Documentation Specialist

2 weeks ago

Somerville, United States VCLS Full time
Document Specialist

We are seeking a detail-oriented and organized Document Specialist to join our team. The successful candidate will assist project teams with the preparation of regulatory documents and provide project management support. As a project team member, you will support prescribed activities for client and internal projects, adhering to strict timelines and quality standards.

Key Responsibilities:

Document Management:
  • Prepare and review regulatory documents, including protocols, clinical study reports, and regulatory submissions.
  • Prepare content plans, organize and categorize documents, ensuring accessibility and version control.
  • Incorporate draft edits with extreme attention to detail, create and finalize abbreviation tables, and manage literature references and citations.
  • Support e-publishing activities (formatting, creating eCTD compliant PDFs, hyperlinking, bookmarking, etc.).
Project Coordination:
  • Support project managers in coordinating activities related to regulatory submissions and project milestones.
  • Coordinate with cross-functional teams to ensure completeness and accuracy of submissions.
  • Track submission progress and address any queries or issues raised during the review process.
  • Coordinate, organize, and participate in project team meetings, as requested.
  • Conduct research for projects and archive project data in the knowledge management system at project closing.
  • Prepare documents, spreadsheets, invoices, and general administrative support to senior regulatory consultants.
Quality Assurance:
  • Stay up-to-date with regulatory guidelines and industry standards.
  • Conduct document audits to ensure compliance with regulatory requirements, regulatory style guide, and internal standards.
  • Implement corrective actions and continuous improvements to enhance document management processes.
Requirements

Who You Are:
    • Experience: Proven work experience in project management
    • Technology: Expert level proficiency in Windows and MS Office Suite
    • Values: Embody our core values - People, Innovation, Passion and Excellence.
    • Detail-Oriented: Possess a meticulous eye for accuracy and strong organizational skills.
    • Team Player: Thrive in a collaborative environment and demonstrate excellent communication skills.
    • Preferred, not required:
      • BS/BA
      • Experience within the pharmaceutical, life sciences or biotech industry
      • Knowledge of Adobe Acrobat (PDF optimization, bookmarks, hyperlinks), Endnote and eCTD software
Benefits

Why VCLS:
  • Make a Difference: Contribute to the development of life-saving therapies and accelerate progress in the field.
  • Learn and Grow: Work alongside industry veterans and gain invaluable mentorship.
  • Hybrid Flexibility: Enjoy the best of both worlds with a work-life balance that empowers you.
  • Dynamic Environment: Be part of a passionate team dedicated to client success and innovation.
  • Growth Potential: Build a rewarding career in a company that fosters continuous learning and development.


VCLS is committed to fostering a diverse and inclusive workplace. We are a proud equal opportunity employer and value the unique contributions of all individuals. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

  • Document Control Specialist

    4 weeks ago

    Somerville, Massachusetts, United States Global Channel Management Full time

    About the job Document Control SpecialistDocument Control Specialist needs 1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industryDocument Control Specialist requires:Bachelor\u0027s degree or equivalent experience is preferred.1 to 3 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required.Strong...

  • Document Control Specialist

    3 weeks ago

    Somerville, United States Piper Companies Full time

    Job DescriptionJob DescriptionPiper Companies is currently seeking a Document Control Specialist for an opportunity in Branchburg, New Jersey (NJ), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Document Control SpecialistInterface with internal and external team members to provide Quality Assurance...

  • Document Specialist

    2 months ago

    Somerville, United States Incredible Health Full time

    Hospitals on Incredible Health are actively hiring and accepting applications in the Somerville, NJ area for the following position: Document Specialist (RN). Nurses with experience in any of the following areas are strongly encouraged to apply: Clinical pathway, Navigator, or Utilization Review. Shift(s) available: day shift, night shift, and mid shift ...

  • Mental Health Nurse Specialist

    3 weeks ago

    Somerville, Massachusetts, United States Mass General Brigham Full time

    Mental Health Nurse Specialist Job Title:Mass General Brigham is seeking a highly skilled Mental Health Nurse Specialist to join our team in Somerville, Massachusetts.This full-time position involves providing exceptional patient care and participating in therapeutic milieu.Key Responsibilities:Mental Health Assessment: Conduct thorough assessments of...

  • Nurse Care Specialist

    4 weeks ago

    Somerville, Massachusetts, United States RWJBarnabas Health Full time

    Job Title: Nurse Care SpecialistJob Summary:We are seeking a skilled Nurse Care Specialist to join our team at RWJBarnabas Health. As a Nurse Care Specialist, you will be responsible for ensuring the delivery of safe and quality patient care. Your expertise will be utilized to perform, adapt, and safely demonstrate procedures required by patients according...

  • Nurse Specialist

    4 weeks ago

    Somerville, Massachusetts, United States RWJBarnabas Health Full time

    Job Title: Nurse SpecialistJob Summary:We are seeking a skilled Nurse Specialist to join our team at RWJBarnabas Health. As a Nurse Specialist, you will be responsible for delivering high-quality patient care in our Orthopedic Unit. Your expertise and compassion will make a significant difference in the lives of our patients.Key Responsibilities:Administer...

  • Regulatory Affairs Specialist

    4 weeks ago

    Somerville, New Jersey, United States Fladger Assoc. Inc. Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Fladger Assoc. Inc. The ideal candidate will have a strong background in regulatory affairs, with experience working on medical device projects.Responsibilities:Represent Regulatory Affairs by attending project team meetings,...

  • Nurse Care Specialist

    4 weeks ago

    Somerville, Massachusetts, United States BAYADA Home Health Care Full time

    BAYADA Home Health Care is seeking a skilled Nurse Care Specialist for a nursing job in a designated geographic territory.Job Description & RequirementsSpecialty: Home Health Discipline: RN Duration: Ongoing Employment Type: Staff $10,000.00 SIGN-ON BONUSNurse Care Specialist - Home Health VisitsFull-Time with Comprehensive Benefits Package ANDWork/Life...

  • Environmental Specialist

    1 week ago

    Somerville, United States Triumvirate Environmental Full time

    Environmental Specialist (Lab Pack Specialist)Triumvirate Environmental, one of the largest environmental services firms in North America, is seeking an Environmental Specialist for our Lab & Onsite Support Services (Lab/OSS) team. As an Environmental Specialist, youwill support our clients on-site by managing their hazardous waste programs & projects,...

  • Environmental Specialist

    2 weeks ago

    Somerville, United States Triumvirate Environmental Full time

    Environmental Specialist (Lab Pack Specialist)Triumvirate Environmental, one of the largest environmental services firms in North America, is seeking an Environmental Specialist for our Lab & Onsite Support Services (Lab/OSS) team. As an Environmental Specialist, youwill support our clients on-site by managing their hazardous waste programs & projects,...

  • Medical Records Specialist

    1 month ago

    Somerville, Massachusetts, United States Incredible Health Full time

    Incredible Health is actively hiring for a Document Specialist (RN) in the Somerville, NJ area. This role involves working with nurses who have experience in clinical pathway, navigation, or utilization review. The ideal candidate will have an ADN/ASN degree or higher and an active Registered Nurse license in New Jersey. Benefits include healthcare coverage,...

  • Sports Medicine Specialist

    4 weeks ago

    Somerville, Massachusetts, United States Mass General Brigham (Enterprise Services) Full time

    Job SummaryThe Mass General Brigham (Enterprise Services) is seeking a highly skilled Sports Medicine Specialist to join our team. As a key member of our Sports Medicine Program, you will be responsible for providing medical coverage of athletic training room duties and athletic events for a local high school athletic program.Key Responsibilities...

  • Regulatory Affairs Specialist

    4 weeks ago

    Somerville, New Jersey, United States Fladger Assoc. Inc. Full time

    Job DescriptionFladger Assoc. Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our project team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Represent Regulatory Affairs by attending project team meetings, providing regulatory...

  • Service Desk Support Specialist

    3 weeks ago

    somerville, United States Delphi-US, LLC - Peacemakers in the Talent War Full time

    Title: Service Desk Support Specialist (Contract)- Job#5229Location: Somerville, MAJob Description: Our client located in Somerville, MA has an immediate opening for a Service Desk Support Specialist to join their team. The Service Desk Support Specialist will act as the SME for workday when it goes live. They will not only be the primary contact for workday...

  • Service Desk Support Specialist

    3 weeks ago

    somerville, United States Delphi-US, LLC - Peacemakers in the Talent War Full time

    Title: Service Desk Support Specialist (Contract)- Job#5229Location: Somerville, MAJob Description: Our client located in Somerville, MA has an immediate opening for a Service Desk Support Specialist to join their team. The Service Desk Support Specialist will act as the SME for workday when it goes live. They will not only be the primary contact for workday...

  • Service Desk Support Specialist

    3 weeks ago

    Somerville, United States Delphi-US, LLC - Peacemakers in the Talent War Full time

    Title: Service Desk Support Specialist (Contract)- Job#5229Location: Somerville, MAJob Description: Our client located in Somerville, MA has an immediate opening for a Service Desk Support Specialist to join their team. The Service Desk Support Specialist will act as the SME for workday when it goes live. They will not only be the primary contact for workday...

  • Diagnostic Imaging Specialist

    4 weeks ago

    Somerville, Massachusetts, United States RWJBarnabas Health Full time

    Job Title: Diagnostic Imaging SpecialistJob Summary:RWJBarnabas Health is seeking a skilled Diagnostic Imaging Specialist to join our team. As a Diagnostic Imaging Specialist, you will be responsible for performing a variety of diagnostic imaging procedures, including computed tomography (CT) scans. You will work closely with our radiologists and other...

  • Nurse Care Transition Specialist Lead

    4 weeks ago

    Somerville, Massachusetts, United States Mass General Brigham Full time

    Care Transition Specialist Lead Job DescriptionMass General Brigham is seeking a highly skilled Care Transition Specialist Lead to join our team. As a key member of our Care Continuum Management team, you will be responsible for performing Care Transition Specialist duties, as well as analytical, administrative, and escalation duties for MGB Post-Acute...

  • Recovery Specialist

    6 months ago

    Somerville, United States Bay Cove Human Services Full time

    Recovery Specialist - Men's Residence - Highland Avenue Department Somerville, MA, USA Req #2032 Wednesday, March 20, 2024 Bay Cove Human Services’ mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the...

  • Histology Laboratory Specialist

    4 weeks ago

    Somerville, Massachusetts, United States US Tech Solutions Full time

    This position will be day shift. The successful candidate will be responsible for performing routine histology techniques, solution preparation, supply management, maintenance and operation of laboratory equipment and workstations, and good documentation practices in recordkeeping to support Quality Control Product Release Testing.This includes but is not...