Senior Medical Writing Lead Regulatory Documents
Vertex Pharmaceuticals
A biopharmaceutical company in Boston, MA is seeking a Medical Writing Science Manager responsible for preparing clinical and regulatory documents. The role demands superior communication skills, experience in writing clinical documents, and a Ph.D. The candidate will lead document authorship and analyze clinical data. This position offers a hybrid work model, competitive salary, and extensive benefits including paid time off and educational assistance. #J-18808-Ljbffr
- RBW Consulting LLP is seeking an experienced Head of Medical Writing to lead the development and delivery of high-quality clinical and regulatory documents. This role involves providing scientific leadership, partnering with various departments to ensure accurate, compliant...DocumentSeniorMedicalRegulatory
$130k - $150k
...Medicines, Inc. is seeking a talented Medical Writer to oversee documents for clinical development programs.... ...requires at least 4 years of medical writing experience in a Sponsor or CRO... ...discipline. Responsibilities include leading the preparation of clinical trial documents...DocumentSeniorMedicalRegulatoryRemote jobFlexible hours$113k - $142.43k
...A leading biopharmaceutical company is seeking a Senior Regulatory Medical Writer to lead the creation and management of clinical regulatory documents. This role primarily involves collaboration across teams... ...extensive experience in writing regulated documents and a strong...DocumentSeniorMedicalRegulatoryRemote work- ...Global Regulatory Strategy Lead Act as responsible for establishment of Global Regulatory strategy and pathway for one/several... ...strategy to focus on agreed major markets) and for writing the Regulatory Strategy Document. Define the strategy for major Health...DocumentSeniorRegulatory
- ...A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should...DocumentSeniorMedicalRegulatory
- ...A leading biotechnology company is seeking a Medical Writing Science Senior Manager to author complex clinical regulatory documents. The role demands exceptional writing and project management skills, alongside a Ph.D. and significant experience in clinical writing. This...DocumentSeniorMedicalRegulatoryRemote work
- ...solutions provider is seeking a Sr Medical Writer Publications for a... .... In this role, you will lead medical writing deliverables, managing... ...and ensuring compliance with regulatory standards. Key... ...include completing scientific documents like journal manuscripts, conducting...DocumentSeniorMedicalRegulatoryRemote workFlexible hours
$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development stages. The successful candidate... ...of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to...DocumentMedicalRegulatory- ...Senior Workday Integration Lead The Talent / HRIS Platforms team is seeking a... ...comprehensive technical documentation, including data maps, architectural... ...geographies and local regulatory requirements. ~... ...Full Health Benefits (Medical, Dental, Vision, HSA/FSA)...DocumentSeniorMedicalRegulatoryTemporary workLocal areaWorldwideFlexible hours
- 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...DocumentSeniorMedicalRegulatory
- ...of a clinical service, medical/surgical practice, and... ...or management office. Leads and performs... ...personnel records and regulatory reporting. Processes administrative... ..., and reappointment documents. Assists with... ...effectively both orally and in writing, and provide empathy...DocumentMedicalRegulatoryWork at office
- 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, supporting... ...field and at least 4 years of regulatory document experience in biotech...DocumentSeniorMedicalRegulatoryContract work
$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid)... ...overseeing the creation and delivery of clinical documents across all phases of drug development and global regulatory submissions, ensuring quality and compliance...DocumentMedicalRegulatoryWorldwide- ...Central Reading Centers, Labs, Medical Coders). uthor key documents, including Data... ...ready manner. Support Lead Clinical Programmers in developing... ..., Programming, and Regulatory teams. Review study... ...skills, with experience writing Data Management Plans, Data...DocumentSeniorMedicalRegulatory
- ...Senior Director of Global Patient Safety & Risk Management... ...clinical development, regulatory, medical affairs, and... ...Responsibilities Lead active monitoring and... ...all other regulatory documents. Serve as the safety... ...experience including writing of initial and follow-...DocumentSeniorMedicalRegulatoryWorldwideFlexible hours
$47.5k - $66.5k
...Medical Assistant Team Lead The Medical Assistant (MA) Team Lead supports the efficient... ...safety standards to meet regulatory requirements including,... ...health screenings, document care, coordinate patient care... ...effectively, both verbally and in writing, with patients, families,...DocumentMedicalRegulatoryFull timeWork experience placementFlexible hoursShift work$113k - $142.43k
...three decades discovering medical breakthroughs that... ...marketed medicines and a leading pipeline in neurology,... ...expand your career!Senior Regulatory Medical WriterThe Senior... ...teams to lead, write, and manage completion... ...of clinical regulatory documents. This role is an individual...DocumentSeniorMedicalRegulatoryWork at officeRemote work$250k - $295k
...about the potential of our lead program, RAP-219. Our first... ...! Your Impact: This Medical Director role offers the opportunity... ...to the development of regulatory documents in support of regulatory submissions... ...both verbally and in writing Demonstrated ability to...DocumentSeniorMedicalRegulatoryFull timeLocal areaImmediate start$275k - $300k
...centric model can lead to improved success... ...is seeking a Senior Director, Toxicology... ...contributions to global regulatory submissions.... ...global regulatory documents, including pre-IND... ...communication and scientific writing skills as applied... ...company-sponsored medical, dental, vision,...DocumentSeniorMedicalRegulatoryFull time$286.9k
...Senior Principal Scientist (Senior Medical Director) Translational Medicine, Immunology... ...with scientific, regulatory, statistical, and... ...Therapeutic Area Lead in Translational Medicine... ...registration documents and presentations.... ...Strong interpersonal, writing and presentation...DocumentSeniorMedicalRegulatoryWorldwide- ...and are exploring regulatory pathways for Europe... .... We are seeking a Senior Clinical Trial Manager... ...members to lead the clinical project... ...Contribute to the writing and/or review of clinical documents such as Protocols,... ...documents. Liaise with medical monitor and cross functional...DocumentSeniorMedicalRegulatoryContract workLocal area
- ...Senior Pharmaceutical Copywriter If you are looking... ...in deciphering medical and scientific literature... ...guides Use core claims documents to leverage client-... ...Pivot from DTC to HCP writing whenever needed Stay... ...practices and regulatory requirements that affect...DocumentSeniorMedicalRegulatory
- ...to turn cutting-edge medical research into usable,... ...capable and compliant with Regulatory requirements, and are... ...optimal providers. Lead and collaborate with... ...and tests (including writing and executing protocols... ...instructions, and other documents that require quality...DocumentSeniorMedicalRegulatoryContract workWork at office
- ...Medical Director/Senior Medical Director Boston (USA) Full-time Permanent... ...clinical trials. You will lead all clinical aspects of clinical... ...trial and program level regulatory documents such as protocol &... ...IV trials. ~ Experience writing protocol amendments, informed...DocumentSeniorMedicalRegulatoryOdd jobPermanent employmentFull timeRemote workRelocation
- ...Senior Clinical Project Manager Ipsen is... ...areas of high unmet medical need through... ...Set-up and lead the study Cross Functional... ...Medical Experts, Global Regulatory Affairs and Global... ...of the study document and plans, defining... ...CSR with Medical Writing. Ensure the finalization...DocumentSeniorMedicalRegulatoryLocal area
$150.5k - $245.5k
...The Senior Clinical Study Lead (CSL) is expected to operate with high... ...of study specific documentation including but not limited... ...study report writing and review Facilitates... ...Knowledge of ICH/GCP and regulatory guidelines/... ...programs (including medical, dental, vision, life...DocumentSeniorMedicalRegulatoryLocal area- ...familiar with drug development and regulatory requirements and will deploy... .... Collaborates with medical writing to author clinically... ...amendments Authors and/or reviews documents related to trials, such as... ...with minimal support Leads planning and prepares information...DocumentSeniorMedicalRegulatoryPermanent employmentContract workRemote work
$145k - $215k
...building an industry-leading pipeline of oral small... ..., organizational, and regulatory standards. Conduct ongoing... ...safety. Perform medical data monitoring, including... ...of study-related documents (e.g., protocols, amendments... ...and excellent medical writing skills. Equal...DocumentSeniorMedicalRegulatory$168k - $188k
...Set up and oversee clinical trial‑related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/... ...areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance) Other Essentials And Key...DocumentSeniorMedicalRegulatoryContract workLocal areaRemote work$232k - $348k
...Description The Regulatory Strategy Senior Director is a regulatory... ...: Leads the development of regulatory... ...Regulatory Strategy Documents including for regulatory... ...presentations and in writing regulatory strategy plans... ...aspirations. From medical, dental and vision...DocumentSeniorMedicalRegulatorySummer workLocal areaRemote workFlexible hours2 days per week3 days per week
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