Oncology Medical Writer - Hybrid (Regulatory Submissions)
VORONOI, Inc.
Voronoi, Inc. is seeking an experienced Medical Writer with a strong background in oncology clinical trials. This hybrid role requires minimum 2 days onsite in Waltham, MA / Cambridge area, supporting regulatory and scientific documents for oncology programs. The candidate will write, edit, and manage sections of regulatory submissions, while mentoring junior writers and aligning with ICH-GCP guidelines and SOPs. #J-18808-Ljbffr VORONOI, Inc.
- [Voronoi, Inc.] Medical Writer (Hybrid Work) Medical Writer - Oncology Clinical Trials Location: minimum 2 days onsite... ...of preparing high-quality regulatory and scientific documents in support... ...NDAs, BLAs, and other regulatory submissions Collaborate with cross-...RegulatoryFor contractors
- Prometrika, Llc in Cambridge, MA is seeking a Senior Medical Writer to create and edit clinical and scientific reports crucial for regulatory submissions. The ideal candidate will have at least 6 years in medical writing, including 4 years specifically in regulatory scenarios...Regulatory
$117k - $143k
...Join our team in a dynamic hybrid role, offering flexibility to work remotely... ...is seeking an experienced Medical Writer to lead and coordinate the scientific and clinical regulatory writing aspects of documents that will support submission‑ready regulatory documents, clinical...RegulatoryRemote workFlexible hours$105k
...investigations. This position is hybrid or fully remote in the US... ...quality study documentation that is submission-ready for various regulatory agency and external distribution.... ...evidence for submission to peer-reviewed medical journals. Works with medical professionals...RegulatoryTemporary workFixed term contractWork at officeRemote workWorldwideFlexible hours$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug... ...7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge, Massachusetts...Regulatory- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The role is hybrid and full-time, requiring a proactive regulatory mindset and collaboration with...RegulatoryFull time
- ...is seeking a Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for both investigational and commercial... ...with cross-functional teams to ensure compliance and timely submissions. You will act as the primary CMC contact, influence regulatory...Regulatory
- ...Health is seeking a Principal / Senior Medical Writer with proven clinical document writing... ...experience. This remote role supports global regulatory deliverables and cross-functional... ...while delivering high-quality manuscripts and submissions on time. #J-18808-Ljbffr...RegulatoryRemote work
- ...Scientific Search seeks a Pharmaceutical Medical Writer to lead and coordinate scientific and regulatory writing for submission-ready documents, clinical studies, and publications. The role involves formatting using StartingPoint, managing development in Veeva and SharePoint...Regulatory
- ...Search has partnered with a late-stage biotech company to recruit a Contract Regulatory Medical Writer – QC Reviewer. This role leads the scientific and clinical regulatory writing for submission-ready documents, coordinating literature reviews and library oversight, and...RegulatoryContract work
$150k - $190k
...Senior Medical Writer The Senior Medical Writer will be responsible for authoring and managing clinical regulatory documents in support of the company's clinical development program... ...agency requests for information, IND/CTA submission documents, NDA/MAA clinical modules...RegulatoryFull time$134.75k - $162.89k
...operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re... .... RESPONSIBILITIES The Senior Medical Writer position requires writing and editing... ...from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive...RegulatoryFor contractorsWork experience placement$134.75k - $162.89k
...operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re... .... RESPONSIBILITIES The Senior Medical Writer position requires writing and editing... ...from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive...RegulatoryFor contractorsWork experience placement$172k - $232.8k
The Principal Medical Writ er (equivalent to Associate Director) represents medical... ...), and oversees the work of contract writers on the clinical program as well as other... ...sponsor/CRO setting. Experience with regulatory submissions (NDA/BLA/MAA) strongly preferred. CTA/...RegulatoryFull timeContract workTemporary workFor contractorsLocal areaFlexible hours$130k - $150k
...Office Job Description The Senior Medical Writer, Promotional Review, provides high-... ...based materials, strategy planning, NCCN Submissions and other medical affairs-based... ...document development, document types, regulatory requirements, and therapeutic area knowledge...RegulatoryTemporary workWork experience placementWork at officeLocal area- ...professionals specializing in medical writing, submission publishing, and clinical... ...team. The senior medical writer will partner cross-... ...Operations, Biostatistics, Regulatory, and Program Management in... ...higher in a relevant field Oncology, Infectious Disease, or Vaccine...RegulatoryLocal areaRemote work
- ...issues today and address the medical challenges of tomorrow. We... ...areas including immunology, oncology and neuroscience - and products... ...The Senior Manager, Regulatory Affairs US & Canada Strategy... ...preparation and review of regulatory submissions consistent within US and...RegulatoryLocal area
- ...seeking an experienced Clinical Trial Manager to lead oncology trials from First in Human through Phase III. This hybrid role will require regular presence at the... ...functional study teams, timelines, budgets, quality, and regulatory standards (ICH/GCP, SOPs). The role emphasizes...RegulatoryWork at office
$71k - $76.5k
...negotiable salary) Benefits: Hybrid working options that allow... ...flexible working hours, private medical and dental insurance, 401K... ...The Analyst and Medical Writer positions are ideal for recent... ...may have the chance to work on regulatory documents, lay summaries and...RegulatoryPermanent employmentFull timeTemporary workWork at officeImmediate startRemote workWork from homeWorldwideFlexible hours$71k - $76.5k
...negotiable salary). Benefits: Hybrid working options that allow... ...flexible working hours, private medical and dental insurance, 401K... ...Role The Analyst and Medical Writer positions are ideal for recent... ...reviews, grant applications, regulatory documents, and articles for websites...RegulatoryPermanent employmentFull timeWork at officeWork from homeFlexible hours$150k - $180k
...centralized infrastructure. Description of Role The Senior Medical Writer will author and manage clinical regulatory documents in support of the company’s clinical... ..., clinical study reports, and other regulatory submissions. Collaborate closely with Clinical Development,...RegulatoryFull time- ...supports the pharmaceutical, biotech, and medical device industries with a proven,... ...scientific approach to complex trial data and regulatory submission challenges. With a global footprint... ...minimal supervision, the Medical Writer will critically evaluate, analyze, and...RegulatoryRemote jobWorldwide
$70k - $73k
...in Boston is seeking enthusiastic individuals for Analyst and Medical Writer roles. You will engage in the analysis and presentation of clinical... ...$70,000 to $73,000 based on qualifications. Benefits include hybrid working options, generous holiday allowance, and private...- ...Biotherapeutics in Somerville is seeking an Associate Director of Quality Compliance to oversee regulatory submissions and lifecycle management of GTX products. This full-time hybrid role demands strong expertise in quality assurance, with responsibilities including...RegulatoryFull time
- ...reporting. You will create TLFs, LS, and data sets, ensuring regulatory compliance and efficiency through reusable macros. The role... ...ADaM knowledge, and collaboration with CROs to support FDA submissions. Hybrid in-office/remote work is offered in the Cambridge area. #J...RegulatoryWork at officeRemote work
- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses... ...teams to ensure timely and quality submissions to the FDA and other agencies. Ideal... ...regulatory requirements. Opportunities for hybrid work are available. #J-18808-Ljbffr...Regulatory
- ...Pharmaceutical, Inc. is seeking a Manager of Regulatory Affairs to lead regulatory support for... .... The role requires collaboration with Medical, Commercial, Legal, Compliance, and... .... The position focuses on IND/NDA submissions, regulatory publishing, and labeling management...Regulatory
- ...in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure... ...opportunity to contribute to innovative oncology therapies. #J-18808-Ljbffr Meet Life SciencesRegulatory
$177k - $278.08k
...advancing a rapidly growing oncology portfolio with... ...as a Director, Global Regulatory Lead Oncology where you... ...strategy and lead major submissions for high-impact... ...currently classified as "hybrid" following Takeda's Hybrid... ...to participate in medical, dental, vision insurance...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide- ...Analyst/Medical Writer InternshipOur Analyst/Medical Writer Internship is ideal for current... ...-effectiveness evidence to support HTA submissions to NICEThese meaningful and exciting projects... ...will be determined by business needs.Hybrid Working Policy: We believe that having...InternshipWork at officeWork from home1 day per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Oncology Medical Writer - Hybrid (Regulatory Submissions). Be the first to apply!
- medical purchasing Cambridge, MA
- night medical Cambridge, MA
- medical equipment Cambridge, MA
- medical marketing Cambridge, MA
- medical delivery Cambridge, MA
- remote medical claims processor Cambridge, MA
- medical communications Cambridge, MA
- advanced medical Cambridge, MA
- non certified medical Cambridge, MA
- medical account executive Cambridge, MA

