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We are looking for a Medical writer and Regulatory Affairs associate.
Primary function of the position:
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

In this role you will have responsibility for laboratory tests, preparation of working samples with advanced equipment under GMP and GDP procedures, producing results and in addition, any role related to the ongoing efficient functioning of the laboratory Our QC Analyst: Performs moderately complex tests and analyses to assure that products comply with established specifications Carries out calculations and prepares documentation that shows the results of tests performed Enters basic data into log books or computer databases. Performing and monitoring routine testing using laboratory instruments Recognizing problems during the analysis Supporting laboratory housekeeping, environmental and safety initiatives

We are looking for an experienced Research associate with deep research skills to join our team.
Responsibilities:
Plans, conducts and communicate laboratory research studies focusing on target, biomarker and drug discovery
Join a multidisciplinary team of professionals in biology, chemistry, software, AI, and clinical fields.

Required Analyst
Job Description:
A clinical-stage drug discovery and development company in the field of cancer immunotherapy. In line with our business model to enter into collaborations for their internally discovered, novel therapeutic candidates at various stages in research and development, the company is seeking an Analyst in support of its partnering efforts.
Reporting to the SVP Strategic Collaborations, the Analyst will lead competitive intelligence (CI) and business analysis activities to support BD and corporate objectives. She/he will be responsible for supporting aspects of competitive analysis and other activities relating to partnering efforts.
Constantly monitor the pharma and biotech space and gather competitive intelligence from various sources including company portfolios, preclinical and clinical activities, scientific data, partnerships, deal structures and terms, and other relevant intelligence
Perform analyses and provide insights into competitive landscapes, industry trends and perspectives, market developments, product developments and positioning, as well as other intelligence in support of our BD&L and R&D efforts
Provide regular updates to our management and functions
Develop Target Product Profiles for our development candidates in close collaboration with R&D teams, and build forecast models based on epidemiological data as well as customer/patient segmentation, pricing and access assumptions
Identify potential collaboration partners for various pipeline opportunities
Work closely with our R&D community and drive the preparation of materials surrounding the companys pipeline programs for internal presentation to management and also to potential partners
Contribute to the creation of valuation models and financial valuation of business development opportunities against partnering scenarios.