Cardiology Medical Writing Director — Regulatory Submissions
$285k - $345kPiper Companies
A biotechnology firm in Palo Alto is seeking an Executive Director of Medical Writing to oversee the Cardiology medical writing activities, ensuring high-quality documents that align with clinical and regulatory objectives. The ideal candidate will have over 12 years of experience in regulatory medical writing within biotechnology or pharmaceuticals, demonstrating leadership and excellent communication skills. A comprehensive benefits package, including medical and dental insurance, is offered alongside a competitive salary range of $285,000 to $345,000. #J-18808-Ljbffr Piper Companies
- ...****@*****.*** of Regulatory AffairsThe Director of Regulatory Affairs is... ...Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to... ...delivering global regulatory strategies and submissions.Demonstrated success in leading...SuggestedWork experience placement
$302.01k - $390.83k
...OVERVIEW:The Executive Director, Head of Precision Medicine Regulatory is responsible for defining... ...relative to premarket submission, IVD partnering, FDA and... ...strong communication and writing skills, project... ...include company-sponsored medical, dental, vision, and life...SuggestedFull timeFor contractorsWork at officeLocal areaFlexible hours$194k - $199k
Summit Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This... ...focuses on managing CMC regulatory aspects and preparing submissions. The salary range for this position is approximately $194,...SuggestedWork at office- ...Iovance Biotherapeutics, Inc. is seeking a Director of Regulatory CMC to lead one or more drug... ...programs with emphasis on global strategy, submissions, and Health Authority interactions.... ...for oncology products and expert writing of regulatory documents. The candidate...Suggested
$186k - $233k
...pathway.The Opportunity:The Associate Director of Regulatory Affairs will provide regulatory... ...prepare, and coordinate regulatory submissions, ensuring high quality and timeline... ...Research, Clinical Operations, Regulatory, Medical Writing, and other functions to ensure...SuggestedFull timeWork experience placementLocal area$295k - $339k
...clinical science drug developer to serve as Medical Director in support of Revolution Medicines’... ...of clinical data supporting regulatory submissions (NDA, BLA, MAA). This role is uniquely... ...Biostatistics, Data Management, and Medical Writing to ensure clinical datasets,...Full timeLocal area$170k - $220k
...CAssociate Director/ Director, Regulatory Affairs About the Company Dren Bio is... ...programs, as well as oversee the writing, preparation and finalization of regulatory submissions and communications with... ..., gender identity, medical condition, pregnancy, marital...Local area- Summit Therapeutics in Palo Alto, CA, seeks an Associate Director for Regulatory Affairs, focusing on Chemistry, Manufacturing, and Controls... ...input, document preparation and management of regulatory submissions. Applicants with a Bachelor's degree in Chemistry or related...
$186k - $233k
...The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership... ...prepare, and coordinate regulatory submissions, ensuring high quality and timeline... ..., Clinical Operations, Regulatory, Medical Writing, and other functions to ensure...Full timeWork experience placementLocal area- ...We sit at the intersection of clinical cardiology, hardware, software, and data, building... ...the day-to-day operational, clinical, and regulatory functions of our Independent Diagnostic... ...ensure all diagnostic tests are ordered in writing by the treating physician and that...For contractorsWork at officeLocal areaRemote workShift work
$114k - $228k
...and products in diagnostics, medical devices, nutritionals and branded... ...and peripheral stents.This Regulatory Affairs Manager position is... ...approval clinical strategy and submission activitiesAnticipate... ...communicate verbally and in writing, prepare, and negotiate both...Shift work$298k - $350.6k
...Senior Medical Director, Oncology Redwood City, California, United... ...Develop and participate in the writing and review of protocols,... ...reports and other clinical and regulatory documents Provide... ...writing for global regulatory submissions Work closely and collaboratively...Full time$250k - $300k
...Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full-Time... ...Position Summary: The Senior Director, Regulatory Affairs is Orca... ...incumbent will assist the Chief Medical Officer to develop and... ...preparation for future major submissions.Develop and recommend regulatory...Full timeLocal areaImmediate startRemote work- ...research studies to support regulatory approvals and key strategic evidence... ...States (IDE for 510k or PMA submissions) and utilizing resources to... ...scientific literature and write clinical summaries to assist... ...implementing, supporting and managing medical device trials Significant...Interim roleLocal areaRemote workWorldwideFlexible hoursShift work
$229.3k - $269.8k
...Associate Medical Director, Oncology Redwood City, California, United... ...and participate in the writing and review of protocols, investigator... ...and other clinical and regulatory documents Establish and... ...for global regulatory submissions Work closely and collaboratively...Full time- ...not limited to Hepatology, Cardiology, Endocrinology, Nephrology,... ...recruitment, retention and regulatory support to ensure GCP compliance... .... Coordinate new protocol submissions, renewals, and revisions toInstitutional... ...Practices. Knowledge of medical terminology. Demonstrated...Work at office
$114k - $228k
...and products in diagnostics, medical devices, nutritionals and branded... ...and peripheral stents.This **Regulatory Affairs Manager** position is... ...clinical strategy and submission activities* Anticipate regulatory... ...communicate verbally and in writing, prepare, and negotiate both...Work experience placementShift work$157k - $271.4k
.... Job Function: Regulatory Affairs Group Job Sub... ...for an Associate Director, Regulatory Affairs to... ...product development, submission, approval, and LCM activities... ...affairs experience in medical devices including... ...Preferred Skills: Business Writing Compliance Risk...For contractorsLocal areaImmediate startRelocation packageFlexible hours3 days per week$244k - $305k
...developer to serve as Senior Director of Clinical Development in... ...pivotal studies including regulatory submissions. You will play a vital role... ...level, oversee the conduct of medical/safety data reviews and... ...of trial design, protocol writing/ICF (writing or amendment),...Full timeLocal area$210.38k - $272.25k
...possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and... ...strategy and execution for major global submissions, significant post-approval changes,... ...innovative medicines in areas of unmet medical need. With each new discovery and...Full timeFor contractorsLocal area$280k - $310k
...it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... .... The position will be responsible for all CMC-related submissions: strategic planning, execution, and ensuring quality and accurate...Local area$211k - $293k
...complex matters (including litigation, internal investigations, and regulatory requests). This includes overseeing intake, execution of... ...responses, cross-functional stakeholder management, and final submission approvals.Lead the development of project, program, and portfolio...- Page Mechanical Group, Inc. is seeking a Compliance Director in Palo Alto to lead a centralized enterprise-wide compliance program and ensure adherence to healthcare and regulatory standards. The role reports to executive leadership with direct access to the Board Audit...
$66.52 - $88.14 per hour
...Planning & Design team as a Project Manager - Regulatory & Licensing, where your expertise... ...budget, make financial projections and write reports. Ability to ensure project compliance... ..., political beliefs, marital status, medical condition, genetic information, veteran...Hourly payContract workFor contractorsWork experience placementLocal area$194k - $199k
...and resolving serious unmet medical needs. Summit believes in building... ...studies, including: Regulatory Studies Non-small Cell Lung... ...Overview Of Role The Associate Director, Regulatory Affairs, CMC is... ...oversees preparation of regulatory submissions in collaboration with CMC,...Work at office- ...Senior Project Manager/Clinical Evaluations to support regulatory submissions for medical devices. This on-site role focuses on CER development, review... ...Affairs, and Quality teams. The CER PM will lead writing and oversight of CERs, CEPs, PMCF plans, and related documents...
$194k - $199k
...of life, and resolving serious unmet medical needs. At Summit, we believe in building... ..., FL Overview of Role The Associate Director, Regulatory Affairs, CMC, is responsible for coordinating... ...and oversee preparation of regulatory submissions in collaboration with other...Work at office$212k - $318k
...Functions/ResponsibilitiesThe Associate Medical Director / Global Safety Physician is... ...organization as well as with external Regulatory Authorities. This individual, under supervision... ...MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC...Full timeContract workWork experience placementWorldwideFlexible hours$186k - $233k
...Director Clinical Operations Summit Therapeutics Inc. is a biopharmaceutical... ...patients with serious unmet medical needs. The Director will... ...within budget, timelines, regulatory, and quality standards. Responsibilities... ...of quality assurance, SOP writing, CAPA, eTMF, and inspection...Full time$259k - $314k
...cross-functional stakeholders (Clinical Development, Safety, Regulatory, Biometrics, Clinical Supply, CMC, Translational) to align on... ...training for compliance with GxP standards.Lead or assist in writing, reviewing, and/or approving clinical project deliverables such...Flexible hoursShift work
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