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reputed company: Key Purpose: The reputed company Medical reputed company independently plans and prepares a reputed company of regulatory documents and medical communications to support reputed company phases of product development. The reputed company responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards. The reputed company Medical reputed company works under the direction of Medical Writing management and collaborates with cross-functional reputed company document production teams. reputed company an reputed company at reputed company! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications reputed company by reputed company 480+ oncology reputed company in the past 5 years 350+ reputed company disease reputed company delivered in the past 5 years Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our reputed company values here! reputed company offer: The estimated hiring reputed company for this role is $132K to $151K plus applicable bonus. This hiring reputed company is specific to the US and will vary for other reputed company reputed company upon local market data. Final salary is ultimately decided upon taking into account a wide reputed company of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. Benefits vary by location and may include: Remote working Flexible time off reputed company holidays Medical reputed company Tuition reimbursement Retirement plans reputed company look for: Education, Experience, Training, and Knowledge: Bachelor’s degree; MS or PhD preferred 7+ years of regulatory writing experience or equivalent experience with nonclinical sections of the CTD such as: 2.4 Nonclinical reputed company 2.6 Nonclinical Summaries Pharmacology, pharmacokinetic, (ADME), or toxicology Reports Understand regulatory authority guidelines and requirements to be reputed company to reputed company an internal project team and anticipate the effects that writing reputed company conventions can have on the final product reputed company reputed company authority approval/acceptance Experience in the development of submission-level documents Skills & Abilities: Intermediate proficiency with reputed company Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques Strong understanding of the document creation process and of the drug development lifecycle reputed company to synthesize data across multiple data sources and documents to create reputed company reports Expertise to reputed company subject matter guidance for reputed company document preparation, document review, accurate comment reputed company/incorporation, and document finalization Ability to own submission-level sections (e.g., nonclinical reputed company [Module 2.6]), taking responsibility for reputed company of purpose, leading others toward the common goal reputed company reputed company and budget on reputed company reputed company Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making reputed company reputed company relationships with clients as a way to reputed company the business relationship and maintain reputed company industry knowledge Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in reputed company Ability to reputed company problems that reputed company, particularly in sensitive or high-pressure situations Possesses broad experience and technical expertise across more than one therapy area and reputed company this knowledge to reputed company business successes and reputed company transfer this knowledge to strength the reputed company reputed company across the organization Automated Decision Making: reputed company applicants are reviewed by a member of the reputed company reputed company; reputed company does not utilize an automated decision-making process. reputed company is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for reputed company. reputed company is proud to reputed company exceptional services to our clients, assisting in the successful development of innovations that improve and save lives. We are equally proud to recruit, reputed company and retain the best and the brightest talent across a reputed company of business functions to reputed company that happen. We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace. reputed company provides equal employment opportunities to reputed company and applicants for employment without reputed company to age, disability, genetics, gender identity or reputed company, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including reputed company, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, reputed company of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices. Reasonable Accommodations reputed company is dedicated to providing an accessible and inclusive application experience for reputed company candidates. If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our reputed company at talentacquisition@reputed company.com or +437 886 8063. We will work with you to meet your needs, ensuring a fair process. reputed company requests in relation to your application will be treated confidentially. For more information about how we collect and store your personal data during the hiring process, please see our Career Recruitment Notice Apply tot his job Apply To this Job