Mirrai Careers

Senior Manager, Scientific Communication Operations

Corcept Therapeutics

United States Full-time Posted 2w ago
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For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.  Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com. The Senior Manager, Scientific Communications Operations will support the development of high-quality documents (clinical regulatory documents and publications) for the Medical Writing and Publications groups within the Clinical Development team. This role will rigorously confirm the accuracy of data and text relative to validated data source files, particularly clinical data. The Senior Manager will also meticulously assess documents for editorial quality, consistency, formatting, and compliance with established style and document standards. Responsibilities: * Perform a quality check (QC) of clinical regulatory documents and publications prior to their approval: proofread documents for clarity, consistency, grammar, punctuation, formatting, hyperlink and bookmark functionality (as appropriate); perform data verification, cross-referencing, fact-checking, and general quality assessments of documents. Clinical regulatory documents may include clinical study reports, clinical study protocols and amendments, Investigator’s Brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs), and other regulatory submission documents. Publications may include manuscripts and congress abstracts and presentations (posters and slides for oral presentations) * Ensure documents comply with company, industry, or journal/congress-specified style guides and templates, and consistency within a document and across related documents * Work collaboratively with internal and external medical writers, regulatory publishers, and project team members to deliver high-quality documents in a timely manner * Manage QC/editorial timelines and communicate with other members of the Medical Writing and Publications groups and stakeholders outside of the Medical Writing and Publications groups to maintain awareness of expectations, milestones, and deliverables * Maintain records/archive for completed documents * May manage QC specialist contractors, as needed * Develop, enhance, and implement policies, procedures, and processes necessary to achieve organizational objectives and ensure compliance with Corcept and external (e.g., government, institutional) regulations Preferred Skills, Qualifications and Technical Proficiencies: * Proven ability to communicate in clear, concise English in both written and oral forms * Able to prioritize tasks, work simultaneously on multiple projects and complete high-quality documents according to tight timelines and shifting priorities and business needs * Strong attention to detail, for maintenance of consistency, grammar, syntax, logical flow, and scientific accuracy (fact-checking) * Familiarity with American Medical Association (AMA) style * Strong proficiency with Microsoft Office (Word, Outlook, Excel, Powerpoint). EndNote, and Adobe Acrobat * Familiarity with electronic document management systems (eg, Veeva Vault, Box, Sharepoint) Preferred Education and Experience: * 8 years of relevant industry experience as a QC editor/specialist, medical writer or copyeditor * Knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and other relevant regulatory rules and guidelines The pay range that the Company reasonably expects to pay for this position is $144,790-$175,550; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.  #LI-Remote  Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.  Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.  Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

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