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PPD

Sr Manager Medical Writing

Effectively manages medical writing projects and operations ensuring high-quality and timely delivery of medical/scientific writing products to internal and external clients. Provides substantive advice on strategy, regulations and industry best practices demonstrating subject matter and therapeutic area expertise. Manages the business development and pricing functions of projects for clients or alliance
partners and contributes substantially to business development. Develops, mentors and guides the medical writing staff and management team.
imum Required Education and Experience:8 years of experience managing and directing complex medical writing projects required to include 2 years of management responsibilityRelevant experience working in the pharmaceutical/CRO industry is preferredAdvanced degree (PharmD, PhD, Masters) preferredAdditional qualifications in medical writing (AMWA, RAC, etc.) is advantageousRequired Knowledge, Skills and Abilities:Broad range of medical writing project experience and knowledge of global regulatory requirements for clinical trials, marketing authorization and late phase procedures Knowledge of global/regional medical writing/regulatory requirements for clinical trials, marketing authorization and late phase proceduresKnowledge of budgeting and forecastingAbility to manage people including performance management, training, mentoring, directing and supervising work and motivating employeesStrong project management skills, including the ability to plan and manage projects, create and modify budgets, develop timelines, allocate resources, and forecast departmental workloadGood presentation skills for use in client presentationsInnovation in developing new ideas related to Medical Writing, including process improvementsExcellent medical writing skills, including grammatical, editorial, and proofreading skills, and the ability to interpret and present complex dataAbility to effectively communicate with potential clientsAttention to detail and qualityExcellent interpersonal skills including problem solving, judgment, and decision-making skillsExcellent understanding of computers and their applicationsEffective oral and written communication skillsOrganizational and planning skillStrong negotiation skillsSelf-motivated and adaptableAbility to work independently on own initiative as well a part of a teamMental skills required in areas of: numeracy, language, analytical, investigative, verbal and written communication, attention to detail, customer contact, multiple project handling, reading and interpretation of dataExcellent knowledge of relevant ICH and other global regulatory and document development guidelinesIn-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc.Good visual acuityColor recognition (red, yellow, blue)Good manual dexterityPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

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