Scientific Technical Writer

Pionyr Immunotherapeutics, Inc., a growing well-funded clinical stage immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking an experienced Scientific Technical Writer.  This pivotal role, based at our South San Fransico location will provide support for the preparation of nonclinical, regulatory submission-supporting documents covering the functional areas of pharmacology, pharmacokinetics, toxicology, and CMC (chemistry, manufacturing, and controls). 

Specific Responsibilities include (but not limited to):

  • Working closely with scientific Subject Matter Experts (SMEs), drives document management from start to finish (ie, generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing and managing various processes (document reviews, QC, QA, formatting, and document archiving).
  • Critically reviews, interprets and conceptually organizes results from complex submission-supporting studies, deriving clear, concise and scientifically accurate key messages/documents that support regulatory submission strategies.

  • Provides editorial or review support for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals

  • Collaborates with cross-functional team members (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Quality, CMC etc.) to ensure accurate and timely completion/delivery of high-quality, scientifically supported documents

  • Provides editorial support, ensuring quality of all scientific content, with a focus on clarity, grammar, accuracy, and consistency, while maintaining adherence to proper format, regulatory requirements, and company guidelines/styles/drafting processes.

  • Initiates and manages multiple rounds of document review and ensuing revisions, interacting positively and professionally with all levels of reviewers from SME to senior management, effectively resolving conflicts and building consensus, as necessary
  • Simultaneously manages multiple overlapping projects at different stages and on separate development programs and contributes to overall process improvement.

  • Participates in key cross functional meetings to align on general strategy for content and authoring of documents.

  • Creates high-quality documents that meet domestic and international regulatory submission standards.

  • Maintains document history and manage version control of documents.

Requirements 

  • BS, MS, or PhD, preferably in a scientific or medical field. Advanced degree preferred. 
  • At least 5 - 7 years' experience in scientific writing; biotechnology/pharmaceutical sector experience is required.
  • Demonstrated experience in the preparation of study reports and Regulatory documents including IND and NDA submissions as well as scientific manuscripts, abstracts, posters, and presentations
  • Proficiency with Microsoft Office, SharePoint, Adobe Acrobat and document templates and document management systems; experience preparing figures using programs such as Adobe Illustrator or GraphPad Prism is preferred
  • Proficiency with medical/scientific terminology and demonstrated ability to incorporate drug development data into regulatory submissions.
  • Ability to work independently and collaboratively with cross functional teams in a fast-paced, team environment
  • Analytical thinker with excellent problem-solving skills and the ability to balance changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
  • Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure
  • Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents
  • Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with reference-gathering search tools
  • Excellent communication and writing skills, and the ability to collect, analyze, and present complex information in well‑constructed and persuasive documents
  • Ability to proactively propose and implement creative solutions and ideas
  • Excellent oral and interpersonal skills

How to Apply

Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume to careers@pionyrtx.com.

Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.