Job Number: 21005764
DOCUMENT PROJECT MANAGER
Hybrid (50% Onsite).
- 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.
- 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.
- 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.
- 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.
- 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.).
- Ensure the coordination and execution of timely and efficient internal review and approvals of Risk Management regulatory report deliverables.
- 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.
- Responsible for the quality of output documents and ensures content meets appropriate editorial standards (style, formatting, document requirements, etc.).
- Provide monthly reports on Risk Management reporting activities.
- 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.
- Additional Risk Minimization as subject matter expert.
- Back-up for Manager Document role as required.
- Support internal audit and regulatory inspection activity as needed.
- Monitor GRM mailbox.
- Assist with ad hoc projects and additional tasks as assigned.
- 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.
- 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.
- Gradual ability to analyze Risk Management operational data and in turn recommend strategies and prepare written reports and presentations.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02046
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE