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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Project Manager

Job Description

  • Location: Summit, NJ
  • Type: Contract
  • Job #71766

Our client, a leading pharmaceutical company, is hiring a Project Manager on a contract basis.

Work Location

Summit, NJ/Hybrid

Summary

Manager of Document Management will be responsible for overall coordination and project management of local RMP submissions for overall coordination and process management related to regulatory RMP and REMS submission activities and liaise closely with Local Market Patient Safety to support local RMP submissions to Health Authorities

 

a. Manage the development of Risk Management regulatory submission documentation (including REMS modifications, sNDA REMS submissions, Risk Management Plans (e.g. local RMPs, Global RMPs and Annexes) communications, etc.) for Health Agency submission

b. Organize and appropriately document (within internal databases) the formal internal review process for Risk Management regulatory document submissions to ensure the integrity and compliance of regulatory submissions are maintained

c. Liaise with internal multidisciplinary stakeholders (e.g. Regulatory Affairs, Regulatory Operations, Safety, local affiliates and Legal) to keep track of and ensure capture of updates within risk management submissions

d. Direct as requested internal and external stakeholders and vendors to create and supply the necessary components to complete the REMS submission at hand (risk management materials, screenshots, etc.)

e. Ensure the coordination and execution of timely and efficient internal review and approvals of Risk Management regulatory report deliverables

f. Collaborate with other internal departments to obtain information and data as needed to support the creation and development of FDA REMS deliverables and Risk Management deliverables upon request

g. Responsible for the quality of output documents and ensures content meets appropriate editorial standards (style, formatting, document requirements, etc.)

h. Provide monthly reports on Risk Management reporting activities

i. As required, contribute to and support the development, implementation, and optimization of RMP tracking including Additional activity tools, e.g., RMP Tracker/RIMSy, CARA/PRISM, Veeva Vault

j. Additional Risk Minimization as subject matter expert

k. Back-up for Manager Document role as required.

l. Support internal audit and regulatory inspection activity as needed

m. Monitor GRM mailbox

n. Assist with ad hoc projects and additional tasks as assigned

 

Qualifications:

• BS/BA required, advanced degree in healthcare science, public health, or applicable fields, a plus

• 5 years previous experience in Pharmaceutical Industry (REMS Operations, EU-RMPs, Medical Communications, Regulatory, or Safety/Pharmacovigilance or relevant disciplines)

• Have advanced skills in MS Word, Excel, MS Project Management and PowerPoint.

• Knowledgeable of EU regulations for Risk Management Systems

• Medical writing experience preferred for EU-RMPs

• Medical/REMS document preparation experience, a highly desired

• Risk Evaluation Mitigation Strategies (REMS) and EU-Risk Management Plan knowledge and experience, highly desired

• Experienced in project management

• Document Management experience required

 

Desired Competencies:

• Ability to independently manage multiple projects with accountability and excellent work ethic

• Proven skills in collaboration with cross-functional teams and in a team environment

• Excellent and effective verbal and written communication skills with the ability to interface with Risk Management Leadership team, interdisciplinary project teams, and external vendors

• Acute attention to detail

• Adaptive, resilient, and nimble character, yet firm and sturdy in conviction and ethics

• Highly strategic and proactively recognizes problems and foresees opportunities with a tendency to act with a solutions-driven attitude

o. Gradual ability to analyze Risk Management operational data and in turn recommend strategies, and prepare written reports and presentations

 

 

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