{"id":3754076,"url":"https://alion.io/job/evolution-research-group-contract-medical-writer","title":"Contract Medical Writer","company":{"id":3876300,"name":"Evolution Research Group","domain":"ergclinical.com","url":"https://alion.io/company/evolution-research-group","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"A","score":95,"open_postings":7,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":71,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Communications","role_family":"Communications","seniority":"senior","employment_type":"contractor","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-04T16:21:57Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-10T06:19:06Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"The Contract Medical Writer assists in managing various aspects of medical writing activities, ensuring efficiency and compliance with regulations. This role encompasses responsibilities such as the research, creation, and editing of protocols, investigator brochures, clinical study reports, pre-IND briefing books, and IND submissions and updates for clinical trials/research (Phase I-IV). The Contract Medical Writer is also responsible for assisting with the development of corporate practices related to document handling, establishing guidance procedures, and ensuring adherence to corporate standards for clinical writing.\nESSENTIAL DUTIES AND RESPONSIBILITIESinclude the following.\nOther duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.\nCollaborate closely with internal and external teams, including Programming, Biostatistics, Regulatory Operations, Quality Operations and Project Management.\nDevelop and maintain document templates tailored for clinical trials.\nCreate and maintain writing guides specific to clinical trials.\nLead the development and implementation of study protocols and any protocol amendments.\nProvide comprehensive medical writing support throughout the lifecycle of clinical trial studies, including regulatory submissions and various required documents.Initial Investigational New Drug (IND) applications and amendments\nProtocols and protocol amendments\nInvestigator brochures and updates\nInterim and final clinical study reports\nIND annual reports\n\nEnsure all clinical study documentation complies with regulatory requirements.\nProactively coordinate and execute activities in accordance with Standard Operating Procedures (SOPs).\nManage project timelines and projections proactively.\nEnsure project quality through Quality Control of work.\nActively engage in sponsor/project team meetings.\nContribute to departmental and organizational meetings and initiatives.\nMaintain open communication with cross-functional groups throughout the project lifecycle and monitor project scope.\nCultivate and maintain key vendor relationships when applicable.\nPerform other miscellaneous duties as required.\nParticipate in corporate initiatives related to SOPs, standardization efforts, methods, techniques, and evaluation criteria for projects, programs, and personnel.\nQUALIFICATIONS\nTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.\nEDUCATION and/or EXPERIENCE\nBS/BA in a health-related or life science-related field. Master’s degree preferred. \nA minimum of 5 years of relevant experience in medical writing is required. \nDemonstrates extensive experience in the design, execution, and analysis of clinical studies. \nExperience in the Contract Research Organization (CRO) industry is preferred. \nSKILLS and/or ABILITIES\nExcellent organizational skills.\nStrong written and verbal communication skills.\nExceptional attention to detail.\nFamiliarity with industry principles of drug safety, US and international regulatory guidelines, drug development, biostatistics, pharmacology, and clinical trial methodology.\nKnowledge of clinical research including regulatory requirement GCP/ICH.\nStrong interpersonal skills.\nProficiency in Microsoft Office and computer skills.\nContractor shall be responsible for their own insurance.\nPHYSICAL DEMANDS\nThe physical demands described here are representative of those that must be met by a contractor to successfully perform the essential functions of this job.\nWhile performing the duties of this job, the Contractor regularly reaches with hands and arms. The contractor periodically is required to lift and/or carry up to 10 pounds. Occasionally, contractor stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.\nWORK ENVIRONMENT\nThe work environment characteristics described here are representative of those a contractor encounters while performing the essential functions of this job.\nMay work in an office or home office environment where the noise level is largely controlled by the contractor. Contractor may be subject to many interruptions; pressure due to meet deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.\nSAFETY REQUIREMENTS \nIn the interest of safety, Lotus Clinical Research contractors should practice safe use of cell phones and other mobile devices while driving on Company business and/or Company time, if applicable.","description_format":"text","description_chars":4595,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Home office"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)","Clinical Trial Sites & Recruitment"],"lifecycle":[{"event":"open","at":"2026-11-04T16:21:57Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":5,"expected_fill_days":71,"reasons":["conf:0","win:early"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/evolution-research-group-contract-medical-writer","json_url":"https://alion.io/job/evolution-research-group-contract-medical-writer.json","meta":{"generated_at":"2026-11-10T07:34:37Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":17666,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3876300},"rest":"https://alion.io/mcp/rest/get_company?id=3876300"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fevolution-research-group-contract-medical-writer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fevolution-research-group-contract-medical-writer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fevolution-research-group-contract-medical-writer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/evolution-research-group-contract-medical-writer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fevolution-research-group-contract-medical-writer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3754076}},{"tool":"search_jobs","arguments":{"company":"ergclinical.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3754076},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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