Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Medical Writing Lead - Regulatory Submissions

Scorpion Therapeutics

Scorpion Therapeutics in Burlington, MA, seeks an experienced medical writer to oversee the preparation and finalization of clinical and regulatory documents. The ideal candidate will have an advanced degree and over 5 years of experience in the biotechnology or pharmaceutical industry. The role involves ensuring scientific accuracy, collaboration with cross-functional teams, and development of writing processes. This position requires strong communication, organizational skills, and the ability to thrive in a fast-paced environment. #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Medical Writing Lead - Regulatory Submissions in Burlington, MA vacancy
  • Ipsen Biopharmaceuticals Inc. is looking for a Senior Medical Writer in Cambridge, US. This role involves producing high-quality...  ...documentation and managing the preparation of regulatory documents for submissions to global health authorities. The ideal applicant will... 
    Senior
    Medical
    Regulatory
    Flexible hours

    Ipsen Group

    Cambridge, MA
    1 day ago
  • $150k - $200k

    A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development stages...  ...7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from... 
    Medical
    Regulatory

    Orion Corporation

    Cambridge, MA
    2 days ago
  • 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... 
    Senior
    Medical
    Regulatory

    Prometrika, Llc

    Cambridge, MA
    2 days ago
  • Creative Solutions Services, LLC in Cambridge, Massachusetts is seeking a Regulatory Submissions Lead to oversee publishing activities for IND, NDA, ANDA, and more. The ideal candidate will manage submission processes, ensure quality control, and mentor team members. A... 
    Senior
    Regulatory

    Creative Solutions Services, LLC

    Cambridge, MA
    4 days ago
  • $229.8k - $381.7k

     ...limited to: Provide medical leadership across...  ...centric development. Lead clinical development...  ...Operations, Safety, Biostats, Regulatory, Quality, Medical...  ...Support regulatory submissions and interactions (briefing...  ...~ Strong medical writing and document review skills... 
    Senior
    Medical
    Regulatory
    Local area
    Immediate start
    Shift work

    Merck Group

    Billerica, MA
    22 hours ago
  • $248.5k

     ...Program Leader (CPL) / Senior Clinical Program Leader...  ...Responsibilities Provides strategic medical guidance for the...  ...registration trials. Leads Biomedical Research...  ..., investigators, and regulatory authorities in the field...  ...clinical studies. Writes and reviews abstracts/manuscripts... 
    Senior
    Medical
    Regulatory
    Remote work
    Worldwide

    Dormont Manufacturing Co

    Cambridge, MA
    3 days ago
  • $110.39k - $151.81k

    ## Software Medical WriterApplylocations: US...  ...and Twitter (X).**Senior Software Medical Writer...  ...Medical Writer to lead the creation and...  ..., Quality, Regulatory Affairs, and Product...  ...inspections, and regulatory submissions with audit‐ready...  ..., or technical writing within regulated... 
    Senior
    Medical
    Regulatory
    Permanent employment
    Work at office
    Day shift

    Analog Devices

    Wilmington, MA
    2 days ago
  • Analog Devices, Inc. is looking for a Senior Software Medical Writer to lead the development of software lifecycle documentation for medical...  ...ideal candidate has significant experience in medical writing, strong regulatory knowledge, and excellent communication skills. The... 
    Senior
    Medical
    Regulatory
    Full time

    Analog Devices

    Wilmington, MA
    4 days ago
  • $17 - $19 per hour

     ...POSITION SUMMARY: The Shift Lead is responsible for executing...  ...policies, procedures, and regulatory requirements. KEY DUTIES/RESPONSIBILITIES...  .... Fundamental reading, writing, math and computer/POS skills...  ...$19/hour Benefits: Medical, Dental, Vision, & 401k for... 
    Medical
    Regulatory
    Local area
    Shift work
    Weekend work

    Qdoba

    Burlington, MA
    4 days ago
  • $212k - $333.19k

    Senior Director, Global Program Lead - Neuroscience Cambridge, MA Are you looking for...  ...to simultaneously driving regulatory approval as well as launch...  ...in the context of unmet medical need, competitive landscape...  ...large-scale Phase III/submission projects and global launch... 
    Senior
    Medical
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Work at office
    Local area
    Remote work

    Initial Therapeutics, Inc.

    Cambridge, MA
    4 days ago
  • A leading pharmaceutical company is looking for a Medical Writing Operations Manager to ensure high-quality, submission-ready documents. The role includes reviewing and formatting documents...  ...field and at least 4 years of regulatory document experience in biotech or pharma... 
    Senior
    Medical
    Regulatory
    Contract work

    Planet Pharma

    Cambridge, MA
    2 days ago
  • $150k - $200k

    Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion Pharma...  ...across all phases of drug development and global regulatory submissions, ensuring quality and compliance through leadership and... 
    Medical
    Regulatory
    Worldwide

    Orion Corporation

    Cambridge, MA
    2 days ago
  • $263k - $328k

     ...worldwide. Could you be our next Senior Director Search & Evaluation Late TA Lead, Immunology? The job is in our...  ...align with TA strategy and unmet medical needs. ​ Co-lead internal...  ...stage assets, coordinating clinical, regulatory, commercial, and market access... 
    Senior
    Medical
    Regulatory
    Work at office
    Worldwide
    3 days per week

    CSL Behring

    Waltham, MA
    -97
  • $229.8k - $381.7k

     .... Your Role You will provide medical leadership across rheumatology...  ...‑centric focus. You will lead clinical development planning...  ...Ops, Safety, Biostatistics, Regulatory, Quality, Medical Affairs, and...  ...for extended periods (reading/writing/reviewing documents, virtual... 
    Senior
    Medical
    Regulatory
    Flexible hours

    Myana

    Billerica, MA
    3 days ago
  • $143k - $169k

     ...Senior Statistical Programmer The Senior Statistical...  ...limited to, datasets in submission ready standard format (ADaM...  ...Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure...  ...Submission content. Leads the production and validation... 
    Senior
    Medical
    Regulatory
    Contract work
    3 days per week

    CSL

    Waltham, MA
    2 days ago
  • $134.4k - $219.2k

     ...organization is seeking a Senior Manager, Aggregate...  ..., distribution and submission of periodic and ad-hoc...  ...) Deliverables Leads Aggregate Report planning...  ...Development, Regulatory Affairs, Statistics,...  ...inspections (PV and GCP) Medical writing experience with... 
    Senior
    Medical
    Regulatory
    Contract work
    Local area
    Worldwide

    Regeneron Pharmaceuticals

    Cambridge, MA
    2 days ago
  • $134.75k - $162.89k

     ...management, biostatistics, medical writing, and pharmacovigilance. We...  .... RESPONSIBILITIES The Senior Medical Writer position requires...  ...statistical analyses for submission to regulatory agencies or sponsor use,...  ...meetings Assist with leading Medical Writing departmental... 
    Senior
    Medical
    Regulatory
    For contractors
    Work experience placement

    Prometrika, Llc

    Cambridge, MA
    2 days ago
  • $111k - $185k

    Company Lantheus is a leading radiopharmaceutical company...  ...Role Document Control Senior Specialist responsible...  ...and applicable global regulatory requirements. Serves...  ...pharmaceutical, medical device or biological industries...  ...Proficient technical writing skills. Expertise in... 
    Senior
    Medical
    Regulatory
    Local area
    3 days per week

    Lantheus

    Bedford, MA
    22 hours ago
  • Cookie Notice**Title:**Senior Clinical Project...  ...of high unmet medical need through research...  ...*** Set-up and lead the study Cross Functional...  ...Experts, Global Regulatory Affairs and Global...  ...to support the submission and approval of...  ...CSR with Medical Writing.* Ensure the finalization... 
    Senior
    Medical
    Regulatory
    Local area

    Ipsen Group

    Cambridge, MA
    2 days ago
  • Ipsen Biopharmaceuticals Inc. is seeking a Senior Medical Writer to produce high-quality clinical...  ...documentation. You will manage complex regulatory documents, mentor junior writers, and...  ...over 5 years of experience in clinical writing and a background in life sciences. The... 
    Senior
    Medical
    Regulatory

    Ipsen Biopharmaceuticals Inc.

    Cambridge, MA
    22 hours ago
  • $162k - $212k

     ...visit Position Purpose The Senior Manager, Corporate...  ...will be responsible for leading content strategy, execution...  ...enterprise-wide and manage the Medical, Legal, Compliance, and Regulatory approval processes...  ...digital channels Strong writing and storytelling skills,... 
    Senior
    Medical
    Regulatory
    Temporary work

    Stoke Therapeutics

    Bedford, MA
    2 days ago
  •  ...experienced Oncology Clinical Pharmacologist to lead strategic medical guidance for the development of new...  ...trial conduct and compliance with regulatory requirements. The ideal candidate will...  ...oncology, supported by strong medical writing and team leadership skills. The... 
    Senior
    Medical
    Regulatory

    Scorpion Therapeutics

    Cambridge, MA
    2 days ago
  • $112.5k - $165k

    ## Senior Medical WriterApplylocations: Cambridge (US)time type:...  ...the writer will develop regulatory documents for submission to global health authorities...  ...*** **Main Medical Writing responsibilities:** + Manage...  ...brochures, clinical modules + Lead Writing/Editing complex... 
    Senior
    Medical
    Regulatory
    Temporary work
    Work at office
    Local area
    Flexible hours

    Ipsen Group

    Cambridge, MA
    22 hours ago
  • $112.5k - $165k

    Title: Senior Medical Writer Ipsen Biopharmaceuticals Inc...  ...Responsibilities Main Medical Writing Responsibilities...  ...of complex regulatory documents such as protocols...  ...and clinical modules. Lead writing and editing...  ...timelines, reviews and submissions. Preferred Experience... 
    Senior
    Medical
    Regulatory
    Temporary work
    Work at office
    Flexible hours

    Ipsen Biopharmaceuticals Inc.

    Cambridge, MA
    4 days ago
  • Prometrika LLC in Cambridge, Massachusetts, is seeking a Manager, Medical Writing, to oversee the development of clinical regulatory documents essential for global drug development. You will manage projects and guide junior writers, ensuring compliance with regulatory... 
    Senior
    Medical
    Regulatory

    Prometrika

    Cambridge, MA
    22 hours ago
  • $212k - $333.19k

    Senior Director, Global Program Lead-Neuroscience Cambridge, MA office Overview The Global Program Leader (...  ...the marketplace. The GPL balances regulatory approval, launch, and global patient...  ...and other factors. Benefits include medical, dental, vision, 401(k) with... 
    Senior
    Medical
    Regulatory
    Temporary work
    Work at office
    Local area

    Takeda Pharmaceuticals International GmbH

    Cambridge, MA
    2 days ago
  • $173.39k - $210.11k

    Senior Manager, Global Clinical Science Position Summary...  ...as Clinical Trial Lead for one or more trials...  ...to CSR and regulatory documents (e.g., IB, DSUR...  ...contribute to regulatory submission. Degree Requirements...  ...identification. Intermediate medical writing skills and medical... 
    Senior
    Medical
    Regulatory
    Full time
    Temporary work
    Flexible hours
    Shift work

    Myana

    Cambridge, MA
    2 days ago
  • $103.9k - $155.9k

    Merck Group is seeking a regulatory affairs professional for their Billerica, MA location. This role is crucial for leading regulatory submissions and ensuring compliance across regional teams. Successful candidates will have experience interacting with the FDA, a demonstrated... 
    Regulatory

    Merck Group

    Billerica, MA
    1 day ago
  • $278k - $382k

     ...Global SMA/ALS Medical Lead The Global SMA/ALS Medical Lead will be a strategic partner providing medical leadership, people management...  ...and governance meetings requiring medical inputs (e.g. PDC, Regulatory forums, R&D, safety). Work in close partnership with PDC,... 
    Senior
    Medical
    Regulatory
    Temporary work
    Local area

    Biogen

    Cambridge, MA
    4 days ago
  • $96.01k - $116.34k

     ...skilled and motivated Senior Associate...  ...LC/MS platforms. Lead phase‑appropriate...  ...Strong technical writing skills for reports, protocols, and regulatory documentation. Familiarity...  ...data and submissions. If you come across...  ...Health Coverage: Medical, pharmacy, dental... 
    Senior
    Medical
    Regulatory
    Hourly pay
    Full time
    Temporary work
    Part time
    Summer work
    Live in
    Remote work
    Flexible hours
    Shift work

    Bristol Myers Squibb

    Cambridge, MA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Medical Writing Lead - Regulatory Submissions. Be the first to apply!