Regulatory Documentation Specialist - eDMS & Submissions
$91.5k - $134.2kIpsen Innovation (SAS)
Ipsen Innovation (SAS) seeks a Document Specialist in Cambridge, MA, to support Regulatory and submission teams in electronic regulatory submissions globally. The role involves ensuring documents are completed to high standards and mentoring authors on compliance with standard operating procedures. The ideal candidate will have 5+ years of experience in a CRO or pharmaceutical environment and a Bachelor's degree in Life Sciences or related field. This position offers an annual salary range of $91,500-$134,200 and a comprehensive benefits package. #J-18808-Ljbffr Ipsen Innovation (SAS)
$91.5k - $134.2k
Ipsen Biopharmaceuticals Inc. is seeking a Document Specialist to support regulatory submissions by ensuring documents are high-quality and ready for submission... ...of experience, strong skills in Microsoft Word and eDMS tools, and a degree in a relevant field. A...Suggested- Ipsen is looking for a Document Specialist in Cambridge, MA, to support regulatory teams by ensuring high-quality electronic submissions. This role involves training authors and managing documents within an eDMS environment. The ideal candidate will have over 5 years of...Suggested
- ...Ipsen Group is seeking a Document Specialist in Cambridge, MA to support regulatory submissions and ensure documents are submitted in a Ready For Submission (RFS) format... ...responsible for training authors and managing eDMS properties. The ideal candidate has over 5 years...Suggested
- ...Document Specialist Ipsen is a mid‑sized global biopharmaceutical company with a focus on transformative... ...Document Specialist will support Regulatory and submission teams to enable electronic... ...Technical Competencies Support to the eDMS and Authoring tool users, as...SuggestedWork at officeLocal areaWorldwideFlexible hours
$91.5k - $134.2k
Document Specialist - Ipsen Innovation (SAS) Support regulatory and submission teams by ensuring that documents are completed in high‑quality, ready‑for‑submission (RFS) format... ...Provide training, coaching and mentoring to eDMS and authoring tool users, including CRO staff,...SuggestedTemporary workWork at officeFlexible hours$94k - $150k
...Senior Regulatory Affairs Specialist The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams and authorities... ...include coordinating and preparing regulatory submission documents for agencies such as the FDA, Health Canada, EU Competent...Full timeWork at officeImmediate startWork visaRelocation package3 days per week$66.5k - $88.02k
What Regulatory Affairs contributes to Cardinal Health Regulatory provides... ...writing and regulatory submissions as well as clinical research... ...The Sr Regulatory Affairs Specialist will support the Medical Solutions... ...on 510(k), EU Technical Documents, and International STEDs....Temporary workWork experience placementWork at officeLocal areaImmediate startRemote workFlexible hours$85k - $95k
...aspire to alter the course of lives. Regulatory and Clinical Specialist The Regulatory and Clinical... ...promotional materials and support regulatory submissions for the active implantable medical... ...and approval process for assigned documents (CEP, CER, etc.) within timelines,...Remote workWorldwideFlexible hours- ...cost. Job Description Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines... ..., validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high...Work at officeImmediate start
$36.06 - $40.87 per hour
Job Responsibilities Assists with the development of various documentation products in support of assigned program/project system. Collaborates with appropriate team members to develop required documentation materials (end-user manuals, technical documents, graphics, etc...Contract workWork at office$75k - $137k
...basis, including the assurance that policy files are properly documented and organized according to the department’s standards.... ...Business and Renewals policies within required timeframe Handle new submissions including clearance, submission set up and requests for...Full timeFor contractors- ...quote-to-bind-to-issuance execution Primary Responsibilities: Submission intake, data validation, quote/binder/policy/endorsement... ...information. Coordinate with broker partners to obtain required documentation and details needed for processing. Support account setup activities...Work at office
£45k per year
...UK's most environmentally sensitive catchments. As Senior Regulatory Data Specialist, you'll be central to ensuring abstraction activities are... ...across the region.Produce high-quality regulatory submissions, including abstraction returns and self-reportingBecome the...Full timeFlexible hours- ...including managing registration, academic records and implementing all activites required for PhD/Master theses format review and final submissions. This includes ensuring compliance with FERPA and other relevant laws and regulations. Responsible for managing and...Permanent employmentTemporary workSummer workWork at officeRemote work
$30 - $35 per hour
...and process improvements Responsibilities Develop and maintain documentation for student information systems and reporting tools... ...Manage compliance reporting, including bi-weekly enrollment submissions and audit preparations Coordinate with internal teams on scheduling...Work at office- ...IT staffing company in Boston is seeking an administrative professional. The role involves tracking and reviewing change control documentation and assisting with quality documents to ensure compliance. Candidates should have a high school diploma and 1-3 years of...
$134k - $348.5k
Overview As an Asset and Wealth Management External Audit - Regulatory Reporting Specialist - Director, you will play a pivotal role in guiding... ...mitigate risks effectively Oversee the preparation and submission of regulatory reports in alignment with industry standards...$134k - $348.5k
The Opportunity As an Asset and Wealth Management - Regulatory Reporting Specialist - Director, you will play a pivotal role in guiding clients... ...mitigate risks effectively Overseeing the preparation and submission of regulatory reports in alignment with industry...H1b$17.57 - $21.96 per hour
Tufts Medicine in Boston is seeking a Medical Scribe to support physicians by documenting patient histories, physical exams, and medical procedures in real time. This role is essential for maintaining accurate medical records and improving the efficiency of patient care...$30 - $34 per hour
Facade Today is seeking a Document Control Specialist for their Boston headquarters to manage MEP-related construction documentation. This role... ...as maintaining the document control system, tracking submissions, and coordinating with engineering teams. The ideal candidate...Hourly payFlexible hours- ...Talent. Job Description This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation,... ...contributes to the generation of product regulatory strategy documents (for products in phase 1-3 clinical development), labeling...
$40.4k - $67.4k
....Compliance Specialist II page is loaded## Compliance Specialist IIlocations... ...open items. Collate final documents, update BSS and keep all... ...client and preparation and submission of all files and related... ...understanding and appreciation of regulatory functions and issues....Permanent employmentWork at officeLocal area$260k - $365k
...Holland & Knight LLP is seeking a healthcare regulatory associate for its Boston or Nashville office. Candidate must have at least 3... ...individual ’s qualifications and experience. We are not accepting search firm submissions for this position at this time. #J-18808-Ljbffr...Work at office- ...with preparing global shareholder ownership filings for submission to applicable regulatory authorities as needed. Assist in the implementation and... ...restrictions. Identify compliance restrictions from governing documents for new accounts and amendments to existing accounts....Work at officeRemote workMonday to FridayFlexible hoursDay shift
- ...Certification / Compliance Specialist to join the Product Compliance... ...activities, agency submissions, sustaining of listings, and... ...product certification with regulatory agencies. Primary Responsibilities... ...including annual renewals, documentation updates, and responding to...For contractorsWork at officeRemote work
- ...Cardinal Health is looking for a Sr Regulatory Affairs Specialist to join their Medical Solutions Regulatory Affairs team. This remote position is responsible for ensuring regulatory compliance across a diverse portfolio of medical devices, including new product development...Remote work
- ...University to facilitate proposal submission, award acceptance and... ...the award. The Compliance Specialist supports audit, compliance,... ...lifecycle, including planning, documentation, response development, and... ...also involves monitoring regulatory updates, integrating...Work at officeRemote work
$80k - $90k
...Title: Regulatory Affairs Associate Reporting to: Regulatory Affairs Manager We are seeking... ..., preparing and submitting regulatory documents, and providing guidance and support to... ...organization. Ensure that all regulatory submissions are of high quality, complete, and...Full timeLocal areaRemote work- ...an experienced and highly motivated Regulatory Affairs Specialist who will be a contributing member of... ...and submits international regulatory submissions to obtain and maintain regulatory... ...regulatory requirements and guidance documents to ensure compliance Coordinizes regulatory...Work at officeLocal area
$116.7k - $132k
...plan. They will monitor federal and state regulatory requirements and industry developments and... ...check requests, cover letters and supporting documentation as required for delivery to Chief Compliance Officer for final submission to payers Review government and...Work at officeFlexible hours
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