Senior Medical Writer Position Available In Somerset, New Jersey

Job Description:

The Senior Medical Writer (SMW) works with team members andindependently to write the content of clinical documents that mayinclude CSRs, protocols, ICFs, narratives and IBs in a variety oftherapeutic areas. Opportunities to chip in to other regulatorydocuments may be provided. The SMW tracks their own writingprojects and is responsible for adhering to regulatory guidelinesand department document standards. The SMW may also serve as leadfor a compound and may also review the work of junior/outsourcedwriters as well as review CSR-related documents (StatisticalAnalysis Plans, TFLs) to help ensure appropriate content forinclusion. As a Senior Medical Writer, a typical day may include:

Works with the clinical team, to write the content of clinicaldocuments that may include CSRs, protocols, ICFs, narratives andIBs in a variety of therapeutic areas. Opportunities to write orcontribute to other Regulatory documents may be provided RepresentsMW at meetings Drives document development meetings Articulatesdocument strategy and timelines Identifies the appropriate partiesfor a document content decision, and if a discussion is faltering,bring the discussion back on track with minimal fuss Followsdiscussions to their conclusion, synthesizes the message, andpresents clear accurate prose quickly Participates in processimprovement initiatives, working groups, etc. within MW andthroughout Global Development Drives processes and coordinatespriorities; solves problems; fosters collaboration to resolvesconflict May review the work of junior and outsourced MWs Mayreview CSR-related documents (Statistical Analysis Plans, TFLs) tohelp ensure appropriate content for inclusion Writes in plainlanguage style as appropriate (eg, for ICFs) Explains sophisticatedmedical/scientific concepts (such as medical procedures, clinicalstudy design, and drug mechanisms) to a lay or patient audience Maymentor junior staff Ensures adherence to applicable guidelines,templates and SOPs for all MW documents provided for therapeuticarea Remains aligned with internal training To be considered forthis role, you must have the following: Education Bachelor’s degree(advanced degree preferred) Experience Minimum of 3 years ofrelevant MW experience including working knowledge ofbiostatistics. Solid understanding of the clinical research processand regulations/guidelines Clinical document reading, writing, andediting experience Strong organizational, interpersonal andcommunication skills Solid understanding of MS WORD, Adobe Acrobat,PowerPoint, and electronic document management systems Ability tomanage multiple projects Familiarity with ICH GCP guidelines Doesthis sound like you? Apply now to take your first step towardsliving the Regeneron Way! We have an inclusive and diverse culturethat provides comprehensive benefits, which often include(depending on location) health and wellness programs, fitnesscenters, equity awards, annual bonuses, and paid time off foreligible employees at all levels! Regeneron is an equal opportunityemployer and all qualified applicants will receive considerationfor employment without regard to race, color, religion or belief(or lack thereof), sex, nationality, national or ethnic origin,civil status, age, citizenship status, membership of the Travelercommunity, sexual orientation, disability, genetic information,familial status, marital or registered civil partnership status,pregnancy or parental status, gender identity, gender reassignment,military or veteran status, or any other protected characteristicin accordance with applicable laws and regulations. The Companywill also provide reasonable accommodation to the knowndisabilities or chronic illnesses of an otherwise qualifiedapplicant for employment, unless the accommodation would imposeundue hardship on the operation of the Company’s business. Forroles in which the hired candidate will be working in the U.S., thesalary ranges provided are shown in accordance with U.S. law andapply to U.S.-based positions. For roles which will be based inJapan and/or Canada, the salary ranges are shown in accordance withthe applicable local law and currency. If you are outside the U.S,Japan or Canada, please speak with your recruiter about salariesand benefits in your location. Please note that certain backgroundchecks will form part of the recruitment process. Background checkswill be conducted in accordance with the law of the country wherethe position is based, including the type of background checksconducted. The purpose of carrying out such checks is for Regeneronto verify certain information regarding a candidate prior to thecommencement of employment such as identity, right to work,educational qualifications etc. Salary Range (annually) $126,700.00- $206,900.00