Medical Writer, FDA Regulated Products / Consultant

FDA Regulated Product Medical Writer - Consultant Professional Excellence • Expertise in FDA regulated product development • Expertise in ex-US drug and device development a plus • Experience in writing and reviewing regulatory submissions, such as Pre-INDs, INDs, CTDs, ODDs (FDA and EMA), and white papers. Experience with CMC writing (FDA and EMA) is preferred • Understands the client’s problem; conceptualizes how to solve it and achieve task objectives • Contributes scientific and innovative thinking • Contributes significantly to a high-quality work product acceptable to the senior consultant, on time and within budget • Effectively manages deadlines and multi-tasks • Engages actively in publishing of articles • Performs literature reviews • Demonstrates excellent communication skills – written and oral • Communicates directly with clients when directed by the project leader • Works well in a team environment Teamwork • Participates in business development and expansion of existing business. • Promotes and demonstrates collegiality with all firm members. • May be responsible for the preparation of project plans; defines assignment of tasks. • If a project manager, responsible for the management of project budget; manages billability, monthly invoices; oversees the quality of work delegated to others. • Participates actively in meeting practice marketing goals • Participates in the training and development of junior staff • Models, promotes and demonstrates collegiality with all firm members Personal Growth and Development • Maintains current scientific knowledge by initiating the appropriate internal or external educational/learning pursuits • Ensures personal development goals are in place and carried out in agreed timeframe Required Education and Skills • PhD in a life science or related field of study • Minimum of 10 years relevant experience • Excellent communication skills, both written and oral. Technology Proficiencies • Strong working knowledge of MS Office products including SharePoint, Adobe Acrobat Pro, and eCTD publishing software Job Type: Full-time Benefits: • 401(k) • 401(k) matching • Dental insurance • Health insurance • Life insurance • Paid time off • Vision insurance Work Location: Remote Apply tot his job