Dossier Managers execute, through use of standards and tools, designated operational tasks including:
1. Monitoring document receipt, following up with contributors and translations management (where applicable) for assigned submissions.
2. Dossier Technical build and publish. Members of this team hold responsibility for defining and upholding Client dossier execution and publishing standards and practices to meet agency requirements globally.
3. Submittal to HA or dispatch to the applicable Client country office / Hub Submission Manager, conforming to regulatory submission milestones and applicable regulatory obligations.
4. Given the global span of the organization, critical features of this role are the ability to successfully interface with multiple cultures and functions from within Client, to recognize, and exploit opportunities to use scale, cloning and repurposing dossiers for worldwide markets where feasible.
5. The Dossier Manager may be assigned to additional work where they have experience and expertise, as needed, to meet increased business demands.
6. Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanour.
7. Engages Submission managers & Publishing leaders, business suppliers, and other key regional representatives as appropriate, to agree on process and activities for opportunistic re-use of submission documentation for multiple national markets.
8. Leads the interpretation of regulatory guidelines to produce business requirements for publishing and ensure that those publishing requirements are implemented.
9. Provides the global DM pool with a point of escalation for regional knowledge to ensure timely delivery, quality and accuracy of work.
10. Manages own time to meet objectives.
11. Provides guidance to and leads moderately complex submission and process improvement projects, making decisions independently.
12. Work with the team managers to effectively forecast and manage project specific resources utilizing flexible resourcing as normal business practice.
13. Considered a technical resource within the group.
14. Regularly takes informal leadership role during Work Team meetings to facilitate agreements and move the group toward its goals.
15. Demonstrate experience of influencing through data storytelling, with the ability to use data to inform on an idea, concept, or insight.
Accountabilities specific to Dossier Managers:
1. Adhere to FDA regulations 21 CFR 312 and 21 CFR 314, coordinate US regulatory compliance submissions which are driven by relevant Event and/or Calendar to ensure Client’s legal obligation.
2. Monitor and verify Suspected Unexpected Serious Adverse Reaction (SUSAR) arising from clinical trial, report to Regulatory Authority within agreed timeline to protect patient’s safety. For death/life threaten SUSAR reports, notify FDA no later than 7 calendar days after Client’s awareness. For other SUSAR reports, notify FDA no later than 15 calendar days after Client’s awareness.
3. Submit investigator package (FDA 1572 form and CV of the principal investigator) to Regulatory Authority within 30 days to guarantee patient’s safety and right when new investigator added in the clinical trial study.
4. Coordinate and notify Regulatory Authority of any Advertising and Promotional Labeling materials on or before its Date of First Use (DOFU) to protect public health by assuring the prescription drug information is truthful, balanced and accurately communicated in accordance with existing regulation and present guidance.
5. Manage aggregate reports to deliver the safe, effective products to market: Submit annual brief report of the progress of the investigation for open Investigational New Drug application; Provide safety updates of post-marketing drugs for the specific reporting period to the Regulatory Authority to fulfil safety reporting obligation and keep good pharmaceutical practice.
Qualifications:
1. B.S./B.Scs. is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
2. Associate: Advanced English language required. Sr. Associate / Manager: Advanced to Fluent English language required. Multilingual skills desirable.
Technical Skills:
1. Advanced Microsoft Office Suite skills.
2. Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards, including fluency with publishing and Document Management tools.
3. Experience with building & publishing a full paper and electronic submission.
4. Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
Functional Skills:
1. Demonstrated coordination of activities in a highly regulated environment.
2. Proven aptitude in project management and logistics.
3. Demonstration of experience working in a challenging customer service environment.
4. Proven experience managing or delivering through others in a team environment.
5. Relevant experience in electronic submissions build and publish within the Pharmaceutical Industry.
6. Formal training in technical tools.
7. Knowledge of drug development process.
8. Understanding of applicable publishing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers.
9. Ability to work on multiple highly complex projects simultaneously.
10. Strong knowledge of the drug development process, regulatory sciences, and submission management & publishing.
11. Ability to operate seamlessly and influence/mentor direct and indirect reports, as well as across organizations.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Writing/Editing, Advertising, and Other
Industries
* Pharmaceutical Manufacturing
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