Provide significant brand planning assistance through the regular contributions to setting Commercial and brand strategy, making actionable recommendations grounded in insights from market research and business data.
The Manager, Sales Training will act as a liaison and coordinate efforts between Marketing and Regional Sales Managers to identify future training requirements to enhance selling skills and account knowledge to attain regional and national goals.
Provide individual and group based clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, healthcare and managed care provider settings; increase company and product awareness amongst external audiences on new advances in the management of neuropsychiatric diseases and disorders.
Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analyzes plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear objectives.
Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other company departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
The Senior Manager, Medical Writer will be responsible for writing and/or editing clinical documents (clinical study protocols Phase 1-3, investigator's brochures, and clinical study reports), regulatory documents (FDA meeting briefing package, IND clinical modules, CTD/NDA), and associated regulatory submissions.
Coordinate and oversee scale-up of the processes, process validation activities and manufacturing and troubleshooting of potential issues; coordinate research and or troubleshooting to develop new and improved chemical manufacturing processes.
The Assoc. Manager of Financial Planning & Analysis is responsible for partnering and supporting business functions in the annual budgeting, quarterly forecasting, monthly close processes and consolidated financial reporting.
Develops strategic relationships in multiple departments and at all levels to identify and seize mutually beneficial business opportunities; attends industry related meetings to advance and enhance awareness of its products and services and build industry-wide awareness and advocacy.
Provide ongoing assessment, evaluation, and communication with other company departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives are accomplished.
The Manager of Financial Planning & Analysis is responsible for partnering and supporting business functions in the annual budgeting, quarterly forecasting, monthly close processes and consolidated financial reporting this role will also support the business in any special project requests.
Lead and generate communication to/from key third party organizations on appropriate key legislative issues, as deemed necessary; coordinate regular informative mailings to allies on mutual issues of interest.
Provides measurable input regarding development of overall objective; ensures that ongoing operations, processes and programs are completed on schedule and within budget; erroneous decisions, recommendations or failure to complete assignments would result in moderate impact on customers and/or objectives.
Provide support to medical practices wishing to understand the regional epidemiology of various target neuropsychiatric conditions; execute roundtable meetings to support disease state or product specific educational needs at the local and regional levels.
Lead and execute multiple high quality integrated cross-functional project plans including development of project charters, schedules, milestones, budgets, risks, issues and resources to meet project goals; incorporate technical, resource, operational and regulatory requirements into project plans.
Support the Clinical Study Manager and/or Director of Clinical Research with vendor selection and vendor management, including the Contract Research Organization ("CRO") and other clinical study vendors (Central Lab, IVRS, Scale Management, etc.).