Implementation & Activation Associate Director Job at Mindshare Worldwide (Sydney)

New

Clinical Scientist Associate Director – Late Development, Oncology

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

Location

Portugal , Lisbon

Salary:

79656.90 - 107771.10 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master's degree and 5 years of life sciences/healthcare experience
Bachelor's degree and 7 years of life sciences/healthcare experience

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into and implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

What we offer

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
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, including remote and hybrid work arrangements, where possible

Fulltime

New

Associate Director of Sales

Assists in leading the property’s segmented sales effort (e.g., group, transient...

Location

India , Udaipur

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

2-year degree from an accredited university in Business Administration, Marketing, Hotel and Restaurant Management, or related major
3 years experience in the sales and marketing or related professional area. OR 4-year bachelor's degree in Business Administration, Marketing, Hotel and Restaurant Management, or related major
1 year experience in the sales and marketing or related professional area.

Job Responsibility

Assists in leading the property’s segmented sales effort
assists in the implementation of the segment sales strategy and achieving segment revenue goals, property revenue goals and guest and employee satisfaction
conducts all day-to-day activities related to the sales function with a focus on building long-term, value-based customer relationships
achieves personal booking goals
works with sales leader to ensure understanding of sales strategy and effective implementation
assists in the development, implementation and sustaining of aggressive solicitation program
works with management team to create and implement a sales plan
assists with the development and implementation of promotions
provides positive and aggressive leadership to ensure maximum revenue potential
recommends booking goals for sales team members

Fulltime

Senior Manager / Associate Director, Engagement Platforms & Reporting

Our client, a leading global biopharmaceutical company is seeking a Senior Manag...

Location

United States , San Rafael

Salary:

66.00 USD / Hour

Tucker Parker Smith Group

Expiration Date

Until further notice

Requirements

Bachelor's degree from an accredited college or university required
4 years of experience in the pharmaceutical or biotechnology industry preferred
Relevant consulting or technology-focused experience may also be considered
Experience with pharmaceutical technology platforms such as Veeva, Salesforce, or similar systems preferred
Experience with measurement and reporting of medical affairs activities preferred
Experience managing projects involving IT, Legal, and Compliance teams
Demonstrated success working cross-functionally in complex, matrixed environments
Strong project management, communication, and stakeholder engagement skills

Job Responsibility

Oversee the development, implementation, evaluation, and maintenance of technology platforms, systems, and related training that support Medical Engagement activities within Global Medical Affairs
Support Medical Engagement Leads with platform implementation and ongoing system maintenance, with a strong focus on field medical systems
Develop and implement measurement frameworks and reporting capabilities to track and enhance the impact of medical affairs engagement activities
Lead reporting initiatives across GMAF, prioritizing analytics and insights aligned with organizational needs and strategic capabilities
Support execution of the GMAF roadmap through digital initiatives and platform optimization
Manage vendor relationships and collaborate with partners to ensure successful project execution
Ensure effective data capture and reporting across medical activities to measure KPIs, metrics, and overall engagement impact
Partner with cross-functional stakeholders across Medical Affairs to ensure technology solutions improve user workflows and enable evolving ways of working
Serve as a key point of contact with enterprise stakeholders, including Commercial Digital and IT teams, to ensure alignment with enterprise-level initiatives
Manage project logistics including planning, timeline development, resource coordination, and budget tracking throughout the project lifecycle

Fulltime

Associate Director, Product Quality Assurance

The Associate Director of Product Quality for Cell and Gene Therapy Programs wil...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in scientific discipline
12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements
Ability to influence without direct authority
Ability to develop into a primary PQL for Beam programs
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Excellent listening, communication and interpersonal skills fostering team spirit

Job Responsibility

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments
Drives and takes action on Phase Appropriate Quality strategy for Beam’s products
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL
Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives
Support clinical to commercial analytical control strategy
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.)
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations

Fulltime

Clinical Scientist Associate Director

In this role, the Clinical Scientist Associate Director supports the design, exe...

Location

Spain

Salary:

90787.65 - 122830.35 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience

Job Responsibility

Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards
Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments
Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring
Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions
Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable
Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites
Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts
Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees
Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies
Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders

Fulltime

Associate Director, Regulatory Affairs

Responsible for global strategic planning of the portfolio within a business uni...

Location

United States , Deerfield

Salary:

176000.00 - 242000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors Degree required, or country equivalent
Masters and/or PhD will be an advantage
Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
Ability to work effectively in multinational/multicultural environment
Management skills
Sound basis of Scientific (Training/ Communications) knowledge
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Established relationships with regulatory authorities

Job Responsibility

Develop and implement regulatory strategy aligned with business strategy
Lead FDA, EU MDR and global submission strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions
Act as primary contact for meetings with the regulatory authorities including the planning and leadership
Implement policies to ensure ongoing compliance with regulatory requirements
May manage regulatory budget at project level
Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms
May represent Baxter interests in industry and working groups

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Director, Regulatory Affairs

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Deerfield, Illinois

Salary:

176000.00 - 242000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors Degree required, or country equivalent
Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
Ability to work effectively in multinational/multicultural environment
Management skills
Sound basis of Scientific (Training/ Communications) knowledge
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Established relationships with regulatory authorities
Demonstrated ability to lead, mentor, and develop others for future growth and development

Job Responsibility

Responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards
Leads, mentors, and develops others in service of Baxter's objectives in alignment with PSS’s hospital bed segment
Participates in strategic LRP and AOP for Hospital Beds
Responsible for all aspects of regulatory strategy for the PSS hospital bed product segment
Provides quarterly regulatory intelligence impact assessments for Batesville, IN site
Oversee Notified Body consolidation activities for the PSS hospital bed group
Lead regulatory efforts for consistent delivery of CCS business objectives
regulatory policy and implementation
and identification and prioritization of key opportunities and risks
Mentors staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, and NPD and sustaining projects

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Associate Director – Employment Tax and Construction Industry Scheme (CIS)

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

Location

United Kingdom , London

Salary:

Not provided

BDO UK LLP

Expiration Date

Until further notice

Requirements

Significant experience advising on CIS across a range of sectors (e.g. property, construction, large corporates, overseas investors)
Strong technical knowledge of: CIS legislation (Finance Act 2004), Contractor vs subcontractor rules, Deemed contractor thresholds and exemptions
Proven track record of dealing with HMRC enquiries, disclosures and technical negotiations
Experience managing complex client relationships and leading engagements
Commercial awareness and ability to translate technical rules into practical advice
An in depth, up to date, knowledge of taxation with specialist knowledge and the ability to deal with complex tax issues beyond CIS (including income taxes, PAYE/NIC, benefits in kind)
Project and staff management experience
Ability to manage a substantial client portfolio profitably whilst being able to actively seek opportunities for developing new clients and for selling new services to existing clients
Experience of dealing with client senior management and success in bids/proposals for new work
Experience in marketing, commoditising new ideas and opportunities

Job Responsibility

Provide expert advice on all aspects of CIS
Advise on complex and high-risk areas
Lead technical input on large and complex client engagements across all aspects of employment taxes, ensuring high-quality, commercially practical advice
Develop your own network of contacts internally and externally and start winning own work and cross selling
Be responsible for coaching and developing junior members of staff
Support clients in meeting their CIS obligations
Advise on remediation of historic compliance issues and implementation of best practice frameworks
Provide guidance on record-keeping and audit readiness
Act as a primary point of contact with HMRC on employment tax and CIS matters
Represent clients in complex discussions with HMRC, ensuring robust technical positions are articulated and defended

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Implementation & Activation Associate Director

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