associate director regulatory affairs

Spyre Therapeutics

<div><div><p>Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (&quot;IBD&quot;) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting &alpha;4&beta;7, TL1A, and IL-23.</p></div><p><b>
Role Summary:</b></p>
<p>
As the Associate Director, Regulatory Affairs (CMC and Devices), you will play a key role in executing CMC and potentially Device regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC and Device regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC and Device-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities.</p>
<p>
You will lead submissions across multiple drug candidates and work closely with Regulatory colleagues, Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents.</p>
<p><b>
Key Responsibilities:</b></p>
<ul>
<li>Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs.</li>
<li>Technical Authoring: Independently author and compile Module 2 and Module 3 content, including quality overall summaries, drug substance, drug product and regional sections, stability summaries, comparability assessments, and supporting technical reports.</li>
<li>Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone.</li>
<li>Device &amp; Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions.</li>
<li>Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression.</li>
<li>Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions.</li>
<li>Other duties as assigned.</li>
</ul>
<p><b>Ideal Candidate:</b></p>
<ul>
<li>Bachelor's degree with a minimum of 6+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience).</li>
<li>Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation.</li>
<li>Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development.</li>
<li>Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations.</li>
<li>Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus.</li>
<li>Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.</li>
<li>Meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment.</li>
<li>Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams.</li>
<li>Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).</li>
</ul>
<p><b>What We Offer:</b></p>
<ul>
<li>Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.</li>
<li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits.</li>
<li>Unlimited PTO</li>
<li>Two, one-week company-wide shutdowns each</li>
<li>Commitment to provide professional development opportunities.</li>
<li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li>
</ul>
<p>The expected salary range offer for this role is $175,000 to $195,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.</p><div><p>
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.</p>
<p>
Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain &quot;@spyre.com.&quot; We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.</p>
<p>
Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</p></div></div>

Associate Director, Regulatory Affairs CMC and Devices

<p></p><div><p><b>Job Description:</b></p><p></p><div><p><b>
Associate Director, Insurance &amp; Risk Management</b></p><p></p><p><b>
Collaborate with Innovative 3Mers Around the World</b></p><p>
Choosing where to start and grow your career has a major impact on your professional and personal life, so it&rsquo;s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a wide variety of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers.</p><p></p><p><b>
This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.</b></p></div><p></p><div><p><b>
The Impact You&rsquo;ll Make in this Role</b></p><p>
As the Associate Director, Insurance &amp; Risk Management, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative people around the world. Here, you will make an impact by:</p><p></p><ul><li>
Executing the organization&rsquo;s global insurance and risk management strategy, ensuring alignment with business objectives and enterprise risk frameworks.</li><li>
Designing, implements, and manages international insurance strategies and programs, including global claims handling and captive insurance company utilization.</li><li>
Own and execute significant insurance programs assigned, including developing renewal strategies and ensuring program structures are fit for purpose and in alignment with budget.</li><li>
Conducting contract reviews and risk and insurance guidance to internal stakeholders.</li><li>
Managing and leading Senior Analyst, Insurance &amp; Risk Management.</li></ul><p></p><p><b>
Your Skills and Expertise</b><br>
</p><p>To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:</p><ul><li>
Bachelor&rsquo;s degree or higher in Finance, Accounting, or Business Administration (completed and verified prior to start).</li><li>
Ten (10) years of professional experience in corporate insurance, risk management, or related fields, with significant exposure to international programs in a private, public, government or military environment.</li></ul><p></p><p>
Additional qualifications that could help you succeed even further in this role include:</p><ul><li>
Strong knowledge of global insurance markets, multinational program structures, and international regulatory environments.</li><li>
Experience managing complex claims across jurisdictions.</li><li>
Proven ability to lead cross-functional initiatives.</li><li>
Exceptional analytical, negotiation, and communication skills.</li><li>
Professional certifications such as CPCU, ARM, CRM or similar accredited industry designations.</li></ul><p></p><p><b>
Work location:</b></p><ul><li><p>
Remote - This position has the possibility for remote work for candidates located more than 50-miles from 3M Global Headquarters in Maplewood, MN. For candidates located within a commutable distance to Maplewood, MN, this role follows an on-site working model, requiring the employee to work at least four days a week at the 3M Center in Maplewood, MN.</p></li></ul><p><b>
Travel: May include up to 10% domestic</b></p><p><b>
Relocation: Is not authorized</b></p><p></p><p><b>
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).</b></p></div><p></p><p><b>
Supporting Your Well-being
</b></p><p>3M offers many programs to help you live your best life &ndash; both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.</p><p></p><p><b>
Chat with Max</b></p><p>
For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers.</p><p></p>
Applicable to US Applicants Only:The expected compensation range for this position is $221,591 - $270,834, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate&rsquo;s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental &amp; Vision, Health Savings Accounts, Health Care &amp; Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.3m.com/3M/en_US/careers-us/working-at-3m/benefits/.<p></p>
All US-based 3M full time employees will need to sign an employee agreement as a condition of employment with 3M. This agreement lays out key terms on using 3M Confidential Information and Trade Secrets. It also has provisions discussing conflicts of interest and how inventions are assigned. Employees that are Job Grade 7 or equivalent and above may also have obligations to not compete against 3M or solicit its employees or customers, both during their employment, and for a period after they leave 3M.<p></p>
Learn more about 3M&rsquo;s creative solutions to the world&rsquo;s problems at www.3M.com or on Instagram, Facebook, and LinkedIn @3M.<p></p>
Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.<p></p>
Safety is a core value at 3M. All employees are expected to contribute to a strong Environmental Health and Safety (EHS) culture by following safety policies, identifying hazards, and engaging in continuous improvement.<p></p>
Pay &amp; Benefits Overview: https://www.3m.com/3M/en_US/careers-us/working-at-3m/benefits/<p></p>
3M does not discriminate in hiring or employment on the basis of race, color, sex, national origin, religion, age, disability, veteran status, or any other characteristic protected by applicable law.<p></p><p><b>
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.</b></p><p></p><p><b>
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Associate Director, Insurance & Risk Management

Electric Power Engineers

<div>Overview:
<div><b>
We are designing the grid of the future!</b><b>
</b></div><div>Electric Power Engineers is seeking an Associate Technical Director of Interconnection Services with a strong background in generation and load interconnection, and transmission planning studies primarily focused on the Western Interconnected system (WECC). In this role, you will work closely with senior leadership to support our growth strategy and provide subject matter expertise both internally through coaching and developing staff, as well as externally to our clients. This role is ideal for a technical expert who thrives on solving hard problems, building trusted relationships, and enjoys mentoring others</div>
Responsibilities:<div></div><div><b><br>
How you can make an impact</b><b>:</b></div><ul><li>
Lead and perform complex <b>load and generation interconnection studies</b> in accordance with ISO and utility methodologies.</li><li>
Oversee and execute <b>model benchmarking</b> for generation and load projects, ensuring compliance with existing and emerging requirements.</li><li>
Serve as a subject matter expert on interconnection studies, staying current with regulatory changes and industry trends.</li><li>
Strengthen delivery frameworks, QA/QC processes, and technical standards to ensure high-quality, efficient project execution.</li><li>
Mentor and develop a small team of engineers by coaching both technical depth and client-facing excellence, and fostering a culture of ownership, accountability, and innovation.</li><li>
Represent the firm in industry forums, conferences, and technical publications.</li></ul><div><b>
Client &amp; Market Leadership</b></div><ul><li>
Act as a trusted advisor to generation, large load, and merchant transmission developers navigating the evolving interconnection landscape in the Western Electricity Coordinating Council (WECC)).</li><li>
Lead technical reviews of interconnection studies&mdash;replicating results, identifying risks, and developing creative strategies to reduce upgrade costs and accelerate timelines.</li><li>
Translate complex technical findings into clear, actionable recommendations that drive informed commercial decisions.</li><li>
Collaborate with senior leadership to develop new tools, services, and go-to-market strategies.</li><li>
Support RFP responses and scope development with strong technical and commercial alignment.</li></ul>
Qualifications:
<div><b>
Bring your passion, here's what&rsquo;s needed:</b></div><ul><li>
8+ years of experience in the electric energy industry.</li><li>
Direct experience with CAISO and the WECC Interconnected System, a utility within their footprint, or consulting on their behalf.</li><li>
Hands-on experience in multiple study types, such as:</li><li><ul><li>
Injection and Deliverability studies</li><li>
PSLF/PSCAD benchmarking</li><li>
Transitional Cluster studies in WECC</li><li>
Load interconnection studies replicating ISO/utility practices</li></ul></li><li>
Experience in IBR modeling, load modeling, generation/load interconnection studies, transmission planning, and/or EMT studies.</li><li>
Strong command of ISO and utility interconnection standards in WECC. .</li><li>
Proficiency in several of the following: <b>PSLF, PSSE, TARA, PSCAD, and ASPEN, </b>.</li><li>
Ability to connect technical rigor with commercial strategy.</li><li>
Exceptional communication skills and confidence in making decisions under uncertainty.</li><li>
Proven ability to work independently and collaboratively across cross-functional teams.</li></ul><div></div><div><b><br>
Beneficial Experience</b></div><ul><li>
Experience with EMT (ideally PSCAD) modeling/studies</li><li>
Experience performing interconnection or transmission planning studies outside the Northeast</li><li>
Automation experience (Python, C#, SQL)</li></ul><div></div><div><b><br>
Lead the Change!</b></div><div>
Be a part of an innovative team shaping the grid of the future through advanced energy intelligence. For more than half a century, Electric Power Engineers (EPE) has partnered with power and energy clients across the globe, providing consulting expertise and energy intelligence software solutions for complex engineering and grid modeling challenges. As leaders in the renewables space, we are focused on building a modern, secure, and resilient grid. Join us in making an impact on the communities we serve and the environment in which we live. Together we can transform the future of energy.</div><div></div><div><b><br>
How we support you:</b></div><ul><li>
Comprehensive health and wellness benefits including medical, dental, and vision with 100% premium coverage for you</li><li>
Generous PTO and paid holidays</li><li>
MyShare Employee Ownership Program</li><li>
Work with industry leaders</li><li>
401K, up to a 4% match (100% vested from day 1)</li></ul><div></div><div><b><i><br>
Location</i></b>: This position will be open to remote US or Canada</div><div><b><i>
Travel</i></b>: Occasional travel may be needed (10% or less)</div><div></div><div><i><br>
EPE is an equal opportunity/AA/Disability/Veteran employer. The EEO is the Law poster, and its supplement are available using the following links: </i><i>EEOC is the Law Poster</i></div><div></div><div><b><i><br>
Third-Party Recruiting Notification</i></b></div><p><i>
EPE does not accept unsolicited resumes from </i><b><i>third-party recruiters</i></b><i>. Any unsolicited third-party resumes forwarded by recruiters to EPE via our career page or to any of our managers or employees will be considered public information, may be treated as a direct application from the person identified in the resume, and will not be eligible for placement fee payment to the agency. EPE will not pay a fee to a third-party recruiter or agency</i> without a previously signed third-party agreement<i> and has not coordinated their recruiting activity with the appropriate member of the Talent Acquisition team.</i></p><div>
#LI-RT1</div></div>

Associate Director - WECC Interconnection

Gleeds

<div><div><div><div><ul><div><div><div><div><div><div>Careers Site Advertising End Date</div></div></div></div><div>
07 Jun 2026</div>
</div></div><div><div><div><div><div><div>Internal Advertising End Date</div></div></div></div><div>
07 Jun 2026</div>
</div></div><div><div><div><div><div><div>All Locations</div></div></div></div><div>
<div>Riyadh
</div></div></div></div><div><div><div><div><div><div>Sector</div></div></div></div><div>
Real Estate &amp; Property</div></div></div></ul></div></div></div></div><div></div>
<br><div></div><div><div><ul><div><div><div><div><p><b>About this opportunity</b></p>
<div>
<ul><li><b>Associate Director</b></li>
<li><b>Pre contract Quantity Surveying services</b></li>
<li><b>Riyadh, Saudi Arabia</b></li>
<li><b>Buildings &amp; Real Estate construction</b></li>
</ul>
</div><p>Gleeds in the Kingdom of Saudi Arabia has an exciting career opportunity, supporting a number of iconic programs across the Kingdom. We are seeking a pre contract specialist MRICS qualified Quantity Surveying professional with a real passion for pre contract services, who wants to develop their career in a personable and professional environment.</p>
<div><b>
Key Responsibilities</b></div>
<div>
<p>Responsibilities include but are not limited to:</p>
<ul>
<li>Delivering pre contract cost management services from concept design through detailed design</li>
<li>Managing commissions to deliver high quality services and deliverables in accordance with the Gleeds procedures.</li>
<li>Positively engaging with Clients and developing, growing and maintaining Client relationships</li>
<li>Cost Planning, Estimating</li>
<li>Value Engineering</li>
<li>Bills of Quantities</li>
<li>Advising on and implementing procurement strategies.</li>
<li>Preparing tender documentation and managing the tender process, including designing tender marking schemes.</li>
<li>Producing and presenting reports to Clients.</li>
<li>Advising Directors promptly of any issues that have arisen, or that might arise, on projects</li>
</ul>
</div></div></div></div></div><div></div><div><div><div><div><p><b>Who we&rsquo;re looking for:</b></p>
<p><b>
Experience, Knowledge and Key Skills</b></p>
<div>
<div><ul><li>MRICS Chartered</li>
<li>Expert knowledge and practical experience of pre contract cost management</li>
<li>15+ years post graduate experience in all aspects of quantity surveying</li>
<li>3+ years&rsquo; experience in Saudi Arabia</li>
<li>3+ years&rsquo; experience with a top QS consultancy organisation</li>
<li>Experience of building projects and major mixed use developments</li>
<li>Practical knowledge of construction procurement strategies, including tendering and contract strategies.</li>
<li>Clear and effective communication skills - both oral and written</li>
</ul>
</div><p><b>Qualifications</b></p>
</div>
<div><ul><li>Degree in Quantity Surveying</li>
<li>MRICS or equivalent chartered status
</li><li>Native English level written and oral skills</li>
<li>Arabic desirable</li>
<li>Transferable Iqama</li></ul></div><br>
<div>
</div></div></div></div></div><p></p><div><div><div><div><p><b>Be part of the extraordinary</b></p>
<p>
Every day at Gleeds, we influence the way people around the world live, work and travel. Delivering on the world&rsquo;s most iconic projects for globally renowned clients, our teams solve complex problems that shape the future of the built environment.</p>
<p>
One of the qualities we value in people, is the ability to think creatively about the solutions we offer to clients. With over 80 offices spanning the Americas, Europe, MENA and Asia Pacific our ability to innovate and improve is a product of the varied backgrounds and experience of our people. We welcome new perspectives and ideas.</p>
<p>
Above all, we believe that quality relationships sit at the heart of good business. We strive to be the people that seek to understand and bring people together. Wherever we are in the world, our aspiration is to leave a positive legacy for people and local communities, whilst living and breathing our three core values:</p>
<ul>
<li>We&rsquo;re committed to our clients and our people</li>
<li>We&rsquo;re creative and realistic</li>
<li>We combine professionalism with personality</li>
</ul><div><div>#LI-JS1</div>
<div> #LI-Onsite</div></div></div></div></div></div></ul></div></div><p></p>

Associate Director MRICS

<div><div><div><div><ul><div><div><div><div><div><div>Careers Site Advertising End Date</div></div></div></div><div>
07 Jun 2026</div>
</div></div><div><div><div><div><div><div>All Locations</div></div></div></div><div>
<div>Doha
</div></div></div></div><div><div><div><div><div><div>Sector</div></div></div></div><div>
Real Estate &amp; Property</div></div></div></ul></div></div></div></div><div></div>
<br><div></div><div><div><ul><div><div><div><div><p><b>About this opportunity</b></p>
<div>
<ul><li><b>Associate Director / Team Leader Cost Management</b></li>
<li><b>Pre &amp; post contract Quantity Surveying services</b></li>
<li><b>Doha, Qatar</b></li>
<li><b>Buildings &amp; Real Estate operations and maintenance</b></li>
</ul>
</div><p>Construct a career with purpose! Gleeds in Qatar has an exciting career opportunity, providing cost management services for construction and facilities management packages for a major development in Doha, Qatar. We are seeking a MRICS qualified Quantity Surveying professional with great team leadership skills, who wants to develop their career in a personable and professional environment.</p>
<div><b>
Key Responsibilities</b></div>
<div>
<p>Responsibilities include but are not limited to:</p>
<ul>
<li>Delivering pre &amp; post contract cost management services for construction and FM Packages</li>
<li>Advising on and implementing facilities management procurement strategies.</li>
<li>Managing commissions to deliver high quality services and deliverables in accordance with the Gleeds procedures.</li>
<li>Positively engaging with Clients and developing, growing and maintaining Client relationships</li>
<li>A senior member of the CONSULTANT organisation who has the authority to act on Gleeds behalf at meetings with the client Senior management as and when required</li>
<li>Cost Planning, Estimating</li>
<li>Value Engineering</li>
<li>Bills of Quantities</li>
<li>Preparing tender documentation and managing the tender process, including designing tender marking schemes.</li>
<li>Producing and presenting reports to Clients.</li>
<li>Advising Directors promptly of any issues that have arisen, or that might arise, on projects</li>
</ul>
</div></div></div></div></div><div></div><div><div><div><div><p><b>Who we&rsquo;re looking for:</b></p>
<p><b>
Experience, Knowledge and Key Skills</b></p>
<div>
<div><ul><li>MRICS Chartered</li>
<li>MMUP Grade A</li>
<li>Expert knowledge and practical experience of pre and post contract cost management</li>
<li>15+ years post graduate experience in all aspects of quantity surveying</li>
<li>10+ years&rsquo; experience in GCC, including Qatar</li>
<li>5+ years&rsquo; experience on an infrastructure project in excess of US$100m</li>
<li>Experience of building projects and major mixed use developments</li>
<li>Practical knowledge of construction procurement strategies, including tendering and contract strategies.</li>
<li>Clear and effective communication skills - both oral and written</li>
</ul>
</div><p><b>Qualifications</b></p>
</div>
<div><ul><li>Degree in Quantity Surveying or an appropriate degree in engineering</li>
<li>MRICS or equivalent chartered status</li>
<li>MMUP Grade A</li>
<li>Fluent English written and verbal skills</li></ul></div><br>
<div>
</div></div></div></div></div><p></p><div><div><div><div><p><b>Be part of the extraordinary</b></p>
<p>
Every day at Gleeds, we influence the way people around the world live, work and travel. Delivering on the world&rsquo;s most iconic projects for globally renowned clients, our teams solve complex problems that shape the future of the built environment.</p>
<p>
One of the qualities we value in people, is the ability to think creatively about the solutions we offer to clients. With over 80 offices spanning the Americas, Europe, MENA and Asia Pacific our ability to innovate and improve is a product of the varied backgrounds and experience of our people. We welcome new perspectives and ideas.</p>
<p>
Above all, we believe that quality relationships sit at the heart of good business. We strive to be the people that seek to understand and bring people together. Wherever we are in the world, our aspiration is to leave a positive legacy for people and local communities, whilst living and breathing our three core values:</p>
<ul>
<li>We&rsquo;re committed to our clients and our people</li>
<li>We&rsquo;re creative and realistic</li>
<li>We combine professionalism with personality</li>
</ul><div><div>#LI-JS1</div>
<div> #LI-Onsite</div></div></div></div></div></div></ul></div></div><p></p>

IQVIA

<div>Istanbul, Turkey | Full time | Home-based | R1535388</div>
<br><div><div>To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</div><div>
Responsabilities:</div><ul><li>
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.</li><li>
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies</li><li>
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.</li><li>
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.</li><li>
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.</li><li>
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.</li><li>
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.</li><li>
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.</li><li>
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.</li><li>
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.</li><li>
Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).</li><li>
Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.</li><li>
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.</li><li>
Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.</li><li>
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.</li><li>
Proactively identifies risks and facilitates resolution of complex study problems and issues.</li><li>
Organises regular Local Study Team meetings on an agenda driven basis.</li><li>
Actively works towards achieving good personal relationships with all Local Study Team members, sites&rsquo; staff and global stakeholders.</li><li>
Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.</li><li>
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.</li><li>
Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.</li><li>
Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.</li><li>
Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.</li><li>
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.</li><li>
Provides input to process development and improvement.</li><li>
Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.</li><li>
Updates Line Managers about the performance of the CRAs/CSAs.</li><li>
Ensures that study activities at country level comply with local policies and code of ethics.</li><li>
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.</li><li>
Ensures compliance with Sponsor&acute;s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).</li><li>
Collaborates with local Medical Affairs team.</li><li>
Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.</li></ul><div>
Requirements:</div><ul><li>
Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).</li><li>
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).</li><li>
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.</li><li>
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.</li><li>
Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas</li><li>
Good knowledge of the Drug Development Process.</li><li>
Excellent understanding of the Clinical Study Process including monitoring.</li><li>
Very good understanding of the Study Drug Handling Process and the Data Management Process.</li><li>
Excellent project management skills.</li><li>
Excellent team building and interpersonal skills, organizational skill and verbal and written communication skills</li><li>
Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.</li><li>
Excellent knowledge of spoken and written English and local languages.</li><li>
Good ability to learn and to adapt to work with IT systems.</li><li>
Ability to travel nationally and internationally as required</li></ul><div><i>
&quot;Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered&rdquo;.</i></div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div>

Local Study Associate Director - Sponsor Dedicated (m/w/d)

Champion Petfoods

<p></p><div><p><b>Job Description:
</b></p><p>Champion Petfoods is expanding! We are excited to announce we are looking for a Corporate Communications Manager to join our rapidly growing company.
</p><p>Champion Petfoods is an award-winning pet food maker with a reputation of trust spanning 35+ years. Founded in a small town in Alberta, Canada, Champion &ndash; with its ORIJEN&reg; and ACANA&reg; brands &ndash; is a key player in the global premium pet food industry across three major geographic regions.
</p><p>We would love to hear from you if you are passionate about personal and professional growth and see yourself as a key player contributing to our continued success as an award-winning company.
</p><p></p><p><b>Summary:
</b></p><p>The Corporate Communications Manager is a foundational role on the Champion Petfoods Corporate Affairs team. Reporting to the Senior Director of Corporate Affairs, you will be a key player supporting both the Director of Internal Communications and the Director of External Communications.
</p><p></p><p>This is a hands-on role focused on the execution of communications tactics that bring our strategies to life, engage our Associates and help build our corporate reputation.
</p><p></p><p>You will draft content for a variety of channels, coordinate key projects, assist with media relations and events and play a vital part in the day-to-day success of the Corporate Affairs team.
</p><p></p><p>This position works on a hybrid schedule with 3 days in-person at our Flatirons office in Boulder, Colorado and reports to the Senior Director, Corporate Affairs.
</p><p></p><p><b>Key Responsibilities:
</b></p><p></p><p><b>Internal Communications Support
</b></p><ul><li>Draft and publish clear and compelling content for our internal channels, including announcements, newsletters and intranet stories.
</li><li>Assist in the preparation of materials for all-Associate town halls, leadership meetings and other internal events.
</li><li>Support the activation of the Mars Signature Programs, such as Mars Volunteer Program and other community engagement initiatives. Help to coordinate logistics and promote events to Associates.
</li><li>Help manage the internal communications calendar and assist with channel performance measurement.
</li></ul><p></p><p><b>External Communications Support
</b></p><ul><li>Assist in the execution of external communications campaigns by drafting press releases, pitches and other media materials.
</li><li>Provide support as needed for brand PR activities for Champion brands ORIJEN&trade; and ACANA&trade;.
</li><li>Support media relations by maintaining media lists, tracking coverage and assisting with the creation of monitoring reports that go to Champion senior leaders.
</li><li>Provide tactical support for our PR agency partners, helping to coordinate requests and manage project timelines.
</li><li>Execute the content strategy for our corporate social media channels, including drafting and posting content for LinkedIn.
</li><li>Assist in coordinating the logistics of product donations and support relationships with local community partners.
</li></ul><p></p><p><b>Corporate Affairs Team Support
</b></p><ul><li>Provide project management support to the Corporate Affairs Directors, helping to coordinate with regional and market contacts and track deliverables.
</li><li>Help maintain the library of foundational communications assets, including messaging, photos and reactive statements.
</li><li>Help create and manage a Champion Corporate Affairs Portal for Champion Associates.
</li><li>Work with the global Pet Nutrition Corporate Affairs team members to ensure Champion internal and external activities are reflected in the global Petcare communications calendar.
</li><li>Act as a collaborative and proactive partner to the entire Corporate Affairs team, assisting with administrative and project-based needs as they arise.
</li></ul><p></p><p><b>Key Requirements:
</b></p><ul><li>Bachelor&rsquo;s degree in communications, journalism, marketing or a related field.
</li><li>5+ years of professional experience in a communications or public relations role, either in-house or at an agency.
</li><li>In-house or PR agency industry experience in CPG or manufacturing is a plus.
</li><li>Exceptional writing, editing, and proofreading skills, with a high level of attention to detail.
</li><li>Proven ability to manage multiple projects and meet deadlines in a fast-paced environment.
</li><li>Experience with both internal and external communications tactics.
</li><li>Familiarity with communications tools and platforms (e.g., media monitoring services, social media schedulers, email or intranet platforms).
</li><li>A collaborative, team-oriented mindset with a strong willingness to learn and grow.
</li><li>Ability to work independently on assigned tasks and projects.
</li></ul><p></p><p><b>Mars Leadership Competencies
</b></p><ul><li>Action Oriented
</li><li>Drives Results
</li><li>Self-Development
</li><li>Collaborates
</li><li>Communicates Effectively
</li></ul><p></p><p><b>Functional Competencies &amp; Technical Skills
</b></p><ul><li>Writing and Editing
</li><li>Storytelling
</li><li>Content Development (long-form, digital channels, social media)
</li><li>Media Relations
</li><li>Associate &amp; Leadership Communications
</li><li>Digital Fluency, including leveraging AI to support communications
</li><li>Working with agencies and cross-functional teams
</li></ul><p></p><p><b>What can you expect from Champion?
</b></p><ul><li><b>Safety: </b>a strong commitment to ensure all people are provided with a safe, healthy and respectful environment.
</li><li><b>Earnings: </b>Salary range from $79,000 - $90,000 USD, 401k with donation matching.
</li><li><b>Industry Competitive Benefits: </b>Medical, Dental, Vision and Employee Assistance Programs to meet your individual or family needs.
</li><li><b>Continuing Education: </b>In House &amp; Online Learning &amp; Development, as well as an Education Assistance Program.
</li><li><b>Quality: </b>a dedication to uphold the highest standards of authenticity, nutritional integrity, and food safety, to earn the trust of Pet Lovers everywhere.
</li><li><b>Other Perks: </b>Free Bag of Premium Pet Food each month, Free Parking and more!
</li></ul><p></p><p>What are you waiting for? Join the pack!
</p><p></p><p><b>Come as you are.
</b></p><p>We value diversity in all forms and know the power it can bring. Workplace equality allows for creative ideas to bloom, diverse points of views to be heard, and increases overall happiness. That sounds pretty good to us.
</p><p>Champion is an equal opportunity employer. Regardless of your race, color, religion, sex, national origin, sexual orientation, gender identity, disability, age, veteran status, or any other creed, you are wanted here.
</p><p>#cpfind
</p><p></p><p>The base pay range for this position at commencement of employment is expected to be between the range listed above, however, base pay offered may vary depending on multiple individualized factors, including but not limited to, market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, if eligible, including variable pay, medical and dental benefits, participation in 401k plan, and paid time off benefits. Eligibility for these additional elements depend on the position offered and the employee&rsquo;s work schedule (i.e., part-time schedule, store associate). Details of participation in these benefit plans will be provided if an applicant receives an offer of employment.</p></div>

Corporate Communications Manager

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Local Study Associate Director - Sponsor Dedicated (m/w/d)

Corporate Communications Manager