Senior Issue Lead - FSP Job at Parexel

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP
Extensive clinical/scientific writing skills
Scientific background essential
writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar
Advanced word processing skills, including MS Office (expertise in Word)
software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel)
Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation
Excellent interpersonal, verbal, and written communication skills
Ability to consistently produce documents of high quality

Job Responsibility

Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy
Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable
Perform literature searches/reviews as necessary to obtain background information and training for development of documents
Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing
Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
Confirm data consistency and integrity across the document
Prepare documents for publishing readiness, when applicable
Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable
Provide suggested alternative content when contributors provide content that does not meet document needs

What we offer

Foster a culture of inclusivity, collaboration, and support
Continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team
Development and promotion based on global standards and your personal development plan
Supportive and inclusive environment
Career growth and development
Mentorship
Flexible work
Diverse projects
Culture of excellence
Global exposure

Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: ...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience
Degree and in-depth regulatory experience and/or related to the affiliate
Depth knowledge of affiliate legislation and regulations relating to medicinal products
English and Czech and/or Slovak language working proficiency
Good negotiation and Influencing skills
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders
Ability to manage multiple activities and set priorities
Ability to lead teams and develop effective teams

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
First point of contact for interactions with local regulatory agency(ies)
Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates
Represent Regulatory on the affiliate leadership team
Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies)
Supervise and oversight for one or more regulatory staff
Manage and liaising with distributors (if applicable)
Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable
Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate

Fulltime

Biostatistical Programming Senior Manager

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States

Salary:

157896.85 - 213625.15 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years Statistical Programming experience
Master’s degree and 6 years Statistical Programming experience
Bachelor’s degree and 8 years Statistical Programming experience
Associate’s degree and 10 years Statistical Programming experience
High school diploma and 12 years Statistical Programming experience

Job Responsibility

Maintain and develop re-usable software utilities for GBS and GSP
Provide technical leadership and guidance for programming teams
Oversee FSP programming team
Partner with IS to maintain and enhance GSP systems
Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications
Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data
Adhere to functional standards, processes and methods across all projects
Create, maintain, and review key SDLC documents -Requirements, Operational Qualification, Installation Qualification, and Design documents
Create, maintain, and review end-user documentation (e.g., user guides, training materials)
Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Trial Delivery Management (Base)

As a TDM at ICON, you will be responsible for leading and coordinate project act...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in project management, business, or a related field is preferred, with significant experience in project management and team leadership
Proven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints
Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks
Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations
Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous
Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement
Willingness to travel as required (approximately 30%)

Job Responsibility

Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery
Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration
Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track
Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives
Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Clinical Data Analyst

Parexel is currently seeking a Senior Clinical Data Analyst to join us in either...

Location

United Kingdom; Poland; South Africa , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's Degree required, preferably in the scientific/healthcare field
Proven leadership experience
Good project management skills and a proven ability to multitask
At least five years' or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry
Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors
A high level of Phase I experience is essential
A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Strong English language written and verbal communication skills
Able to travel to meetings or training seminars on occasion

Job Responsibility

Lead a large clinical study or a series of related studies with minimum guidance
Represents Data Management on the CTWG for assigned studies
Provide mentoring and training to lower-level Data Management staff assigned to your studies
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
build effective relationships with CRO / vendor counterparts
Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
Be able to perform a thoroughly detailed review of eCRF data requirements
Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines
Lead the development of data edit check specifications and data listings
Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards

What we offer

annual performance-based bonus plan
annual salary review
total rewards incentives

Fulltime

Local Study Operations, Senior Manager

Location

Australia , Sydney

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master's degree & 6 years of clinical execution experience OR Bachelor's degree & 8 years of clinical execution experience OR Associate's degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the skill development of Local Study Operation Managers (LSOM's), ensuring effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio

What we offer

health, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities

Fulltime

Senior Clinical Site Manager

Senior Clinical Site Manager (SCRA) – Home-Based | Adelaide or Melbourne | Rare ...

Location

Australia , Melbourne

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Experience as a CRA II or Senior CRA within a CRO, biotech, or pharmaceutical environment
Strong site-facing experience with proven ability to build and maintain relationships
Excellent problem-solving skills and ability to think creatively to overcome recruitment challenges
High attention to detail with experience reviewing data and identifying site issues
Outstanding communication skills with the ability to adapt style across different audiences
Solid knowledge of ICH-GCP and clinical trial processes
Ability to work independently in a fast-paced, global environment

Job Responsibility

Build, develop, and maintain strong relationships with investigators and site staff
Lead all aspects of site management, including selection, initiation, monitoring, and close-out visits
Identify site performance trends and proactively address recruitment or operational challenges
Review data and site metrics to identify risks and implement solutions
Act as the primary point of contact for study sites
Support study delivery through collaboration with Project Managers, vendors, and internal teams
Contribute to study start-up activities, documentation, and regulatory submissions
Ensure studies remain audit and inspection ready at all times
Drive innovative approaches to improve site engagement and patient recruitment

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Parttime

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

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Senior Issue Lead - FSP

Job Description

Job Responsibility

Requirements

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