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Regulatory & Medical Affairs - Project Manager

Posted 20 days ago

  • Expiry Date: 19 December 2022
  • Referral:

Job Description:

The position is Hybrid (50% on-site)

  • The manager of Document Management will be responsible for the 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 the 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 ensuring 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.

Minimum Qualifications:

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

  • 5 years of previous experience in the 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 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.