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Job Requirements of Medical Writing Operations Manager III:
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Employment Type:
Contractor
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Location:
Princeton, NJ (Onsite)
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Medical Writing Operations Manager III
Careers Integrated Resources Inc
Princeton, NJ (Onsite)
Contractor
Job Title: Medical Writing Operations Manager III
Job Location: Princeton, NJ (Remote)
Job Duration: 12 Months (possibility of extension)
Payrate: $73.45/ hr on w2
Job Summary:
Job Location: Princeton, NJ (Remote)
Job Duration: 12 Months (possibility of extension)
Payrate: $73.45/ hr on w2
Job Summary:
- The primary responsibilities of a Manager, Medical Writing Operations, include, but are not limited to, providing project management, editorial, and QC assistance with the preparation of scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics; leading or providing support to Medical Writing process improvement initiatives; managing the development and update of SOPs, templates, and other guidance documents.
- Manages and supports projects in accordance with established processes and SOPs, meets timelines, and resolves challenges; effectively communicates and collaborates across R&D functions.
- Provides editorial assistance, including editing and formatting in alignment with the Client R&D Authoring Style Guide, with the preparation of scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics
- Provides project management support to medical writers with the preparation of scientific and regulatory documents, including the tracking and compilation of appendices for clinical study reports.
- Performs ad hoc QC requests on R&D documents while working in close partnership with members of R&D functions
- Leads or provides support to Medical Writing process improvement initiatives in collaboration with other medical writers and relevant cross functional R&D groups
- Manages the development and update of medical writing SOPs, templates, and other guidance documents.
- Bachelor’s degree, preferable in life sciences, professional/technical writing or related field, with a minimum of 5 years of pharmaceutical/biotech experience in the regulatory document preparation/management arena required.
- A solid understanding of the clinical development process and the principles, concepts, practices, and standards of pharmaceutical project management.
- Knowledge of and/or ability to quickly assimilate US, ICH, and international regulations, requirements, and guidance associated with scientific and clinical/regulatory document preparation and submissions.
- Knowledge of Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation.
- Technical writing experience: ability to self-edit and improve own and others’ work to ensure readability, accuracy, consistency, and aesthetic presentation of data and information.
- Experience with authoring style guides, including providing input on making changes and improvements; familiarity with formal styles such as AMA preferred.
- Quality control experience in the preparation, review, and finalization of regulatory submissions and supporting documents, including in support of an eCTD or other regulatory documents per ICH or other applicable standards.
- Working knowledge of current electronic document management systems (e.g., VeevaVault, SharePoint) and publishing systems.
- Excellent interpersonal, organizational, written and verbal communication skills.
- Project management experience: ability to support multiple projects simultaneously, be well organized, and have strong time management skills and attention to detail.
- Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets; advanced computer skills in Microsoft Office software (including Word, Excel, and PowerPoint) and reference management software (e.g., EndNote).
- Ability to work under limited supervision, determine personal work plan, and schedule tasks and activities accordingly.
- Ability to accommodate shifting priorities, demands and timelines.
- Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.
- Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.
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