Senior Medical Writer

Position Summary
- Prepare high-quality regulatory documents including clinical study reports, clinical summaries/overviews, study protocols, Investigator’s brochures, and informed consent forms.
- Handle more complex writing assignments and serve as a subject matter expert within the department.
- Plan, manage, and prepare internal/external communications of key scientific/clinical data, including abstracts, poster/oral presentations, manuscripts, congress materials, and educational/training materials.

Essential Functions
- Serve as medical writing lead on complex assignments; work with cross-functional teams on document strategies.
- Act as subject matter expert for assigned therapeutic/product areas.
- Mentor less experienced medical writers as needed.
- Identify and propose solutions to resolve issues/questions during the writing process (resolve or escalate as appropriate).
- Write, edit, and finalize CSRs, clinical summaries/overviews, eCTD summaries, study protocols, IBs, ICFs, and other regulatory documents.
- Write, edit, and finalize clinical/non-clinical publications, congress materials, educational/training materials, and other external-facing documents.
- Write effectively for diverse audiences (scientists, physicians, payers, regulators, patients).
- Collaborate with Regulatory Operations, Biometrics, and Clinical Operations to gather source data and finalize regulatory documents.
- Lead project team and document review meetings.
- Provide direction/solutions to cross-functional teams on document content expectations.
- Perform QC of clinical and nonclinical documents.
- Ensure documents are suitable for eCTD submissions via proper formatting and hyperlinking per guidelines.
- Perform other duties as assigned.

Qualifications
- Bachelor’s degree in science-related field with 4+ years of relevant industry/academic medical writing experience (or related experience in quality, regulatory, publications, clinical research, or product support/R&D); OR Master’s degree with 2+ years.
- Experience in NDA submissions; ability to write CSRs, IBs, clinical study protocols, and other regulatory submission documents.
- Strong scientific background in oncology, immunotherapy, or related field.

Skills/Abilities
- Proficient knowledge of AMA writing guidelines.
- Excellent English verbal and written communication skills.
- Extensive knowledge of FDA, EMA, and ICH guidelines.
- Deep understanding of drug development process and biopharmaceutical industry experience.
- Familiarity with clinical research principles; ability to interpret/present complex clinical data.
- Strong time/project management, attention to detail; ability to manage multiple projects.
- Strong critical/logical thinking; analyze problems, identify alternatives, implement resolutions.
- Collaborative working style in a dynamic environment.
- Highly proficient with MS Project; MS Office (Word, Excel, PowerPoint, Outlook); Adobe Acrobat; EndNote; and eCTD authoring templates.

Benefits (as stated)
- Medical, dental, and vision plan options.
- Health and financial wellness programs; Employer Assistance Program (EAP).
- Company paid and voluntary Life/AD&D; Short-Term and Long-Term Disability.
- Healthcare and dependent care flexible spending accounts.
- 401(k) retirement plan with company match.
- 529 education savings program.
- Paid Time Off (PTO): 11 holidays (and Unlimited PTO for exempt employees; non-exempt PTO includes 10 vacation days, 56 hours health pay, 2 personal days, 1 cultural day).

Application instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).