Intern - Product Development - Regulatory Business Operations - Disclosures and Data Sharing

South San Francisco
California, United States of America

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The Position

Length: 1 Year

Start Date: TBD

Responsibilities:

Intact & Cross-Functional Teams

  • Participates in site and/or regional PD Regulatory Disclosures departmental meetings
  • As needed, advises as an ad hoc member in Regulatory Affairs Functional Teams (RAFT) for assigned product development projects. Represents Regulatory Disclosures and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects



Regulatory Disclosures

  • Performs adhoc business analysis leveraging business analysis tools to enable team track and plan work efficiently
  • Demonstrates quick learning and capability to understand business data and processes spanning across Roche systems
  • Helps team with building tool capability, communication and resources for operational efficiencies
  • Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
  • Identifies studies required for registry and results postings, including applicable trials for results postings on relevant external websites
  • Works with cross-functional team members to obtain data, reviews and approvals required for completion of registry and results entries on internal and external websites
  • Monitors workflows for registry and results entries to ensure timely and on-target completion
  • Completes document and data uploads in applicable systems
  • Tracks correspondence with cross-functional teams and departments via departmental mailboxes and ensures appropriate responses are provided in a timely manner



Other

  • Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Disclosures-specific systems, processes or other relevant tools
  • Completes routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
  • Participates in other special projects, as and when assigned, or otherwise requested
  • Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
  • Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines

Qualifications:

  • Bachelors Degree preferred (life sciences disciplines strongly preferred)
  • Average of 3 or more years’ relevant experience in the pharmaceutical/biotechnology industry. Some previous experience in regulatory affairs or other product development functions is preferred
  • Business analysis tools experience eg Tablaeu, Spotfire etc
  • Medical writing and/or editing experience is preferred
  • Some understanding of international regulations, processes and issues in drug/biologics development is preferred. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
  • Some understanding of product and safety profiles
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Fluent English and other language skills as needed



Desired Abilities:

  • Has impeccable ethics.
  • Outstanding attention-to-detail
  • Has working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g. clinical development, clinical operations, biostatistics, commercial operations, etc.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Good interpersonal, verbal communication and influencing skills: can influence without authority
  • Strong written communication skills
  • Good business presentation skills: is comfortable and effective when presenting to others, internally or externally
  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
  • Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
  • Works well within teams and is effective in collaborating with others internally and externally
  • Ability to travel

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.


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