Assistant Technical Writer

At Roche, we advance science so that we all have more time with the people we love.

Your Opportunity

To author and produce regulatory documents for submission to regulatory authorities. Includes authoring complex CMC sections of BLA, pre-meeting packages, and other regulatory documents. Working with guidance, the Assistant Technical Writer takes accountability for timely delivery of clear and concise regulatory documents, working effectively and closely with content owners, and applying regulatory standards such as the use of Model Documents and Storyboards. The Assistant Technical Writer applies scientific writing, document, and project management expertise and contributes to the functional excellence of regulatory documentation through process management, and identification of systems or tools to streamline content transfer from the originating functions into final submissions.

Responsibilities:

• Manages the preparation of a suite of regulatory documents with senior team members.

• Works with content owners and project teams to ensure that key information is clearly described.

• Creates and tracks timelines for the production of assigned documents in alignment with regulatory schedules.

• Actively contributes to best practices and continuous improvement. Represents the group in functional and cross-functional initiatives/projects when required.

• Identifies opportunities for systems or tools to be used for compliant transfer of figures, tables and other content into regulatory documents.

• Be a change agent to "make life easier" and "show what's possible". Help challenge conventional assumptions to develop and implement new technologies/processes/projects which enhance PTD's and Roche's performance.

• Provide exceptional customer service, technical support, and business services to customers and partners within PTDU and PTR.

Qualifications

• You have a Bachelor's degree or equivalent with 0-2 years of relevant work experience in editing or writing.

• Previous technical writing experience preferred.

Experience, Knowledge, Skills

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

• Experience in regulatory affairs and/or biotech CMC development functions preferred

• Experience of authoring and/or editing regulatory documentation preferred

• Project management skills: consistently achieves multiple tasks 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 atmosphere of openness and trust

• Self-starter. Must possess excellent business acumen, solid judgement, and able to work autonomously from established goals and strategic direction

• Able to handle multiple priorities, conflicts, and ambiguity

Relocation benefits are not available for this job posting.

The expected salary range for this position based in South San Francisco is $72,600-$134,800 for the Assistant Technical Writer level. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.
Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.