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HomeCompaniesHbap Fa Us1 Oraclecloud Com CX 1Associate Director, Medical Writing

Associate Director, Medical Writing

Hbap Fa Us1 Oraclecloud Com CX 1 · Waltham, MA, United States · Remote · Active · $175,000–$190,000 / week · Oracle Recruiting Cloud / Fusion HCM

Job facts

FieldValue
CompanyHbap Fa Us1 Oraclecloud Com CX 1
TitleAssociate Director, Medical Writing
Normalized title-
Department / teamResearch and Development
LocationWaltham, MA, United States
Work modelRemote / Remote
Employment typeFull Time
Salary$175,000–$190,000 / week
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-04-15 / 2026-05-31
Changed / last seen2026-05-31 / 2026-06-06

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Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through Oracle Recruiting Cloud / Fusion HCM.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Waltham.Open
Department jobsActive postings in Research and Development.Open
Work model jobsActive Remote postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyHbap Fa Us1 Oraclecloud Com CX 1
Sourcec9a1af55-d1aa-41d7-bb8e-0bf8dc082d85
ATS providerOracle Recruiting Cloud / Fusion HCM

Description

Description The Associate Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives. The Associate Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Associate Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives. Responsibilities Accountable for medical writing deliverables across one or more clinical programs, contributing to program-level plans and ensuring aligned timelines, quality, and resourcing. Independently author and lead the planning, review, comment resolution, and delivery of routine and complex clinical and regulatory documents. Lead or coordinate clinical content development for complex regulatory submissions, ensuring messaging alignment with regulatory strategy and development objectives. Serve as the primary medical writing lead on program teams, proactively identifying risks, anticipating cross-functional challenges, and driving issue resolution. Oversee outsourced writing support, setting expectations, managing review cycles, and ensuring inspection-ready quality. Contribute to the development and execution of Medical Writing departmental goals, including process improvements, inspection readiness initiatives, and adoption of new tools and technologies. Qualifications Advanced degree (PhD, PharmD, or equivalent) in a relevant discipline. 8+ years of relevant experience in medical writing, clinical research, or a related function; 2+ years of people-management or supervisory experience preferred. Experience supporting marketing authorization applications (NDA/BLA/MAA), IND submissions, and other major regulatory filings. Demonstrated ability to lead complex projects, plan and optimize resources (internal staff, vendors, and tools), and manage competing priorities. Strong ability to work independently, navigate ambiguity, and resolve complex, non-routine problems through pragmatic risk mitigation. Broad scientific understanding across multiple therapeutic areas; neuroscience experience preferred but not required. Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. The annual base salary for this position ranges from $175,000 - $190,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here #LI-MB1 Company Why join Team Alkermes? Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders. We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

Full job record

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Source IDc9a1af55-d1aa-41d7-bb8e-0bf8dc082d85
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Provideroracle_hcm
Provider Job Key13949
TitleAssociate Director, Medical Writing
Normalized Title
Statusactive
Activeyes
Location TextWaltham, MA, United States
DepartmentResearch and Development
Team
Employment Typefull_time
Workplace Typeremote
Remote Policyremote
CountryUnited States
RegionMA
CityWaltham
Salary RawDescription The Associate Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives. The Associate Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Associate Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives. Responsibilities Accountable for medical writing deliverables across one or more clinical programs, contributing to program-level plans and ensuring aligned timelines, quality, and resourcing. Independently author and lead the planning, review, comment resolution, and delivery of routine and complex clinical and regulatory documents. Lead or coordinate clinical content development for complex regulatory submissions, ensuring messaging alignment with regulatory strategy and development objectives. Serve as the primary medical writing lead on program teams, proactively identifying risks, anticipating cross-functional challenges, and driving issue resolution. Oversee outsourced writing support, setting expectations, managing review cycles, and ensuring inspection-ready quality. Contribute to the development and execution of Medical Writing departmental goals, including process improvements, inspection readiness initiatives, and adoption of new tools and technologies. Qualifications Advanced degree (PhD, PharmD, or equivalent) in a relevant discipline. 8+ years of relevant experience in medical writing, clinical research, or a related function; 2+ years of people-management or supervisory experience preferred. Experience supporting marketing authorization applications (NDA/BLA/MAA), IND submissions, and other major regulatory filings. Demonstrated ability to lead complex projects, plan and optimize resources (internal staff, vendors, and tools), and manage competing priorities. Strong ability to work independently, navigate ambiguity, and resolve complex, non-routine problems through pragmatic risk mitigation. Broad scientific understanding across multiple therapeutic areas; neuroscience experience preferred but not required. Excellent written and verbal communication skills, with proven ability to influence and collaborate across diverse teams. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. The annual base salary for this position ranges from $175,000 - $190,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here #LI-MB1 Company Why join Team Alkermes? Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders. We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Salary Min175,000
Salary Max190,000
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Salary Periodweek
Source URLhttps://hbap.fa.us1.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/13949
Apply URLhttps://hbap.fa.us1.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/13949
First Seen At2026-05-31 18:10:58Z
Last Seen At2026-06-06 11:11:22Z
Last Checked At2026-06-06 11:11:22Z
Last Changed At2026-05-31 18:10:58Z
Inactive At
Source Posted At2026-04-15 16:50:45Z
Source Updated At
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