*** NEW REQUIREMENT *** MEDICAL WRITER REQUIREMENT #13-00617 RECRUITER: MICHELLE ASHEN JOB LOCATION: LAWRENCEVILLE, NJ JUNE 25, 2013 Description and Responsibilities: Responsible for publication-related resource decisions and for coordinating the efforts of team members, both internal and external, in order to deliver projects according to plan. To set and continually manage project expectations with team members and other stakeholders and to identify and resolves issues and conflicts within the project team. To plan and schedule project timelines and milestones and to track project milestones and deliverables. To enable a consistent approach to vendor management, the Publications Operations team will serve as the principal medical interface with medical communication vendors and global procurement. They will track and manage medical communication budgets, ensuring continued transparency into medical communication spend. Oversee transactional level services, to include contract and invoice routings/approvals. Support appropriate usage of publication management tools. Generate performance scorecards, metrics and tracking reports and communicate to team members and stakeholders. This particular role will support HQ and U.S. virology programs. • Proven experience leading diverse teams through direct and indirect influence • Proven ability to work with and manage within a matrix environment • Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team • Worked successfully in a cross-functional project team • Ability to facilitate discussions and decision-making with cross-functional and cross-cultural team members, ability to influence and negotiate appropriate solutions, experience in project managing multiple priorities under tight time constraints, and proven ability to establish strong stakeholder relationships • Proven experience identifying resource needs and assigning individual responsibilities, revising as appropriate to meet changing needs and requirements • Experience managing third-party vendors • Participate in relevant filing sub-team(s) and ensure effective planning and management of timelines for all components of assigned documents • Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells • Collaborate with project team to respond to health authority questions and requests • Provide departmental management with adequate information to assess resource needs • Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator’s Brochure) ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members • When assigned as lead writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions Required Skills: • A MS, MBA, PhD, PharmD, or other advanced degree, plus at least 3-5 years of experience within the pharmaceutical or related healthcare industry • Medical communication agency experience preferred • Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals • Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities • Working knowledge of a document management system and basic knowledge of document publishing process • Analyzed and interpreted complex data from a broad range of scientific disciplines • Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Michelle: michellea@alphaconsulting
Posted on: Tue, 25 Jun 2013 19:56:23 +0000
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