Safety Services Project Leader

Parexel Townsend , TN 37882

Posted 3 weeks ago

Great home-based opportunity to join Parexel's best in class Global Medical Sciences Team as a Safety Services Project Leader (SSPL)/(Drug Safety Project Manager)! This highly visible role combines your drug safety, post-marketing, and product launch experience with your project management expertise.

When serving as the Functional Leader, the SSPL will provide leadership, management, general oversight and direction for Medical Safety Services projects, including but not limited to medical monitoring, clinical and post -marketing pharmacovigilance. The SSPL will also be responsible to ensure client satisfaction, project team management and communication, quality, adequate resource planning and allocation, and financial performance. The SSPL will serve as the primary point of contact and communication between the Parexel Project Leader, the Sponsor team and Medical Services worldwide and, with the Global Lead Physician (GLP) be accountable for performance of the entire Medical Services team on that project.

As a Functional Leader, the SSPL will be responsible for management, general oversight and direction for Safety Services projects, including medical monitoring and clinical and post - marketing Pharmacovigilance (PV) projects. The SSPL will also be responsible to provide input, advice and direction for project resource planning and allocation, and overall Safety Services project team management. The SSPL will also be a point of communication contact and liaison with internal and external stakeholders, strategic planning teams and project review teams including Quality, financial performance and customer feedback. The SSPL will be responsible for consistent and complete communication between all members of the Worldwide Safety team.

In addition, in the functional lead role, the SSPL will be responsible to provide input, advice and direction for resource planning and allocation working closely with the global resource planning office, project team management, stakeholder liaison, strategic planning and reviews:

  • Management, support, direction, coordination and planning for any medical and other pharmacovigilance (PV) related activities, including oversight of and contribution to PV consulting projects.

  • Strategic input, including providing subject matter expertise for Safety Services in the planning and setup of projects, including costing, budgeting, resourcing, workflow and process design and analysis.

  • Provide training and mentoring to other, less experienced SSPLs and Safety Operations Staff.

  • Timely contribution to and strategic input and review of proposals (RFP), and contracts as required.

  • Liaison with internal (e.g. business operations, account management, Parexel Consulting) and external stakeholders (e.g. clients, third party vendors, health authorities).

  • Represent Medical/Safety Services if and when required for internal and external matters.

  • Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate.

  • Contribute to Medical and PV Operations resource planning and strategy.

  • Contribute to the costing of Medical and PV Operations projects, including the review of and improvement of performance metrics and costing tools.

Qualifications

  • Attend and lead client meetings, and bid-defense meetings.

  • Provide timely input and feedback to process improvement.

When serving as the Project Leader on standalone projects, the SSPL is independently responsible for all Project Leader tasks and deliverables according to SOPs on assigned projects including:

  • Attend and lead Bid Defense Meetings along with the BD team

  • Develop and maintain a formal project plan with all key milestones, budgets, and resources assigned to specific tasks and outcomes. Define metrics for reporting against plan.

  • Ensure that all standard project systems and tools are set up correctly and functioning appropriately.

  • Implement operational strategy as defined in the project plan and makes changes to the plan to ensure desired results.

  • Proactively solve problems in collaboration with the client and project team.

  • Close out of all project activities upon project completion; perform financial reconciliation and system closeout.

In this capacity the SSPL will be responsible for the financial management /administration of the function-led projects according to Corporate Business Operating Procedures to include:

  • Maintenance of a project plan

  • Monthly revenue recognition and forecast activities

  • Invoicing according to contract -service and pass through cost

  • Monthly control/adjustment of time reported

  • Project close out activities WW (in cooperation with Project Analyst)

  • Provide project information to Project Analysts

  • First point of contact for the client for all financial related issues

  • Coordination/management of project team

In activities involving project management, the SSPL will be acting as the Medical functional lead working with the overall Parexel PL or as the PL if a the project is a function-led Medical project, to ensure that projects run on time, on budget, and in accordance with client contract, SOPs, quality standards and regulatory guidelines.

Projects may involve the following tasks:

  • Clinical trial safety management

  • Clinical trial medical monitoring

  • Clinical trial cumulative and/or per-patient data review

  • Post-marketing PV

  • Any other activities as required by lifecycle drug safety services.

The SSPL will be required to maintain PV knowledge and knowledge of any other Medical service processes current as required by regulations and SOPs, and to document competencies appropriately in the training documentation files.

The SSPL will be the single operational point of contact in Medical/Safety Services for this communication.

To ensure success, qualified candidates should have the following qualifications:

  • Excellent knowledge of drug safety, drug development, and ability to interpret/apply global safety regulations

  • Previous post-marketing and/or product launch experience

  • Experience in evaluation of safety data and the preparation of safety reports

  • Experience w/ computer applications including database management and pharmacovigilance related systems

  • Ability to:

build effective project teams, motivate, delegate, and drive timely/quality decision-making

gain trust and confidence with a variety of clients and w/in Parexel

create a sense of urgency and take a proactive, solutions-based approach

prioritize and manage multiple, varied tasks with enthusiasm and attention to detail

thrive in a matrix environment and to value the importance of teamwork

work independently with oversight guidance

  • Customer focus, commitment to quality management and problem solving

  • Effective communication and negotiation skills

  • Budget management skills

  • Basic understanding of all aspects of project life-cycle

  • Proven track record of developing client relationships

  • Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Protection Engineer Technical Leader

Electric Power Research Institute

Posted 2 months ago

VIEW JOBS 8/28/2021 12:00:00 AM 2021-11-26T00:00 Job Title: Protection Engineer Technical Leader Location: Charlotte, NC, Knoxville, TN, Palo Alto, CA, Washington, D.C. Job Summary and Description: The role will involve working with transmission grid companies in North America and around the world to solve modern and exciting grid protection challenges. While experience with setting relays and performing coordination studies is essential, it is important that the candidate be interested in and capable of analyzing larger scale problems. These may include supporting investigations into large-scale blackouts, analyzing protection relay behavior during power swings and other transient disturbances, coordination of and interaction between generator and grid protection devices, and the impacts of inverters and decreasing inertia on protection performance. Through project experience and training the role will enable the candidate to build and develop their expertise in grid protection, protection relays and their applications, settings, and testing. The successful candidate will join a growing team performing protection R&D who are focused on tackling major protection challenges and delivering practical solutions from concept all the way through to deployment in the field. * Leads research efforts in particular scientific disciplines or technologies and participates the development and application of products and services in those areas through contractors and departmental or cross-functional teams. Applies technical expertise, and has full knowledge of other related disciplines. Develops technical solutions to complex problems which require the regular use of ingenuity and creativity. Organizes the external and interdepartmental activities ensuring completion of the project/product on schedule and within budget. May conduct research directly in complex, high impact technical or scientific fields. * Ability to apply technical knowledge to industry issues and gain input on needs from members/stakeholders and identify current and emerging technical issues. * Develops research or services opportunities of value to EPRI members that fit EPRI's mission and capabilities. This will include solving customer problems, producing insights and information vital to the members, and delivering information in a manner that members and customers can and will apply. * May provide oversight of a project team to assure technical and financial milestones are met. * Provides assistance to the EPRI sales staff in Member Services and EPRI International. * Broaden technical expertise and interface with national and international technical networks with manufacturers, consultants, and academia and research organizations. * Communicates strategies and results, written and verbal, to program members, potential members and external stakeholders through guidelines, reports, meetings, webcasts, workshops and conferences. * Manages small or medium (less complex) projects including budgets and resources Education: Bachelor's Degree in a technical field or equivalent experience required. Knowledge, Skills, and Abilities: * 5 -7 or more years of research and development project and promotional experience, including development of advanced concepts for internal research or equivalent experience. * Shows technical expertise and assumes responsibility for highly specialized technical objectives using creative imaginative solutions. * Experience in performing and/or managing research activities. * Incumbents must be able to exercise judgment, diligence, and attention to detail and demonstrate an aptitude for carrying out responsible technical assignments. * Good verbal and written communication skills. * Manages projects and may work in conjunction with a technical specialist. * Developing technical depth in 1-2 areas * Understand how work fits across EPRI programs * Typically individual contributor, may begin handling supervisory activities for lower level positions. Additional Job Information: Required Experience * Focused and inquisitive attitude towards learning about and solving power system protection challenges * Ability to investigate unusual and challenging power system disturbances, replicate in simulation, and develop novel, practical solutions which can be validated and deployed in the field * Understanding of power system faults and sequence components * Understanding of protection functions and programmable logic used in modern numerical Schweitzer, GE, ABB, Siemens relays * Experience performing power system disturbance investigations * Experience running short circuit simulations and protection coordination studies in tools such as Oneliner, PSS-CAPE, or Powerfactory * Experience with electromagnetic transient modeling and studies in PSCAD, EMTP-RV, ATP-EMTP, or Powerfactory Beneficial Experience * Experience working in transmission grid operations or planning. * Ability to pick up new protection algorithms, applications and philosophies * Participation in IEEE PSRC, CIGRE B5 or similar industry P&C Working Groups * Understanding of North American and International utility protection practices * Knowledge of wind, solar PV, battery energy storage or VSC-HVDC inverter control design and short circuit characteristics * Experience with transient stability modeling and studies in PSS/E, PSLF, Powerfactory, TSAT, or PowerWorld * Experience with programming languages and environments such as Python, CUPL, Powerscript, Matlab, MathCAD EPRI participates in E-Verify, an online system operated jointly by the Department of Homeland Security and the Social Security Administration (SSA). EPRI uses the system to check the work status of new hires by comparing information from the employee's I-9 form against SSA and Department of Homeland Security databases. Note: To ensure compliance with U.S. export controls, please indicate your U.S. citizenship or (for foreign citizens) your U.S. visa/immigration status in your resume or cover letter. EPRI is an equal opportunity employer. EEO/AA/M/F/VETS/Disabled Together . . . Shaping the Future of Electricity. www.epri.com Electric Power Research Institute Townsend TN

Safety Services Project Leader

Parexel