To prepare regulatory documents for submission to regulatoryauthorities within subject area (clinical/safety). Working with minimalguidance, the Senior Regulatory Documentation Scientist takes accountabilityfor delivering regulatory documents, working effectively and closely with key contentowners in the relevant functions. The Senior Regulatory Documentation Scientistapplies scientific writing, document and project management expertise andcontributes to the functional excellence of regulatory documentation throughprocess management.
Major Responsibilities and Accountabilities:
Manages the preparation of a suite of regulatory documentse.g. Clinical Dossier, suite of Safety Documents
Leads Writing/Editing Team for preparation of ClinicalDossiers/Safety Reports
Reviews documents to ensure compliance with documentationquality standards, regulatory requirements and consistency of messages acrossall documents for a product/ within a clinical dossier
Prepares specifications for outsourced work (writing/reviewof documents) and serves as Roche liaison for project purposes
Plans and creates timelines for the production of assigneddocuments e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planningand resourcing of all documents assigned to Writing/Editing Team including work tobe outsourced
Actively contributes to best practices and continuousimprovement within RegulatoryDocumentation. Represents the group in functionaland cross functional initiatives/projectswhen required
Acts as a mentor to new members/less experienced membersof the Documentation group
In addition, assumes the responsibilities of a RegulatoryDocumentation Scientist
Who You Are
Bachelor’s degree or equivalent.
Advanced degree in life sciences or other relevant fieldpreferred.
Experience, Knowledge, Skills
Demonstrated clear, high-quality scientific writing stylein the English language
Experience in regulatory affairs or related functions indrug development, knowledge of international regulations, and previousexperience of authoring and/or editing regulatory documentation.
Aptitude or proven ability to guide the work of others
Ability to independently analyze and synthesize data froma broad range of disciplines
Project management skills: consistently achieves multipletasks and goals on-time
Strong interpersonal and verbal communication skills
Influencing skills: can influence without authority.
Ability to work effectively in a team environment,establishes strong collaborative relationships, resolves conflict by creating an atmosphereof openness and trust
Thinks through problems clearly and logically
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.