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Senior Medical Writer

08c84dac E79e 44fa 9484 4cd440390eb1 19000101 000001 · Cambridge, MA, US, Cambridge, MA · Active · $134,752–$162,888 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
Company08c84dac E79e 44fa 9484 4cd440390eb1 19000101 000001
TitleSenior Medical Writer
Normalized title-
Department / team-
LocationCambridge, MA, United States
Work model-
Employment typeFull Time
Salary$134,752–$162,888 / year
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-03-13 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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Company jobsActive postings from 08c84dac E79e 44fa 9484 4cd440390eb1 19000101 000001.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through ADP Workforce Now Recruiting.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Cambridge.Open
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Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

Company08c84dac E79e 44fa 9484 4cd440390eb1 19000101 000001
Source3bc242f4-b3c0-49b7-ad56-c269f0dfc936
ATS providerADP Workforce Now Recruiting

Description

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. RESPONSIBILITIES The Senior Medical Writer position requires writing and editing of clinical and scientific reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Senior Medical Writer will also assist with and contribute to departmental leadership initiatives, training initiatives, business development efforts and organizational thought leadership. The Senior Medical Writer will: Mentor and train junior medical writers and/or external contractors Work with the sponsor’s and/or PROMETRIKA’s medical personnel and statisticians to develop/write clinical development plans, clinical study protocols, clinical study reports, and other documents, as appropriate Create template/shell for integrated clinical study report based on ICH guidelines and sponsor’s standards and in accordance with the study protocol Hold review meetings to discuss edits provided by the PROMETRIKA team and/or the sponsor, as needed Write journal articles, abstracts, and posters in cooperation with responsible statisticians and/or the sponsor Develop/write clinical sections of INDs, NDAs, and other submission documents Write investigator brochures Prepare annual reports and briefing documents for regulatory submission Manage consistency of style, format, and content for all IND and NDA documents within a given project Review and provide feedback on medical writing SOPs Attend project team and client meetings as required Assist with contributing materials and presenting at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization Assist with contributing to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate Support in collaborating with Client Relations to participate in Medical Writing at bid defense meetings Assist with leading Medical Writing departmental initiatives aligned with organizational strategic goals Uphold, demonstrate and teach junior team members PROMETRIKA’s Core Competencies Assist with developing internal training materials and deliver training as in support of PROMETRIKA Technical Training Committee initiatives Perform other duties as assigned EDUCATION Bachelor’s degree in a scientific discipline is required Graduate degree is preferred EXPERIENCE Minimum of 6 years of experience in medical writing with a minimum 4 years regulatory writing in biotechnology/pharmaceutical industry SKILLS Knowledge of ICH recommended content of Investigator Brochure, Clinical Study Report, IND, IND updates and NDA along with previous involvement in writing at least one NDA or BLA is required. Knowledge of electronic document platforms is desired Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred Physical Requirements Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time. The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.

Full job record

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Source ID3bc242f4-b3c0-49b7-ad56-c269f0dfc936
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Provider Job Key505698
TitleSenior Medical Writer
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First Seen At2026-05-31 18:27:52Z
Last Seen At2026-06-06 11:43:19Z
Last Checked At2026-06-06 11:43:19Z
Last Changed At2026-06-06 11:43:19Z
Inactive At—
Source Posted At2026-03-13 20:14:00Z
Source Updated At—
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    "requisitionDescription": "<div><p style=\"margin: 0in; font-size: 16px; font-family: Cambria, serif; text-align: justify;\" data-pasted=\"true\"><strong><span style=\"font-family: 'times new roman',serif;\">PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We&rsquo;re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.</span></strong></p><div><strong style='--tw-shadow: 0 0 #0000; --tw-ring-inset: var(--tw-empty,/*!*/ /*!*/); --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(59,130,246,.5); --tw-ring-offset-shadow: 0 0 #0000; --tw-ring-shadow: 0 0 #0000; box-sizing: border-box; font-weight: 700; color: rgb(38, 35, 33); font-family: \"Times New Roman\", serif; font-size: 16px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: justify; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;' id=\"isPasted\"><span style='font-size: 16px; font-family: \"times new roman\", serif;'><br></span></strong><p id=\"isPasted\"><span style='font-size: 16px; font-family: \"times new roman\", serif;'><strong>RESPONSIBILITIES</strong></span></p><p><span style='font-size: 16px; font-family: \"times new roman\", serif;'>The Senior Medical Writer position requires writing and editing of clinical and scientific reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Senior Medical Writer will also assist with and contribute to departmental leadership initiatives, training initiatives, business development efforts and organizational thought leadership. The Senior Medical Writer will:</span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><ul><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Mentor and train junior medical writers and/or external contractors</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Work with the sponsor&rsquo;s and/or PROMETRIKA&rsquo;s medical personnel and statisticians to develop/write clinical development plans, clinical study protocols, clinical study reports, and other documents, as appropriate</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Create template/shell for integrated clinical study report based on ICH guidelines and sponsor&rsquo;s standards and in accordance with the study protocol</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Hold review meetings to discuss edits provided by the PROMETRIKA team and/or the sponsor, as needed</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Write journal articles, abstracts, and posters in cooperation with responsible statisticians and/or the sponsor</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Develop/write clinical sections of INDs, NDAs, and other submission documents</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Write investigator brochures</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Prepare annual reports and briefing documents for regulatory submission</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Manage consistency of style, format, and content for all IND and NDA documents within a given project</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Review and provide feedback on medical writing SOPs</span></li><li style='margin-top: 0in; margin-right: 0in; margin-bottom: 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'><span style=\"line-height: 106%;\">Attend project team and client meetings as required</span></li><li style=\"line-height: 2;\">Assist with contributing materials and presenting at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization</li><li style=\"line-height: 2;\">Assist with contributing to PROMETRIKA&rsquo;s newsletters, thought leadership blogs, and other publications as appropriate</li><li style=\"line-height: 2;\">Support in collaborating with Client Relations to participate in Medical Writing at bid defense meetings</li><li style=\"line-height: 2;\">Assist with leading Medical Writing departmental initiatives aligned with organizational strategic goals</li><li style=\"line-height: 2;\">Uphold, demonstrate and teach junior team members PROMETRIKA&rsquo;s Core Competencies&nbsp;</li><li style=\"line-height: 2;\">Assist with developing internal training materials and deliver training as in support of PROMETRIKA Technical Training Committee initiatives</li><li style=\"line-height: 2;\"><span style=\"line-height: 106%;\">Perform other duties as assigned</span></li></ul></div><p style='margin:0in;text-indent:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><span style='font-size: 16px; font-family: \"times new roman\", serif;'><strong>&nbsp;</strong></span></p><p style='margin:0in;text-indent:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><span style='font-size: 16px; font-family: \"times new roman\", serif;'><strong>&nbsp;</strong><strong>EDUCATION</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;margin-left: 0in;\"><li style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'>Bachelor&rsquo;s degree in a scientific discipline is required</li><li style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'>Graduate degree is preferred</li></ul></div><p style='margin:0in;text-indent:0in;font-size:16px;font-family:\"Times New Roman\",serif;margin-left:.5in;'><span style='font-size: 16px; font-family: \"times new roman\", serif;'><br></span></p><p style='margin:0in;text-indent:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><span style='font-size: 16px; font-family: \"times new roman\", serif;'><strong>&nbsp;</strong><strong>EXPERIENCE</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom: 0in; margin-left: 0in;\"><li style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'>Minimum of 6 years of experience in medical writing with a minimum 4 years regulatory writing in biotechnology/pharmaceutical industry</li></ul><p><br></p><p style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'><strong>SKILLS</strong></p></div><div style='margin-top:0in;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;font-size:16px;font-family:\"Times New Roman\",serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'>Knowledge of ICH recommended content of Investigator Brochure, Clinical Study Report, IND, IND updates and NDA along with previous involvement in writing at least one NDA or BLA is required.&nbsp;</li><li style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'>Knowledge of electronic document platforms is desired</li><li style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif; line-height: 2;'>Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred</li></ul><p style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'><br></p><p style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'><strong><span style=\"text-transform:uppercase;\">Physical Requirements</span></strong></p><p style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'>Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.</p><p style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'><br></p><p style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'><br></p><p style='margin: 0in 0in 6pt; font-size: 16px; font-family: \"times new roman\", serif;'><em data-pasted=\"true\"><span style='font-size: 16px; font-family: \"times new roman\", serif;'>The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate&rsquo;s work experience, education/training background and parity with current employees in the same or similar positions.</span></em></p></div><p style=\"margin-left:.5in;\"><br></p></div></div>\n",
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          },
          "indicatorValue": false
        }
      ]
    },
    "requisitionTitle": "Senior Medical Writer ",
    "clientRequisitionID": "1097",
    "organizationalUnits": [],
    "postingInstructions": [],
    "additionalProperties": {},
    "requisitionLocations": [
      {
        "address": {
          "cityName": "Cambridge",
          "postalCode": "02140",
          "countrySubdivisionLevel1": {
            "codeValue": "MA"
          }
        },
        "nameCode": {
          "shortName": " Cambridge, MA, US"
        },
        "aliasNames": []
      }
    ],
    "screeningRequirements": [],
    "sponsoredVisaTypeCodes": []
  },
  "detail_meta": {
    "url": "https://workforcenow.adp.com/mascsr/default/careercenter/public/events/staffing/v1/job-requisitions/505698?cid=08c84dac-e79e-44fa-9484-4cd440390eb1&ccId=19000101_000001&lang=en_US&locale=en_US",
    "http_status": 200,
    "content_type": "application/json;charset=UTF-8",
    "response_bytes": 15807
  },
  "detail_errors": []
}
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