Cmc Editor (Submission Manager)

**The Position**:
**Duration - 18 Months**
Primary duties and responsibilities:
- Edit complex technical documents for clarity, grammar, spelling, and punctuation. Ensure adherence to applicable regulatory (e.G., CTD) and Roche guidelines
- A key member of local filing teams, provide ongoing expertise regarding regulatory submissions and guidance on compliance, timing and other relevant matters
- Facilitates communication and collaboration to meet submission timelines and plan future requirements.
- Manage the flow of documents via document-sharing systems (e.G., SharePoint) and document management-systems (e.G., Documentum) and ensure version control throughout the submission generation process (writing, review, and internal approval)
- Coordinate and provide training on documentation systems and tools and collect relevant submission related data
- Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders’ decisions
- Collaborate with internal partners (e.G., Regulatory Publishing, Project Management, Business Systems, etc.)
- Providing input on future system enhancements, business process updates, and submission model documents
Additional Responsibilities
- Facilitate knowledge sharing and best practice workshops contributing to continuous improvement
- Lead or is an active member of teams for special or ongoing initiatives and project
- Participates in and/or otherwise supports development and implementation of new or updated PTR and/or -specific systems, processes, or other relevant tools.
- Includes supporting user acceptance testing for new or updated systems or electronic tools
- Ability to travel and work internationally
Quality Related Job Accountabilities
- Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PT and PTR. Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.
- Contributes to development and maintenance of policies and/or Standard Operating Procedures and related document management processes.
- Ensure compliance with Roche standards, ICH, and other guidelines for incorporation into eCTD submissions
- Follows regulations and company policies, and complies with all Roche Standard Operating Procedures
- Demonstrates a continuous improvement mindset, with identifying and recommending opportunities to streamline or improve processes
Qualifications:
- Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or related field
- Proficiency in RIM - Regulatory Information Management system - preferred but not mandatory
- Strong track record as an editor, including at least three years of professional experience, in a scientific or technical field preferred but not mandatory
- Previous experience with regulatory documents (e.G., in CTD structure and other ICH, FDA, and EMA guidelines) and global submission dossiers or in the biotech or pharmaceutical industry is beneficial
- Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems (e.G., Documentum) and document sharing systems (e.G., SharePoint)
- Strong organizational and time management skills and ability to deliver under pressure and work flexibly to support changing assignments and priorities in an independent and reliable manner
Competencies &
Skills
- Strong written and verbal communication skills
- Listens well and expresses ideas fluently and eloquently, is open to the input of others, can be depended on to tell the truth regardless of the circumstances
- Understands the perspectives of different functional areas in the organization
- Gathers information and thinks through problems clearly and logically, and makes timely decisions
- Effectively manages change;
explaining the context,answering questions, and patiently listening to concerns
- Project management:
consistently achieves multiple tasks and goals on-time
- Proactively manages issues as, or before, they arise
- Recognizes and rewards hard work and dedication to excellence (e.G., contributions of peers).
- Fosters an exchange of ideas and support amongst colleagues
- Able to help others link and prioritize their work with the mission of PTR and Roche
- Articulates long-term objectives and strategies, and is good at promoting an idea or vision
**This position is not eligible for relocation support.**
NOTE:
All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process
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