OncoSec is Hiring We are looking for innovative, results-driven leaders to join our team. We offer a collaborative work environment, a strong company culture and professional development opportunities. Scientific Writer Scientific Writer | Full Time Position Reports to: Director of Corporate Communications Summary OncoSec Medical is looking to add a scientific writer to the team. This person will support the Director of Corporate Communications and liaise with management and the clinical development team to create compelling content for the company collateral materials (including the website), in addition to articles for other various media properties. This person is a creative thinker who possesses the skill of translating complex scientific concepts into thought-provoking, consumer friendly content. If you’re a forward thinker, and will thrive in an innovative company that is constantly pushing its creative edge, this role may be for you. Education A Bachelor’s or Master’s degree in either a scientific discipline (e.g. engineering, physics, biology) or a writing-related field (e.g. journalism or English) and demonstrated interest in medical science/engineering. Experience 3+ years writing professionally. Candidate should have a scientific background (preferably in the oncology space). Skills & Abilities Understanding of FDA and international regulatory and standards requirements. Excellent written and verbal communication skills. Experience in writing content for the web. Experience in communication via social media. The ability to effectively communicate technical research to a broad and diverse audience including clinicians, scientists, and the general public. The ability to quickly grasp complex technical and scientific concepts. Ability to work in a fast-moving, demanding and changing environment. Solutions oriented, proactive and positive attitude. Proficiency in Microsoft Word, Excel, and PowerPoint. Ability to work to deadline, prioritize projects. Strong attention to detail. Duties & Responsibilities Write/edit research reports, papers, web/social media content, and other scientific communications as required. Create article ideas and draft content for company blog. Create content to support public relations and investor relations campaigns. Write/edit peer analysis reports. Monitor completive landscape and provide regular competitive analysis reports. Provide support on operational, strategy / business document updates as required. Write/edit other business documents and articles as required. Consult with subject matter experts and team members for concurrence on content changes. Provide grant administration support. Ensure content is compliant with Securities and Exchange Commission policies and regulations. Please send your CV/Resume in Microsoft Word or Adobe PDF format to: Careers@OncoSec.com | Subject Line: Scientific Writer Manager, Regulatory Affairs Manager, Regulatory Affairs | Full Time Position Reports to: Executive Director of Clinical Development Summary The Manager of Regulatory Affairs will support OncoSec in its ability to market its therapeutic products throughout the development life cycle by interacting with Regulatory Agencies, facilitating regulatory activities, preparing regulatory documentation and coordinating company-wide interactions. This individual will be responsible for correct and timely submission of regulatory related documents, while providing appropriate regulatory knowledge and advise, and ensuring that OncoSec operates within government regulations. The Manager of Regulatory Affairs will work closely with the Executive Director of Clinical Development and VP of Regulatory Affairs in planning and coordinating all regulatory submissions and activities from pre-submission to approval of product/application. They will be responsible for assessing regulatory requirements and overseeing editing and publishing of final submissions to meet these requirements. This position will provide regulatory and technical expertise into the Company’s development plans of its product candidates. Education Bachelors, Masters or Doctorate degree in a scientific or technical discipline Experience 5+ years regulatory and clinical experience in pharmaceutical industry – additional experience with medical devices (IDE clinical trials and PMAs and CE Mark procedures and policies) is beneficial but not necessary. Skills & Abilities Experience with FDA and international regulatory and standards requirements. Proficient knowledge of FDA regulations (including labeling regulations) and regulations outside the US in licensing biologics and medical devices preferred. Experience with EU submissions and MDD regulations. Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US strongly preferred. Ability to work in a fast-moving, demanding, and changing environment. Ability to function well as a member of the team and build relationships between RA and other areas of the organization. Ability to effectively manage multiple projects and priorities. Excellent negotiation skills, and written/oral communication skills. Strong attention to detail. Proficient computer skills, including Microsoft Office Suite. Regulatory Affairs Certification (US or EU) preferred. Duties & Responsibilities Serve as a Regulatory Expert to guide OncoSec on regulatory related issues, including for INDs, NDAs, PMAs, IDEs and 510(k)s throughout the product life cycle. Represents the regulatory interest of the Company by meeting with regulatory agencies. Provides regulatory advice internally to ensure compliance with FDA regulations. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays. Lead preparation of FDA and EU regulatory submissions including original design dossiers, technical files and recertification submissions, amendments, and supplements for investigational products and product changes. Provide regulatory affairs strategic and tactical support for clinical studies including pre-market and investigator-initiated studies. Participate in product development project teams and provides advice and direction on registration requirements. Participate as a primary regulatory reviewer for OncoSec’s promotional materials. Will train staff in the preparation of documentation for regulatory review in technical areas in cGMPs, and performs regular evaluations. Perform regulatory responsibilities independently with a minimal level of guidance and supervision. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Please send your CV/Resume in Microsoft Word or Adobe PDF format to: Careers@OncoSec.com | Subject Line: Manager, Regulatory Affairs Electrical/Electronic Engineer Electrical/Electronic Engineer | Full Time Position Reports to: Director of Engineering Education BSEE, MSEE or equivalent Experience Minimum 6 years engineering experience. Skills & Abilities Experience developing products from concept to manufacturing. Medical device development experience required. Familiarity with firmware development for embedded microcontrollers. Working knowledge of electrical, mechanical and software design. Familiarity with CAD tools for electrical design. Familiarity with firmware development for embedded microcontrollers. Understanding of regulatory requirements such as FDA, CE, UL and ISO. Understanding of DOE, FMEA and Risks & Hazards requirements. Experience with programmable logic coding. Experience generating product development documentation (plans, schedules, specifications) preferred. Experience with product and process validation. Knowledgeable in production related statistics and problem solving skills. Experience generating product development documentation (plans, schedules, specifications). Experience developing products from concept to manufacturing. Experience with process flow and cost reduction measures. Excellent teamwork skills required. Excellent written and verbal communication skills required. Experience using Altium Designer a plus. Proficient with standard Microsoft Office tools. Duties & Responsibilities Design, test, and document medical device electronic circuits. Apply electrical theory, electrical testing procedures and related knowledge to layout, build, test, troubleshoot, repair and modify developmental and production equipment. Provide conceptual, outline and detailed design for complex electrical engineering solutions. Brainstorm new ideas and create new designs with the engineering team. Operate computer-assisted engineering and design software and equipment to perform engineering tasks. Confer with engineers, customers, and others to discuss existing or potential engineering projects and products. Plan and implement research methodology and procedures to apply principles of electrical theory to engineering projects. Provide input into project quality plan and implement quality practice in all projects. Prepare feasibility studies, technical reports, specifications and other written documents for complex engineering solutions. Prepare specifications for purchase of materials and equipment. Maintain awareness and control of project cost, quality, scope, and schedule to ensure on time delivery of the project within budget. Review documents change orders and engineering plans. Facility and Equipment Qualification/Validation. Verify, validate and document product designs. Provide Engineering support for other departments as necessary. Complete other engineering duties as assigned. Please send your CV/Resume in Microsoft Word or Adobe PDF format to: Careers@OncoSec.com | Subject Line: Electrical/Electronic Engineer Top Download our Investor Overview: Name: Email * Phone: Subscribe to Our Newsletter. Yes! I'd like to hear about new progress and breakthroughs at OncoSec. Subscribe to Our Newsletter: Be the first to hear about new progress and breakthroughs at OncoSec. If you want to submit this form, do not enter anything in this field SUBSCRIBE !