Senior Technical Project Manager

Company Name:
Questcor Pharmaceuticals, Inc.
Questcor Pharmaceuticals, Inc. is a specialty biopharmaceutical company which provides products for patients with serious, difficult-to-treat autoimmune and inflammatory disorders. We support research in a number of rare conditions, including in treatment-resistant patient populations, in which there is significant need for improved therapeutic options. Questcor was awarded Orange County Register's #1 Best Large Company of 2012 and Forbes' Magazine's #1 Best Small Company award in 2011, #7 in 2012, and #1 in 2013.
We are currently seeking a Senior Technical Project Manager .
The individual will be part of the Research and Development Group (R&D;) which is responsible for all FDA related development and also supports all non-FDA company sponsored research. The individual will manage, execute and report on research/ development programs. These programs will include for example, non-clinical, CMC, and regulatory, projects. The individual will provide project management support to members of specific project teams throughout the conduct of assigned projects.
1. Provides input into the company's studies from an operational perspective.
2. Implements approved protocols and operational plans, which are consistent with strategic corporate and R&D; objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies .
3. Works closely with Translational Research on pre-clinical studies and will provide input into the studies from a technical perspective.
4. Provides input as needed to assist the Translational Research group with coordination of pre-clinical studies to determine the pharmacology of early-stage and marketed compounds.
5. Assists with identification of CROs, academic groups, or organizations to conduct preclinical company sponsored studies (CSS) and to conduct mechanism of action (MOA)-based pharmacology studies on Questcor's compounds.
6. Assists the scientific staff on selection of vendors, including assessment of capabilities and risks via teleconferences and site visits.
7. Reviews proposals, work orders, and other contractual documents.
8. Manages and oversees external partners who conduct studies.
9. Oversees the budget and timelines, responsible for identification and escalation of critical issues.
10. Manages internal resources and timelines associated with all project activities.
11. Manages study support personnel to achieve the program goals and objectives.
12. Facilitates and leads internal and external meetings.
13. Assists with the appropriate development of all documents by vendors including but not limited to: project-specific documents required for the conduct of assigned studies.
14. Assumes primary accountability for assigned projects and ensures individual functions maintain compliance with applicable regulations, guidelines, and corporate policies for study activities.
15. Ensures the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required.
16. Ensures operational integrity of assigned studies and participates in FDA or authority inspections, as needed.
17. Develops and maintains detailed timelines and resource projections for assigned programs.
18. Provides routine status reports and updates regarding the progress of programs.
19. Able to use MS Project proficiently.
20. Ensures that plans are in place for management of all materials to support the appropriate execution of all assigned projects, including but not limited to distribution of documents, forms, supplies, equipment, laboratory supplies, and devices.
21. Prepares internal and external memos, reports, documents, and correspondence required to properly manage and document activities on the studies.
22. Ensures maintenance of project files according to applicable regulations, guidelines, and corporate policy (e.g. GXPs and company procedures).
23. Manages the day-to-day operational and tactical aspects of multiple projects.
24. Reviews deliverables across projects.
25. Minimizes exposure and risk across multiple projects.
26. Manages scope and mitigates risk across projects.
27. Ability to establish and maintain systems and processes necessary to control and report program status and activities. Ability to ensure that quality, regulatory-compliant research is conducted on time and within budget.
Job Dimensions:
To perform this job successfully, the individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Language Ability:
Ability to read, interpret and develop study protocols, reports, business correspondence, and all associated materials in collaboration with other R&D; staff or outside consultants. Excellent communication skills, including effectively present information and respond to questions from project teams, external vendors and customers.
Computer Skills:
Microsoft Project, Microsoft Word, Microsoft Excel, Microsoft Sharepoint, Internet software, E-mail, Database software.
Required Qualifications:
Ph.D. in a life sciences discipline
PMP certification preferred
Minimum of five years' experience successfully managing programs, preferably in a technical setting
Desired Characteristics:
Ability to exercise judgment and determine appropriate action
Ability to work independently and to adapt to rapidly changing environments
Ability to manage deadlines and scientists
Ability to manage external outsourcing partners
Strong communication and organizational skills
Proven ability to recommend solutions to a variety of technical problems of moderate scope and difficult complexity
Questcor provides competitive salary, bonus and a full range of benefits (100% paid for employee & 90% paid for dependents), 401(k), ESPP and restricted stock awards.
Questcor is an equal opportunity employer
Date: 2014-03-21
Country: US
State: MD
City: Ellicott City
Postal Code: 21043
Category: Clinical Research
Job Type: Regular Full-Time

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