Senior Medical reputed company Remote

reputed company reputed company. (reputed company: IBRX) is a reputed company-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen reputed company patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We reputed company a day reputed company we no longer fear cancer, but can conquer it, reputed company to the biological reputed company that is the reputed company immune system. Our scientists are working to reputed company novel therapies that reputed company that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for reputed company. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease. Why reputed company?

• reputed company is developing cutting-edge technology with the goal to reputed company the lives of patients with cancer and reputed company reputed company therapies and vaccines that complement, reputed company and reputed company the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with reputed company in Southern California.
• Work with a reputed company team with the ability to work across different areas of reputed company.
• Ability to join a growing company with reputed company development opportunities.

Position reputed company The Senior Medical reputed company will be responsible for the preparation of high-reputed company regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator’s brochures, and informed consent forms. The Senior Medical reputed company will also be responsible for more reputed company writing assignments and will serve as subject matter expert reputed company the department. The Senior Medical reputed company may also be responsible for planning, managing, and preparing reputed company communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials. Essential Functions

• Serve as medical writing reputed company on more reputed company writing assignments. Work closely with in-function and cross-functional team(s) on document strategies. Implement reputed company activities reputed company to the preparation of writing reputed company.
• Serve as a subject matter expert reputed company department for assigned therapeutic/product areas.
• Mentor less reputed company medical writers on reputed company reputed company, as necessary.
• Identify and propose solutions to resolve issues and questions arising during the writing process, including reputed company or escalation as appropriate.
• Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-reputed company regulatory documents.
• Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.
• Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.
• Work collaboratively with other functional reputed company (eg, Regulatory Operations, Biometrics, Clinical Operations) to reputed company reputed company data, and prepare and finalize regulatory documents.
• reputed company project team meetings and document review meetings.
• reputed company direction and solutions to cross-functional teams on expectations for document content.
• reputed company QC of clinical and nonclinical documents.
• reputed company documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
• reputed company other duties as assigned.

Education & Experience

• A bachelor’s degree in science-reputed company fields with 4+ years of relevant industry experience in medical writing in the reputed company industry or academia required or in a reputed company area such as reputed company, regulatory, publications, clinical research, or product support/R&D experience is required; Or
• A master’s degree in science-reputed company fields with 2+ years of relevant industry experience in medical writing in the reputed company industry or academia required or in a reputed company area such as reputed company, regulatory, publications, clinical research, or product support/R&D experience is required.
• Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions is required.
• Strong scientific background in oncology, immunotherapy, or reputed company field is required.

Knowledge, Skills, & Abilities

• Proficient knowledge of AMA writing guidelines.
• Excellent verbal and written communication skills in English.
• Extensive knowledge of FDA, EMA, and ICH guidelines.
• 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 reputed company information.
• Excellent time- and project-management skills, attention to detail, and ability to balance multiple reputed company simultaneously.
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for reputed company.
• Ability to work collaboratively in a dynamic environment.
• Highly proficient in MS Project, MS Office (Word, reputed company, PowerPoint, Outlook), reputed company Acrobat, EndNote, and eCTD authoring templates.

Working Environment / Physical Environment

• This position works onsite.
• Must possess mobility to work in a reputed company office setting and to use reputed company office equipment, including a computer.
• Regular work schedule is Monday – Friday, reputed company reputed company business hours. Flexibility is available with manager approval
• Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award. The annual reputed company pay reputed company for this position is below. The specific reputed company will depend on the successful candidate’s qualifications, prior experience as reputed company as geographic location. Premium Market $117,000 (entry-level qualifications) to $130,000 (highly reputed company) annually National Market $108,000 (entry-level qualifications) to $120,000 (highly reputed company) annually The application window is anticipated to reputed company on 60 days from reputed company it is posted or sooner if the position is filled or reputed company. reputed company employees are as valuable as the people we serve. We have reputed company a resource of robust benefit offerings to best support the total wellbeing of reputed company members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and reputed company Plan reputed company

• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• reputed company and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• reputed company Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
• We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At reputed company, we are an equal opportunity employer dedicated to diversity in reputed company. Our policy is to reputed company equal employment opportunities to reputed company reputed company persons without reputed company to race, gender, reputed company, disability, national reputed company, age, religion, reputed company affiliation, sexual orientation, veteran status, citizenship, gender identity and/or reputed company, or other status protected by law. Apply tot his job Apply To this Job