Job Description :
Sr Medical Writers Location: 100% Remote (2 video interviews) Duration: 12-18mth+ NO: OPT, H1, GC-EAD CANDIDATES MUST LIVE WITHIN 200 MILES OF BOSTON, MA. 4-5 years experience Broad range of exp Protocols and CSRs At least 5 years of regulatory medical writing experience in a CRO or pharma environment. Experience as lead writer on protocols, CSRs, investigator brochures is required Experience as a lead writer on IND in eCTD format and FDA meeting briefing documents is preferable. Experience doing QC, source data verification, and editorial reviews is a plus Description: Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external PPDs. Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external PPDs, supporting and enabling effective and efficient communication that results in operational excellence. Independently researches, writes, and edits clinical study reports, study protocols and standard response documents. Produces complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and dossiers. Provides senior review of documents and training/mentoring for other writers. -Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions. -May manage several long-term projects concurrently. -Represents Medical Writing in Project Launch Meetings, Review meetings, PPD audits, bid defenses, and capabilities presentations. -Establishes and develops PPD relationships; independently initiates and leads interactions with PPDs. -Assists with business development and development of budgets and proposals. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience. Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous Knowledge, Skills and Abilities: -Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills -Strong project management skills -Excellent interpersonal skills including problem solving -Strong negotiation skills -Excellent oral and written communication skills with strong presentation skills -Significant knowledge of global, regional, national and other document development guidelines -In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc. -Great judgment and decision-making skills -Excellent computer skills and skilled with PPD templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) Working Conditions and Environment: Work is performed in an office environment. Exposure to electrical office equipment. Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.