, you will be supporting one of the worlds largest pharmaceutical companies, operating with 146 affiliates worldwide.  The Companys key areas of interest are: respiratory diseases, metabolic diseases, immunology, oncology and diseases of the central nervous system. The Client works in human pharmaceuticals, animal health, and biopharmaceuticals.  The Company is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

As a Senior Publisher you will compile regulatory documentation with 100% quality targets met as well as perform technical quality control of dossier documents prepared by other team members & guide and train Juniors.

 

Essential Skills and Qualifications:
  • Science, computer science or engineering degree,
  • More than 1 year of experience in pharmaceutical / Medical Device / any related industry, with relevant experience in electronic submission publishing, dossier management and dispatch of regulatory dossiers (US, EU, Asia, Latin America, etc),
  • Expert in submission publishing requirements globally,
  • Strong knowledge of Regulatory processes,
  • Excellent verbal and written communication skills,
  • Demonstrated ability to be innovative and a creative thinker,
  • High level of organizational awareness,
  • Experience with electronic document management systems, publishing tools, knowledge of documents publishing/document management,
  • Experience in eCTD publishing (this is a must).
Operational Responsibilities
  • Responsible for global regulatory submission / dossier publishing day-to-day activities and deliverables,
  • Compilation and maintenance of regulatory documentation as per the procedure in client repository,
  • Performing high level of files’ formatting using the client provided software (creating bookmarks, hyperlinks, file optimization etc.),
  • •Performing technical quality control of dossier documents ensuring adherence to internal and external document standards.,
  • Interacting with relevant stakeholders during preparation and quality control of reports and regulatory documentation,
  • Providing input and advice to project on relevant aspects of the submission process,
  • Supporting the client in aligning the process maps/SOPs/WI as per recent updates,
  • Providing support to other regulatory related activities as per the business requirements,
  • Associates to ensure Training & compliance to applicable CTS and BI "Quality Management System”. Following and establishing processes and procedures in the team and adhering to Client work instructions and procedures,
  • Compliance with KPI’s,
  • Customer satisfaction index.
What we offer:
  • Working from home scheme,
  • Great working atmosphere,
  • Possibility of morning and evening shifts,
  • Opportunity to be part of a fast-growing, well-known global company,
  • Role that allows you to grow both, professionally and personally,
  • Diverse and international work environment,
  • Excellent location and office space,
  • Competitive salary and benefits such as private healthcare, multisport card and more.
Prosimy o dopisanie klauzuli: Wyrażam zgodę na przetwarzanie moich danych osobowych zawartych w mojej ofercie pracy dla potrzeb niezbędnych do realizacji procesu rekrutacji (zgodnie z Ustawą z dnia 29.08.1997 r. o Ochronie Danych Osobowych; tekst jednolity Dz. U. z 2016 r. poz. 922 z późn. zm. ). Jednocześnie oświadczam, że zostałem/am poinformowany/a o dobrowolności podania danych osobowych oraz prawie dostępu do treści swoich danych i ich poprawiania.
APLIKUJ TERAZ

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COGNIZANT TECHNOLOGY SOLUTIONS POLAND SP Z O O

Lokalizacja: pomorskie/Gdańsk

Who is Cognizant? At Cognizant, we are dedicated to helping the worlds leading companies build stronger businesses - helping them go from doing digital to being digital. In Poland, our offices are...

2023-01-30