Senior Manager, Scientific Communication Operations

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.

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 Applicants must be currently authorized to work in the United States on a full-time basis.