Job Details

Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains.Core Service OfferingsTemporary StaffingPermanent StaffingPayrollingRecruitment Process Outsourcing (RPO)Back-office ServicesApplication Design and DevelopmentWebsite Design and DevelopmentProgram/Project ManagementOur Domain StrengthWith currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors.Geographic CoverageLanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an international footprint with two country offices in Canada (ON and BC) along with three delivery centers in India—Bangalore, Indore and Hyderabad—to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse contingent workforce needs of our clients.Awards and AccoladesManpower “Premier Vendor” – 2014Kelly's “Supplier Innovation Award” – 2012Kelly's “Supplier of the Year” Award – 2012 and 2011Kelly's “Service Excellence Award” – 2010 and 2009“Stewardship Recognition” from Johnson & Johnson's (J&J) Kelly Work sense programJob DescriptionTitle: Document Control Specialist-IIILocation: Horsham- PAPV Controlled Documents is a member of the Training & Document Control Center of Excellence (TDC CoE) group within Compliance Strategy and Analytics and is responsible for development and delivery of Global Medical Organization (GMO), Office of Consumer Medical Safety (OCMS) and Dual-sector medical safety procedural documents.The Senior Associate, PV Documents is responsible for assigned deliverables to promote regulatory compliance with respect to pharmacovigilance. This involves procedural document development on GMO, OCMS, and Dual-Sector Pharmacovigilance (PV) processes and pharmacovigilance-focused regulations.The Senior Associate, PV Controlled Documents identifies and supports improvement activities for a document management department of the highest standards that may be leveraged to support other Client's organizations and sectors as appropriate by actively interacting with Client colleagues.The Senior Associate, PV Documents supports projects that ensures document development requirements are identified and aligned to overall strategic objectives.The Senior Associate, PV Controlled Documents may participate on functional teams for projects in order to support achieving program deliverables.Support the development and delivery of assigned procedural documents by actively partnering with GMO/OCMS functional areas, other partners and Medical Safety Organizations as needed to ensure that desired outcomes and deliverables are met.Support procedural document initiatives and projects of moderate complexity.Facilitates Cross-pharma Reviews and Impact Assessments as needed.Provide Audits and Inspections support and litigation request support.Facilitate Procedural Document Committee meetings.Other duties as assigned.QualificationsThe position requires the ability to:Manage multiple, moderately complex procedural document assignments within timeframes with minimal guidance.Communicate, both verbal and written, and collaborate effectively and professionally with internal colleagues and external partiesLead committee meetings and projects/initiatives professionallyFoster consensus and make decisions independently appropriate to subject matter and responsibilitiesExperience in procedural document development or quality role for a minimum of 5 years preferably in pharmaceutical industryDemonstrated experience in Electronic Document Management System(s)Proficient in Microsoft Word, PowerPoint, Excel, and Visio.Pharmacovigilance knowledge or experience preferred.Demonstrated strong Credo values.Excellent oral and written communication skills, including formal presentation skills.Commitment to providing excellent customer service.Ability to work independently and successfully manage multiple priorities simultaneously.Ability to establish successful working relationships with staff at all levels within the organization during the development of procedures.Additional InformationThanks and RegardsDishant Nagar703-480-4117#J-18808-Ljbffr