Principal Medical Publications Writer

Role Summary

The Principal Medical Publications Writer will lead the preparation, development, and support of high-quality publications, documents, and writing activities, including but not limited to scientific literature reviews, citation documentation/management, abstracts, posters, manuscripts (real-world and clinical), plain-language summaries, letters to the editor, review articles for submission to peer-reviewed journals, conferences, and other medical education and medical communication pieces (print and digital) that support our Medical Affairs strategy. This role will serve as a subject matter expert, providing strategic guidance and oversight across departments with minimal supervision, ensuring that all publications meet regulatory standards, Good Publication Practices (GPP), and company policies.

Responsibilities

• Serve as a subject matter expert; and as the medical writing lead on complex writing assignments within and across departmental team(s) on document strategies.
• Lead project team meetings and document review meetings, follow up on actions, and provide direction and solutions to cross-functional teams on expectations for document content.
• Adhere to established regulatory standards, as well as company Standard Operating Procedures (SOPs), client standards, and company approved templates when completing medical writing projects, on-time and on-budget.
• Write, edit, and finalize clinical and nonclinical publications, manuscripts, journal abstracts, congress materials, educational/training materials, and other external-facing documents.
• Serve as peer reviewer providing review comments to give maximum clarity of meaning, accuracy, relevance and to ensure that medical communications objectives are met. This includes reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Ensure that all publication activities are of high scientific and medical quality and meet Good Publication Practices standards, align with SOPs and are documented appropriately.
• Ensure adherence to ICMJE/GPP and company policies and procedures for publications, staying abreast of any new advances and guideline updates.
• Manage the development and execution of a ‚Äúrolling‚Äù strategic publication plan for clinical and real-world evidence (RWE) studies, ensuring alignment with the medical and clinical development strategy and adhering to industry best practices (e.g., GPP, ICMJE, PRISMA, CONSORT, etc.).
• Lead the development, review, editorial, approval, and submission of manuscripts, abstracts, posters, and presentations across clinical trials, real-world evidence studies, and health economics outcomes research (HEOR).
• Collaborate with internal and external authors, key opinion leaders (KOLs), and research partners to develop scientific publications.
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Support necessary literature reviews and publication listings to pharmacovigilance department for use in periodic safety update reports (PSURs), and benefit-risk evaluations (PBRERs) as required.
• Perform ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor‚Äôs degree in science-related fields with 10+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience.
• Master‚Äôs degree in science-related fields with 8+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience.
• Doctorate‚Äôs degree or equivalent in science-related fields with 6+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience.
• Strong expertise in clinical trial and RWE (Real World Evidence) publications, including phases I-IV, observational studies, registry data, and HEOR (Health Economics and Outcomes Research) required.
• Proven track record of leading publication strategies, delivering peer-reviewed publications, and congress presentations required.
• Experience in scientific writing, editing, and communicating complex data to diverse audiences.
• Experience writing scientific medical publications such as journal manuscripts, abstracts, and congress materials required.
• Strong scientific background in oncology, immunotherapy, or related field is required.
• CMPP (Certified Medical Publications Professional) or AMWA (American Medical Writers Association) Certification is preferred.

Knowledge, Skills, & Abilities

• Proficiency with publication and reference management systems (e.g., iEnvision, EndNote, Mendeley, Zotero, PubMed or similar).
• Deep understanding of clinical study design, biostatistics, and data interpretation.
• Strong knowledge of publication guidelines and compliance standards (GPP, ICMJE, Sunshine Act, Pharma Code of Conduct).
• Strong knowledge of AMA writing style requirements, along with publication guidelines and compliance standards (GPP, ICMJE, Sunshine Act, Pharma Code of Conduct).
• Excellent verbal and written communication skills in English.
• Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
• Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously.
• Ability to write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.
• Understands budget specifications for assigned projects and working within the budgeted hours.
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Ability to work collaboratively in a dynamic environment.
• Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote.

Working Environment / Physical Environment

• The position works either onsite in El Segundo, CA or in Torrey Pines, CA; or remotely depending on the candidate‚Äôs geographic location.
• Regular work schedule is Monday ‚Äì Friday, within standard business hours. Flexibility is available with manager approval.
• Travel approximately 10-15% of the time.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.