Sanofi recruitment of clinical document translation project manager

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see10041 | reply0 | 2021-8-27 20:09:59 | 显示全部楼层 |Reading mode
Author: Translator


北京市

I - JOB SUMMARY

Briefly summarize the primary purpose or function of the job (why does it exist?):

The clinical document Translation Project Manager/TPM is part of the Clinical Documentation team. Reporting hierarchically to the clinical Document Translation Lead, and functionally to the Head of Clinical Documentation Translation Services, the TPM is in charge of managing Sanofi Pharma clinical documents translations (in-house or outsourced) worldwide.

The TPM is the 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 the translation of clinical documents whichever the language of the translation.

The TPM is responsible for delivering translations 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.

The CDTPM provides project management support and expertise to Sanofi clinical teams in the area of translation: this includes collecting requirements, analyzing needs, planning resources and budget, identifying and providing translation materials (such as Translation Memories, Term Bases, etc.) that will enable the translation, coordinating the translation tasks with stakeholders including the quality controls of the final draft of translations, and participating in the development of Sanofi translation tools capability in order to deliver high quality translation on time and within budget.

He/she participates to the continuous improvement of clinical document translation processes, associated quality documents and operational guidance, and tools.

The CDTPM 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.

II – KNOWLEDGE AND SKILL REQUIREMENTS

(Minimum requirements for assignment to this job)

Knowledge And Skills:

Project Management and Coordination:

Project Management experience (minimum 2 years) in a complex, highly regulated and multicultural environment.

Knowledge 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 desirable.

Experience in budget planning and follow-up.

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

Must be open to new ideas and approaches, and able to leverage existing/new networks and tools to nourish projects.

Capacity to create and encourage creative and innovative approaches and problem-solving when necessary and not compromise professional integrity.

Excellent organizational and time management skills for the coordination of multiple concurrent translation projects; ability to handle multiple tasks, and be detail-oriented.

Able to work under pressure when necessary, and in a deadline-driven environment; resourceful, confident and self-directed.

Demonstrated work ethics, integrity, and professional conduct.

Languages and Tools:

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.

Communication:

Good communication/interpersonalskills; ability to interact and communicate professionally with all levels of the organization and external partners.

Willingness to challenge “steady-state” and take risks in innovating alternative working practices.

Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment.

Listen to user feedbacks, open to recommendations for enhancements.

Inter-cultural sensitivity and understanding to help teams work together.

Ability to mentor, transmit knowledge and develop expertise on clinical documents translation processes.

Customer-focused; capable of working collaboratively across different cultures and time zones.

Formal Education And/Or Experience Required:

Diploma in Project Management or equivalent.

Experience with, and a good understanding of, drug development and clinical research.

Experience in translation management and project management is a strong advantage.

MAJOR DUTIES & RESPONSIBILITIES (what the job does)

1. Management of Translation Projects:

Manage translation projects for clinical studies conducted by Sanofi worldwide by implementing the mixed sourcing model defined at the level of the Clinical Documentation Translation Services organization, and deliver high-quality translation timely.

Plan, collect and follow-up clinical document translation requirements in close collaboration with Sanofi requesters and translation services providers.

Work with relevant functions to pre-analyze the document subject to translation, confirm translation model and identify expertise and tools needed for performing the translation.

Ensure the coordination and monitoring of the 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 study 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.

Work on billing after project closure.

Ensure Sanofi translation tools (Translation Memories, Term Bases, etc.) are consistently updated to leverage translation memory.

Is responsible for management, version control, and archiving of translation files.

Ensure the collection, compilation and reporting of translation metrics to the Clinical Documentation Translation Services Head.

2.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 the training of newcomers, as well as to training sessions dedicated to the entire community of Sanofi users when evolutions of the clinical documents translation process or tools are implemented.

3.Translation tools:

Contribute to the evolution of the Sanofi Clinical Documentation Translation Services 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 processes and quality documents:

Contribute to the writing and updates of Clinical Documentation Translation Services Quality Documents including SOPs, operating guidelines, as well as training modules.

5.Translation strategy:

Contribute to the Clinical Documentation Translation Services 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.

III – 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.

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.)

Decisions made by the job on a daily basis:

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.

On a daily basis, interactions with:

Sanofi Pharma Trials Operations, CSUs, Regulatory Affairs, Controlling, Procurement

Translation Service providers worldwide

在赛诺菲,多样性和包容性是我们如何运作和嵌入核心价值不雅观的根底。我们认识到,要真正发掘多样性所带来的丰富多彩,我们必需以包容为先导,并拥有一个工作场所,在那里,这些差别能够茁壮成长,并被操作起来,让我们的同事、患者和客户的生活更丰富多彩。我们尊重和颂扬我国人民的多样性、他们的布景和经历,并为所有人提供平等的时机。

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