R&D -Senior Clinical Document Translation Project Manager -Beijing

Job description

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

·  Copperate with strong, independent technology group and experience digital & innovative ways of working
·  Be viewed as a trusted partner, shared goals and quality work

What you can contribute?

·  The senior clinical document Translation Project Manager / TPM is part of the Clinical Documentation team. Reporting hierarchically to the Clinical Document Translation Team Lead / CDT TL, the senior TPM is an experienced project manager, who not only acts as the translation lead to manage the clinical documents translations (in-house or outsourced) activitiesworldwide for major or complex submission projects in Sanofi Pharma, but also assists the CDT TL in translation process improvement, translation vendor management, and translation team development.
·  The senior TPM is the single contact person of Sanofi internal and external stakeholders (including Sanofi clinical document translation requestors, Sanofi CSU team members and translation resources such as translation services providers) for managing or coordinating the translation activities of clinical documents whatever the language of the translation, for major or complex submission projects (such as several studies conducted with the same product at the same time, with accelerated submission timelines) in Sanofi Pharma.
·  He/she is responsible for leading and coordinating the translation activities for the major or complex submissions worldwide in order to deliver final translations for each participating country in due time, in compliance with Sanofi procedures and regulatory requirements. He/ she also ensures the highest quality of translations within the pre-defined budget.
·  He/she assists the CDL TL and collaborates with Translation Service Manager in continuous improvement of clinical document translation processes, associated quality documents and operational guidance, and tools.
·  He/she assists the CDL TL in translation vendor management, including monitoring vendor activities and metrics for continuous improvement on translation quality and productivity, with cost reduction; attending regular work group meetings with translation vendor for improvement and evolution of translation system/tools to meet Sanofi stakeholders’ needs.
·  He/she assists the CDL TL in recruitment of team members and team development. He/she is also responsible for training and coaching newcomers.
·  He/she continuously supports the business needs associated with the production of clinical documents translation in an evolving and competitive regulatory environment.
·  He/she contributes to translation projects, and promotes and supports the implementation of new technologies to increase efficiency, productivity, and savings.

MAJOR DUTIES & RESPONSIBILITIES (what the job does)

1.Management of Translation Activities for Major or Complex Submission Projects:

·  Manage translation activities for major or complex submission projects conducted by Sanofi worldwide by leading or coordinating the translation management activities by individual TPM of the CTS organization, and deliver high quality translation timely to meet the submission timelines in each participating country.
·  Coordinate the planning, collecting and following-up submission translation requirements in close collaboration with Sanofi requesters and translation services providers.
·  Ensure the coordination and monitoring of the submission projects progress with all concerned stakeholders (Sanofi clinical team members and internal/ external translators) from planning to closing, including scope, schedule, resource, cost, risk and remission.
·  Ensure active and timely communication with all stakeholders concerned so that high quality translations are delivered as per submission translation planning.
·  Ensure compliance with Sanofi Quality Documents for translation management process.
·  Provide constant support to Sanofi clinical team in regards to document translation purposes, questions and issues.
·  Ensure the collection, compilation and reporting of translation metrics for the submission project to the CTS Head.

2.Translation processes and quality documents:

·  Contribute to continuous improvement of clinical document translation processes, to meet the ever-evolving regulatory requirements.
·  Contribute to the writing and updates of CTS Quality Documents including SOPs, operating guidelines, as well as training modules.

3.Translation tools:

·  Contribute to the evolution of the Sanofi CTS tools used for managing translations including the translation request management tools, planning and activity tracking tools, as well as translation tools (Translation Memories, Term Bases): this includes the development of User Requirements, Testing of new tools, etc.

4.Translation vendor management:

·  Monitor translation vendor activities and metrics for continuous improvement on translation quality and productivity, with cost reduction.
·  Attend regular work group meetings with translation vendor for improvement and evolution of translation system/tools, to meet Sanofi stakeholders’ needs.

5.Training of newcomers:

·  Organize training and coaching to new comers, on the clinical documents translation process and system/tools.

6.Support to customers:

·  Provide process and technical support to the Sanofi stakeholders (internal and external) involved in clinical document translation activities so that quality translations are delivered as per study planning, approved budget, regulatory requirements and Sanofi clinical development strategy.
·  Participate to training sessions dedicated to the entire community of Sanofi users when evolutions of the clinical documents translation process or tools are implemented.

7.Translation strategy:

·  Contribute to the CTS efforts to ensure consistent processes, preparation and presentation of clinical document translations to maintain quality and expedited preparation of translations, while also ensuring adherence to company standards.

V – QUALITATIVE DATA

A. Major Challenges/Problems.  List challenges or problems commonly encountered in this job, how they are solved, and with whom they would typically be solved.

·  Establish communication network within and outside of Clinical Documentation, particularly with CSO Trial Operations representatives, CSU and Medical Affairs team members, as well as external stakeholders (such as translation services providers to deliver timely high quality translations. This responsibility requires strong capacities to adapt translation strategies to answer unanticipated issues that frequently occur at the study level in order to not jeopardize Clinical Trial Application/ CTA submissions to Health Agencies and Ethics Committees worldwide.
·  Need to anticipate any issues (e.g. document format not supported by the Computerized Assisted Translation tools, languages requiring specific pre-formatting before translation, etc.) for more than 60 languages that the CTS has to manage, in order to avoid issues that would jeopardize the delivery of the translation as per CTA submission planned date.
·  Need to be aware of sophisticated ITS translation tools developed by vendors, as well as the next to come technological evolutions of these tools, so that Sanofi is in capacity to anticipate the evolution of its existing clinical document translation tools, and propose adapted development. The TSM position requires a in-depth interest for the IT translation domain and its evolution.

B. Decision Making Authority.  Identify the types of decisions made by this job as well as those that must be referred to a superior (i.e., authority to implement plans, personnel decisions, changes to policy, etc.)

·  Organization of translation workload.
·  Selection on a project basis of ad hoc translation external service providers, when relevant.
·  Update of Sanofi translation tools (Translation Memories and Term Bases).
·  Follow-up of translation budget.
·  Refer to hierarchy: 
·  Changes in timelines for document translation releases including prioritization if necessary.
·  Project organizational changes needs; major shifts in resources; crisis management; important department, interface, or client communications.
·  Expected processes and tools evolutions for managing translation activities, and associated services provided to customers.

C. Key Internal and External Relationships.  Describe the most significant contacts outside the regular work unit.  Include frequency and purpose.

·  Sanofi Pharma Trials Operations, CSUs, Regulatory Affairs, Controlling, Procurement
·  Translation Service providers worldwide

What you should have?

·  Minimum bachelor degree in Clinical Medicine, Pharmaceutics or other related major
·  Project Management experience (minimum 5 years) in a complex, highly regulated and multicultural environment.
·  Knowledge and experience (minimum 3 years) in the translation domain including the management of translation services companies, and the tools and technologies used for the translation of documents.
·  Experience in the pharmaceutical industry.
·  Knowledge of clinical development area is essential.
·  Experience in budget planning and follow-up.
·  Fluency in English.
·  Strong computer software skills (eg, MS Office, Windows) and knowledge of Computerized Assisted Translation/ CAT tools (eg, Translation Memories, Translation Management Systems, Machine Translation, Glossaries) used for managing translation request workflows and for leveraging the knowledge capacity of translation tools.

 If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

·  Capacity to analyze situations and needs, and subsequently develop and implement appropriate action plans.

Must be open to new ideas and approaches, and

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.