Roche

Entry Level/Senior/Principal Regulatory Documentation Scientist

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
14 Jan 2021
Closes
31 Jan 2021
Ref
202101-100927
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
  Regulatory Documentation Scientist (Entry Level/Senior/Principal)

 

Who we are

We are an innovative, curious and diverse company with 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we're constantly learning and growing, and seeking people who share the same ambitious vision.

We support our staff in the development of their knowledge and skills. Further local and global career opportunities are offered to people who demonstrate talent and aptitude.

The Opportunity

We currently have an opportunity for a Documentation Scientist to join our talented Global Product Development Regulatory Documentation team here in Welwyn. We welcome applications from people with different levels of experience for either the Regulatory Documentation Scientist, Senior Regulatory Scientist or Principal Regulatory Documentation Scientist role.  Offers will be made to the successful applicants for the level based on their experience.

Position Purpose:

Regulatory Documentation Scientist

The main purpose of the Documentation Scientist role is to prepare regulatory documents for submission to regulatory authorities. The Regulatory Documentation Scientist takes accountability for writing and delivering regulatory documents, interpreting scientific data, working effectively and closely with key content owners in the relevant functions to establish key strategic messages for the documents. The Regulatory Documentation Scientist applies scientific writing, editing, document and project management expertise and contributes to the functional excellence of regulatory documentation through process management and strategic partnering.  

Senior/Principal Regulatory Documentation Scientist

The main purpose of the Senior/Principal Regulatory Documentation Scientist role is to lead the preparation of complex regulatory documents and filings for submission to regulatory authorities. The Senior/Principal Regulatory Documentation Scientist takes accountability for writing and delivering regulatory documents, interpreting scientific data, working effectively and closely with key content owners in the relevant functions to establish key strategic messages for the documents. The Senior/Principal Regulatory Documentation Scientist applies scientific writing, regulatory knowledge, document and project management expertise and contributes to the functional excellence of regulatory documentation through process management and strategic partnering.  We are looking for strong leadership skills and so you should be an agile, strategic thinker with exceptional communication skills at all levels and have the ability to work effectively.  You should be able to influence teams and functions in defining dossier development strategies. 

 

Major Responsibilities and Accountabilities:

Regulatory Documentation Scientist

•        Prepares (writes or substantively edits) regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality and consistency with other documents where appropriate

•        Liaises with document contributors to gather information (including Licensing partners where relevant)

•        Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures planning and requests resources for all documents assigned to the Writing/Editing Team, including work to be outsourced.

•        Resolves issues, errors, or inconsistencies in data with contributors as appropriate

•        Reviews documents for: organization/clarity/grammar/scientific standards/internal consistency (e.g., between text and data displays).

•        Manages the review process, including leading/coordinating adjudication of review comments and incorporating review comments

•        Ensures that documents are published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory

•        Obtains and applies knowledge of Roche and regulatory guidelines, procedures and best practices across relevant documents

•        Participates as a member of key functional/cross functional team(s), ensuring that teams adequately plan for document deliverables

•        Actively contributes to best practices and continuous improvement within Regulatory Documentation

•        Keeps informed on regulatory, scientific and medical issues important to drug development, assigned products, and disease/therapeutic areas

Senior/Principal Regulatory Documentation Scientist

Same as Regulatory Documentation Scientist plus the following:

•     Lead the preparation of complex regulatory documents and filings for submission to regulatory authorities.

•     Influence teams and functions in defining dossier development strategies.

•       Train and mentor more junior writers in the team

 

Professional and Technical Requirements

•     Bachelor's degree or equivalent in life sciences or other relevant fields

•     Strong/extensive regulatory writing experience for the Senior/Principal level

 

Experience, Knowledge and Skills

•        Demonstrated clear, high-quality scientific writing style in the English language

•        Good interpersonal and verbal communication skills

•        Ability to independently analyze and synthesize data from a broad range of disciplines

•        Ability to work effectively in a team environment and establish strong collaborative relationships

•        Project management skills: consistently achieves multiple tasks and goals on-time

•        Experience of writing clinical and/or safety documents (eg IB, CSR, Module 2 documents, DSUR, PBRER, RMPs, etc) preferred but not essential

•        Experience in regulatory affairs or related functions in drug development preferred but not essential

 

Occasional overseas travel may be required.

If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.  In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression. 

To be considered for this position, please apply using the link below. When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

Please note that during the assessment process, we shall look at your experience, skills and competencies in relation to our current team, and decide what level you are. 

 

 

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche!

 

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

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