Senior CTA Job at Solomon Page (South San Francisco)

Senior CTA

As a Senior CTA at ICON, you will support the management and monitor of clinical...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research
Experience in clinical research, site management, or monitoring, with a solid understanding of clinical trial processes and GCP guidelines
Strong organizational and project management skills, with the ability to handle multiple priorities and deadlines
Excellent analytical skills and attention to detail, with a focus on maintaining high-quality standards
Exceptional communication and interpersonal skills, with the ability to build and maintain effective relationships with site personnel and cross-functional teams

Job Responsibility

Coordinating monitoring activities at clinical trial sites, ensuring adherence to study protocols and timely resolution of site-related issues
Assisting in the preparation and review of regulatory documents, ensuring all site activities are compliant with GCP and applicable regulations
Collaborating with cross-functional teams to facilitate effective communication and support for trial sites throughout the study lifecycle
Tracking site performance metrics, analyzing data, and providing reports to enhance site management efficiency
Participating in training initiatives and mentoring junior staff to support their development in clinical trial management

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Senior CTA

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field.
Prior experience or strong interest in clinical research.
Knowledge of clinical trial processes, regulations, and guidelines.
Experience working in a high-volume environment while maintaining both organization and the ability to multitask
Excellent time and priority management, ability to work efficiently under pressure
Independently managed high quality support and coordination of tasks under own responsibility
Reliable, conscientious and confidential
Motivated, shows initiative, is proactive and able to work independently as well as in a team
Worked in an international/ multicultural matrix environment
Excellent oral and written communication in English as well as administrative and coordination skills

Job Responsibility

Meeting coordination & assistance (including Meeting Minutes and Action& Decision Log)
Invoice processing & budget tracking
Create and maintain Trial Team & Vendor List
Perform CTMS data entry & QC
Coordinate Trial Oversight Plan Reconciliation
Oversight for Translational vendors
Support Data & Safety Monitoring Committee activities
Contribute to activities for Inspection Readiness and Inspection preparation
Create & manage System Access Tracker
Assist for internal Quality issues in internal Quality Management System

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.

Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

South Africa , Bloemfontein

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a science discipline
Background in clinical trial management
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Job Responsibility

Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
May be involved in local, regional, and/or global projects

Fulltime

New

Head of Tax

Lotus is embarking on an exciting transformation journey, and taxation plays a c...

Location

United Kingdom , Hethel

Salary:

Not provided

Lotus UK Manufacturing

Expiration Date

Until further notice

Requirements

Professional accountancy or tax qualification (ACA, ACCA, CTA or equivalent)
Strong in-house corporate tax experience covering areas such as Corporation Tax, VAT and Employment Taxes (PAYE)
Deep understanding of tax compliance, governance and risk management
Experience preparing tax accounting disclosures and supporting financial reporting requirements
Strong analytical and numerical skills with the ability to interpret complex legislation and translate it into practical business solutions
Excellent communication and stakeholder management skills, with the ability to influence at all levels of the organisation
Proven ability to drive change, improve processes and embed effective controls

Job Responsibility

Lead the development, review and implementation of the Group Tax Strategy, Tax Policy and wider tax governance framework
Establish and maintain tax governance processes, including tax frameworks, risk matrices and supporting documentation
Review and enhance tax controls within accounting and financial systems
Prepare and oversee tax accounting disclosures and Group reporting obligations
Drive tax planning initiatives while ensuring full compliance with applicable legislation and Group policies
Identify and implement tax-efficient structures and opportunities to support current and future business activities
Monitor changes in tax legislation and communicate their impact across the business, ensuring effective implementation where required
Act as the primary point of contact for HMRC and equivalent tax authorities across all operating regions
Ensure all tax returns and submissions are completed accurately and on time, maintaining Lotus's reputation as a trusted and compliant organisation
Develop and maintain the Group Tax Risk Register, including associated controls, processes and documentation

What we offer

25 days holiday plus bank holidays
Pension scheme access
Annual bonus - non contractual
Private Healthcare
Access to the Employee Car Ownership Scheme
Group income protection based on length of service
Family Friendly policies
Exclusive Employee discount, wellbeing and recognition platform #ForUSLOT

Fulltime

New

Corporate Tax Associate Director

Every day our teams help people in businesses and communities to do what is righ...

Location

United Kingdom , Manchester; Reading; Birmingham; Bristol; Milton Keynes; Gatwick; London; Cardiff

Salary:

Not provided

Grant Thornton UK LLP

Expiration Date

Until further notice

Requirements

Professional qualification (ATT, CTA, ACA, ICAS or ACA) with post qualification experience
Confident managing a portfolio of tax clients
Strong UK corporation tax technical skills, including leading domestic and international advisory projects, and experience with tax provisioning / interim and full year group reporting
Strong corporate tax compliance experience – experience in advising and awareness of the hybrid and other mismatch rules, interest deductibility, controlled foreign companies regime, Pillar 2, etc
A track record of leading projects, with a focus on accountability, high quality and timely delivery
Self-motivated and strong team player
Excellent interpersonal skills are required in addition to strong oral and written communication skills
Experience of coaching and developing more junior team members
A desire to network and play an active part in the growth of the broader team
You'll apply critical reasoning to bring clarity and insight

Job Responsibility

Advising a broad range of clients on a range of tax issues, covering a broad range of compliance and advisory projects
Leading client relationships and, together with the senior team, deliver solutions for client advisory projects
Managing the preparation of tax provisions and ensuring tax reporting obligations and compliance deadlines are met
Develop and lead your own client portfolio, ensuring a high level of client service
Work closely with our colleagues across the Grant Thornton’s tax practice, to identify opportunities from both new and existing clients
Proactively train and develop more junior members of the team, including through the delivery of bespoke training sessions
Lead from the front in regards to delivering client work, engaging with the wider Tax teams to ensure correct skill utilisation on all projects
Actively contribute to business development activities by proactively managing existing relationships and pitching work to new clients. You will support the partner and director team on proposals. You’ll actively grow the business by being present in the market and demonstrating our capabilities to clients and targets
Have a thorough understanding and adhere to the firm’s risk management and quality procedures

What we offer

Life cover
Income protection
Matched pension
Screening
Dental and eye care
Doctor@Hand
Mortgage advice
Will writing
Investment accounts
Buying holiday

Fulltime

Director Regulatory Affairs

As Director Regulatory Affairs you will report to the Chief Regulatory Affairs O...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Education in the natural sciences space with an MSc degree in Pharmacy, Chemistry or similar
Ideally 10+ years’ experience in industry and 7+ years in Regulatory Affairs
Experience in preparing regulatory strategies/regulatory development plans, highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
Experience with clinical trial submissions and approvals
Previous experience in a senior regulatory role, including health authority interactions, e.g. FDA and EMA meetings is required, and experience with BLA/MAA dossier preparation and submissions is desirable
In-depth understanding of regulations and guidelines governing all phases of drug development
Highly resourceful team-player, with the ability to be also extremely effective independently
Strategic mindset, innovative yet pragmatic/solution-oriented thinking, at the same time keen to also work in an operational role with attention to detail
Strong written and oral communication skills
comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.

Job Responsibility

Lead and contribute to regulatory strategies for assigned projects that expedite development, maximize the probability of success and mitigate risks
Play a hands-on role in planning, preparing and coordinating regulatory documents for submission to global health authorities as part of regulatory filings, such as CTAs/INDs, amendments, annual updates, paediatric investigation plans, orphan drug applications, fast track applications, responses to health authority information requests and BLAs/MAAs
Managing and leading the planning and preparation of meeting requests and meeting packages for health authority interactions for assigned projects
Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
Provide regulatory leadership and guidance to cross-functional project teams and lead the development, strategy and execution of regulatory submission documents while working collaboratively with the project team including a variety of personnel and staff
Liase with internal QA and CMC teams ensuring regulatory requirements are consistently met across QA and manufacturing functions.

Fulltime

Corporate Tax Director / Associate Director

Our tax professionals draw on their comprehensive experience to deliver business...

Location

United Kingdom , Greater Manchester

Salary:

Not provided

BDO UK LLP

Expiration Date

Until further notice

Requirements

A degree level education and/or CTA and/or ACA qualified or equivalent with demonstrable post qualified experience
An interest and experience of delivering the Tax strategic framework with regular involvement with tax planning and complex tax issues
Ability to manage the successful delivery of commercially viable and technically excellent advice to a variety of clients involving tax due diligence, structuring, international and other advisory work and including liaising with specialists in other tax teams and overseas BDO offices to manage their input
Ability to prepare proposals for new work, including researching target client companies and on technical issues to identify new solutions
Experience of people management
Experience of leading large scale or complex projects within own area of expertise

Job Responsibility

Providing Tax Advisory services to start-ups and scale-ups, to private businesses and FTSE listed multinationals
Working pro-actively, managing your own tasks
Collaborating with others, communicating regularly with senior managers, Directors, and BDO's Partners to enable us to serve our clients effectively
Identifying and drawing attention to opportunities for enhancing our delivery and providing additional services to our clients

What we offer

Agile working
Collaboration spaces
Career development programs
Mentoring and coaching
Health and wellness programmes
Pension plan
Private medical
Income protection plan
Holidays (ability to purchase up to 10 days of additional leave)
Bike to work scheme

Fulltime

Senior Associate - Regulatory Affairs

Let’s do this. Let’s change the world. In this vital role you will assist the US...

Location

United States

Salary:

83974.90 - 113613.10 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
Bachelor’s degree and 2 years of Regulatory Affairs experience
Associate’s degree and 6 years of Regulatory Affairs experience
High school diploma / GED and 8 years of Regulatory Affairs experience

Job Responsibility

Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
Create and maintain product regulatory information and history documents through Amgen systems
Appropriately archive regulatory documents and agency communications
Collaborate with CRO’s / partners to support site initiation
Complete regulatory forms to support agency communications
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Assist in template development and maintenance

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

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Senior CTA

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