Senior Manager, Scientific Communication Operations
About The Position
Corcept is seeking a Senior Manager, Scientific Communications Operations to support the development of high-quality documents for the Medical Writing and Publications groups within the Clinical Development team. This role involves rigorously confirming the accuracy of data and text against validated 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. Corcept has been focused on the science of cortisol for over 25 years, with commercialized treatments and advanced clinical trials for various diseases. The company is headquartered in Redwood City, California.
Requirements
- 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)
Nice To Haves
- 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
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
Benefits
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
