Senior Medical Writer

Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.

The Medical Writer is responsible for developing high-quality, scientifically-valid clinical, nonclinical, and regulatory documents for pipeline products according to international regulatory requirements and internal document standards. This role involves interactions on a regular basis with many internal departments including Clinical Sciences, Clinical Operations, Drug Safety and Pharmacovigilance, Translational Medicine, Biostatistics and Data Management, and Regulatory Affairs. This role also oversees work done by contract or consultant medical writers. This position reports to the Vice President of Regulatory Affairs and Quality Assurance.

Specific responsibilities include:

  • Writing and integration of appropriate statistical and clinical data into protocols, investigator brochures, clinical and nonclinical study reports, responses to regulatory questions, and other clinical and regulatory documents
  • Managing the overall development and approval process for assigned documents within timelines, including documentation generation, initiation of review process discussions on proposed revisions, and document completion in collaboration with other study team members
  • Critically analyzing complex information and collaborating with clinical and statistical teams on data description, presentation, and analysis
  • Providing support for production of scientific publications and presentations
  • Representing medical writing on project teams and actively participating in interactions including provision of scientific background information as needed
  • Developing and maintaining in-depth therapeutic and product operation knowledge
  • Establishing and maintaining technical style guides and document templates
  • Providing quality control review of various regulatory and medical communications documents
  • Coordinating work performed by consultant medical writers

Requirements:

Minimum Education/Experience

  • Bachelor’s degree (or equivalent) in life sciences, Graduate Degree preferred
  • 5+ years of experience in the pharmaceutical industry, or equivalent, in medical/regulatory/publication writing in pharmaceutical, biotech, or medical communications
  • Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English
  • Experience writing, editing, reviewing, and formatting clinical and/or nonclinical regulatory documents; prior NDA/BLA/MAA submission experience preferred
  • Detailed knowledge of ICH guidelines applicable to medical writing.
  • Understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, the regulatory environment including FDA/ICH guidelines, and principles of GXP/ICH/CTD and other global standards

Qualifications:

Other Qualifications

  • In-depth knowledge of MS Word and use of templates
  • A Self-motivated, self-disciplined self-starter who is able to function independently as well as part of a team
  • Ability to coordinate the efforts of team members to resolve comments, and produce a final high-quality document
  • Independently motivated with good problem-solving skills allowing analysis, synthesis, and compilation of data from a broad range of disciplines
  • Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
  • Experience with EDMS such as Veeva Vault advantageous