Senior Medical Writer

3 weeks ago

Billerica, United States PAREXEL Full time

PXL FSP is seeking to hire a Sr. Medical Writer

Job Purpose
The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.

Key Accountabilities

Leadership
* Leads cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions
* Coordinates and delivers document kick-off meetings with contributors or representatives from cross-functional groups
* Coordinates activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines
* Ensures communication between members remains open and information is disseminated appropriately
* Possible participation in the orientation and coaching of junior team members


Regulatory Document Authoring
* Develops, coordinates, and oversees work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines
* Develops and maintains timelines in project plans, using project tracking application following standard templates
* With minimal guidance from senior members of writing staff, prepares clinical study reports (CSRs), protocols, investigator brochures (IBs), submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development
* Manages messaging for consistency with historical information and in alignment with agreed-upon strategy
* Applies lean authoring principles as part of document development and, when applicable, structured content management (SCM) text libraries as part of authoring process
* Ensures adherence to standard content, lean authoring, and messaging across team members
* Works as an active member of cross-functional teams representing Medical Writing
* Conducts appropriate literature searches, as needed


Compliance with Parexel Standards
* Complies with required training curriculum
* Completes timesheets accurately as required
* Submits expense reports as required
* Updates CV as required
* Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements


Skills
* Focused writing and editing following defined processes and templates
* Expert level authoring in MS Word, understanding of MS Word functionality, and works with Word
add-ins that facilitate the management of fonts, styles, references, etc
* Follows directions, templates, and structured processes for delivering documents for review and
finalization
* Participates in Medical Writing department initiatives, as appropriate.
* Researches regulatory requirements to remain current in the regulatory landscape
* Shares lessons learned and best practices
* Ability to work independently
* Ability to move across therapeutic areas to support business continuity and resource needs
* Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion
* Customer focused with communication skills commensurate with a professional working
environment as well as effective time management, organizational, and interpersonal skills
* Fluent in reading and writing American English


Knowledge and Experience
* Minimum 5 years in writing regulatory documents supporting global filings
* Oncology and/or Infectious Disease/Vaccines experience
* Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as
those from the EU and US
* Regulatory filing experience with a focus in authoring a broad set of different clinical document
types that support regulatory filings such as protocols, amendments, CSRs, and common
technical document summary documents with a preference for experience with Module 2.7, 5.2,
CSRs, protocols, amendments, and IBs
* Understanding of clinical development process from program planning to submission, including
clinical trial design as well as medical practices regarding procedures, medications, and treatment
for different disease states
* Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements
* Ability to interpret data and apply scientific knowledge to support regulatory document writing (i.e.,
IBs, protocols, amendments, CSRs, clinical summaries) as well as build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science
* Ability to develop and use story boards to drive statistical output planning, link data results to key
messages, and develop templates as starting points for authoring
* Experience working on cross-functional teams with the ability to drive document content to support
lean authoring
* Experience working in collaborative authoring tools and review tools, project tracking applications
and document management systems; managing workflows eApproval/esignatures; and familiar with SCM and ability to author in an SCM environment using text libraries
* Flexibility in adapting to new tools and technology with capability of providing insight, alternatives, and suggestions based on previous experiences
* Capable of training writers/authors on the use of templates, guidelines, and tools


Education
Bachelor's degree or equivalent (Life Science preferred)

#LI-REMOTE

  • Medical Writer

    6 days ago

    Billerica, United States Parexel International Corporation Full time

    Medical Writer II Location: Home Based from the continental US (East Coast Region)Parexelis one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We are...

  • Medical Writer

    1 day ago

    Billerica, United States Parexel International Corporation Full time

    Medical Writer II Location: Home Based from the continental US (East Coast Region)Parexelis one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We are...

  • Medical Writer II

    1 week ago

    Billerica, United States PAREXEL Full time

    Medical Writer II Location: Home Based from the continental US (East Coast Region) Parexelis one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We...

  • Principal Medical Writer

    2 weeks ago

    Billerica, United States PAREXEL Full time

    Currently hiring a Principal Clinical Regulatory Medical Writer to work remote from any location in the US. (Full time) The Principal Medical Writer will research, create, and edit all documents associated with clinical research. The Principal Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage...

  • Compassionate Senior Care Specialist

    7 days ago

    Billerica, Massachusetts, United States Brightview Senior Living Full time

    Job OverviewWe're dedicated to delivering exceptional care and services at Brightview Senior Living.About Our CommunityWe take pride in being recognized as one of Fortune Magazine's 100 Best Companies to Work For in a notable year. We lead the industry with a passion for delivering top-notch services and groundbreaking care, setting us apart from other...

  • Senior Financial Manager for Homecare Services

    7 days ago

    Billerica, Massachusetts, United States Guardian Angel Senior Services Full time

    Guardian Angel Senior Services, a Massachusetts-based company with a commitment to providing exceptional care, is seeking an experienced Senior Financial Manager to join its team. This role offers a unique opportunity to work in the homecare industry, where attention to detail and strong financial management skills are essential.Job Summary:We are looking...

  • Team Lead

    6 days ago

    Billerica, United States Parexel International Corporation Full time

    Parexel‘s MedCom Scientific Services is seeking a remote Scientific Team Lead /Global Publications Lead with Oncology (solid tumor) experienceJOB DESCRIPTIONKnowledge and Experience:10 years of extensive Medcom Agency experience and minimum 1 year management experience of a scientific teamIndepth Oncology (Solid tumor) publications experienceBroad...

  • Scientific Team Lead

    2 weeks ago

    Billerica, United States PAREXEL Full time

    Parexel's MedCom Scientific Services is seeking a remote Scientific Team Lead /Global Publications Lead with Oncology (solid tumor) experience JOB DESCRIPTION Knowledge and Experience: 10 years of extensive Medcom Agency experience and minimum 1 year management experience of a scientific team Indepth Oncology (Solid tumor) publications experience Broad...

  • Team Lead

    1 day ago

    Billerica, United States Parexel International Corporation Full time

    Parexel‘s MedCom Scientific Services is seeking a remote Scientific Team Lead /Global Publications Lead with Oncology (solid tumor) experienceJOB DESCRIPTIONKnowledge and Experience:10 years of extensive Medcom Agency experience and minimum 1 year management experience of a scientific teamIndepth Oncology (Solid tumor) publications experienceBroad...

  • Senior Medical Director, Global Therapeutic Area Medical Head, Nephrology Expert

    4 weeks ago

    Billerica, Massachusetts, United States PAREXEL Full time

    Job SummaryThe Senior Medical Director, Global Therapeutic Area Medical Head, Nephrology plays a pivotal role in driving medical and scientific leadership both internally and externally with clients in support of overall company objectives.Key ResponsibilitiesDeliver medical and scientific expertise to clients and colleagues from other departments in the...

  • Wellness Nurse

    1 week ago

    Billerica, United States Brightview Senior Living Full time

    Job DescriptionAbout UsWe are honored that Brightview Senior Living has been recognized as one of Fortune Magazine's 100 Best Companies to Work For in 2023!!We're in the top 100 across all industries, and all companies no matter how large or small...and we're the ONLY Senior Living company on the prestigious list!OverviewWork with a great team where you feel...

  • Wellness Nurse

    3 days ago

    Billerica, United States Brightview Senior Living Full time

    About Us We are honored that Brightview Senior Living has been recognized as one of Fortune Magazine's 100 Best Companies to Work For in 2023!!We're in the top 100 across all industries, and all companies no matter how large or small...and we're the ONLY Senior Living company on the prestigious list! Overview Work with a great team where you feel...

  • Certified Nursing Assistant

    1 month ago

    Billerica, United States Brightview Senior Living Full time

    Job DescriptionOverviewAbout UsDoes being kind and compassionate come naturally to you?Do you thrive on the ability to help others and make a difference in the lives of others?If this sounds like you, then Brightview Senior Living is for you!ResponsibilitiesWhat you will get to do as a Caregiver (HHA OR CHHA ) at Brightview?Use your compassion to provide...

  • Controller

    2 weeks ago

    Billerica, United States Guardian Angel Senior Services Full time

    Guardian Angel Senior Services is currently looking for a strong multi-tasker with excellent communication and organization skills to take on the role of Controller. The Controller will be an integral part of the management team working closely with the owners and senior management staff. The Controller provides superior customer service through written and...

  • Controller

    3 weeks ago

    Billerica, United States Guardian Angel Senior Services Full time

    Guardian Angel Senior Services is currently looking for a strong multi-tasker with excellent communication and organization skills to take on the role of Controller. The Controller will be an integral part of the management team working closely with the owners and senior management staff. The Controller provides superior customer service through written and...

  • Controller

    3 weeks ago

    Billerica, United States Guardian Angel Senior Services Full time

    Guardian Angel Senior Services is currently looking for a strong multi-tasker with excellent communication and organization skills to take on the role of Controller. The Controller will be an integral part of the management team working closely with the owners and senior management staff. The Controller provides superior customer service through written and...

  • Senior Manager Quality Assurance Lead

    4 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    Job Title: Senior Manager Quality AssuranceJob Summary: We are seeking a highly skilled and experienced Senior Manager, Quality to support our Manufacturing Quality team at Access Vascular Inc.About the Role: This role is critical in ensuring that our products meet the highest standards of quality and compliance. The ideal candidate will have a strong...

  • Senior Calibration Technician

    4 weeks ago

    North Billerica, United States Lantheus Medical Imaging Inc Full time

    Job Title: Senior Calibration TechnicianAt Lantheus Medical Imaging Inc, we are seeking a skilled Senior Calibration Technician to join our Metrology department. As a key member of our team, you will be responsible for performing calibration, maintenance of calibration records and notifications, and troubleshooting/repair of mechanical/electrical devices.Key...

  • Senior Manager, Quality

    3 weeks ago

    Billerica, United States Access Vascular Inc Full time

    Job Description We are seeking a highly skilled and experienced Senior Manager, Quality to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance. The ideal candidate will have a strong background in quality management within the medical device industry and a proven...

  • Senior Manager, Quality Assurance

    4 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    We are seeking a highly skilled and experienced Senior Manager, Quality Assurance to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance.The ideal candidate will have a strong background in quality management within the medical device industry and a proven track...