Veranova Pharma Jobs in Usa

Astek is strengthening its teams of QA Specialists.

Description :

Quality Assurance for Clinical Supply & Cold Chain, supporting the review and approval of GDP documentation generated in the context of supplying products for clinical studies.

Main tasks :

• Review of Supply Flow in line with clinical logistics strategy and qualified status of providers used
• Review of feasibility analysis of transfers between commercial sites, technical research and development GMP department, and its CMOs or between clinical sites to ensure quality attributes of products received and compliance of providers used
• Generation and/or review of cold chain documentation provided to CMOs/CROs to confirm storage conditions and cold chain budget allocated to CMO/CRO activities
• Determination of the cold chain budget available at the time of Release of batches prior to shipment to clinical sites
• Assessment of temperature excursions during storage or distribution of products for clinical studies

Required skills :

• 3 to 5 years of experience in a Quality Assurance environment; ideally in the pharma industry
• Knowledge of cGMP, GDP, cold chain, manufacturing operations, clinical trial, product development and regulatory requirements
• Need of a good scientific background to understand the objectives of the studies and to interact with both GMP & Clinical operations
• Understanding of how clinical trials are set up and run as well as the associated legal and regulatory framework
• Good communication skills: ability to listen effectively, communicate complex matters both verbally and in writing, and ask questions that lead to the discovery of root causes
• Master's degree in Sciences/Engineering/Bioengineering

We are partnered with a pharmaceutical company near the Carmel, IN area who is looking for a Quality Control Lab Technician.

We are open to backgrounds in food, pharma, chemical, R&D, etc.

• Perform routine laboratory testing on raw materials, in-process samples, and finished pharmaceutical products following approved methods and standard operating procedures (SOPs)
• Accurately document test results in laboratory notebooks and electronic systems in compliance with GMP (Good Manufacturing Practices) and data integrity standards
• Assist in the calibration, maintenance, and troubleshooting of laboratory instruments and equipment
• Prepare reagents, solutions, and samples according to specified procedures
• Review and verify data for accuracy, completeness, and compliance with regulatory requirements
• Support investigations of out-of-specification (OOS) results and deviations
• Maintain a clean, organized, and safe laboratory environment in accordance with company policies and safety regulations
• Collaborate with cross-functional teams including manufacturing, quality assurance, and research & development

Thank you!

Aegis Worldwide

Clinical Trial Associate - HYBRID in Wilmington, DE

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

What You Will Be Doing:

• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.

Your Profile:

• Industry experience in clinical trial support required (CRO/Pharma)
• BS/BA degree required
• Experience with vendor management, strong verbal & written communication skills,
• and strong organizational skills
• Previous administrative experience
• Proven organizational and administrative skills
• Computer proficiency
• Display excellent organization and time management skills, excellent attention to
• detail, and ability to multi-task in a high-volume environment with shifting priorities
• Team oriented and flexible; ability to respond quickly to shifting demands and
• opportunities
• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to study Start-up, together with an understanding of the ICH/GCP guidelines
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Good interpersonal skills and ability to work in an international team environment
• Willingness and ability to train others on study administration procedures
• Integrity and high ethical standards
• eTMF experience in Veeva required
• Must be comfortable with a home/office-based hybrid role in Wilmington DE.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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 Program, TELUS Health, 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

Location: Upstate NY (Relocation from Canada welcome!)

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Full-Time | Onsite

About the Role:

We’re looking for a detail-driven HEPA Certification Coordinator to manage and maintain HEPA filter compliance across our pharmaceutical cleanroom facilities. You’ll work with internal teams and external vendors to ensure air quality standards are met and documented.

What You’ll Do:

• Oversee HEPA filter certification and scheduling
• Ensure compliance with GxP and industry standards
• Coordinate with vendors and internal teams
• Maintain accurate documentation and reports
• Support investigations and continuous improvement

What You Bring:

• 3+ years in pharma manufacturing with cleanroom experience
• Knowledge of HEPA standards, GxP
• Strong communication and organizational skills
• Bachelor’s in engineering, Science, or related field

Perks & Benefits:

• Competitive salary
• Full health, dental, vision, and retirement benefits
• Tuition reimbursement, PTO, and more

Ready to make an impact? Apply now and help us maintain the highest standards in cleanroom air quality.

Job Title: Compliance Specialist II

Location: Northborough, MA(01532)

Duration: 12 Months(Possibility of extension)

Shift: 1st Work Schedule: M-F 8am-5pm (OT possible and weekends if needed)

Job Description:

Main Accountabilities- Ensuring that activities within scope are conducted in compliance with applicable regulatory requirements

Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations

Perform finished product inspections according to standards, specifications established timelines

Perform AQL inspections according to standards, specifications established timelines

Trend AQL failures according to standards, specifications established timelines

Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelines

Manage / perform annual inspection of retention samples

Support creation of new material and product specifications

Perform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines

Support department Quality Management System (Change Control, Deviations, CAPA)

Support department documentation archival system

Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor

Managing / escalating and resolving quality-related issues in a timely and effective manner

Support the monitoring and analyzing of quality performance metrics, implementing corrective actions as needed

Support root cause analysis investigations for quality incidents and implementing preventive measures

Support quality walkthroughs

Participating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focus

Support risk management strategies to mitigate potential quality issues

Fostering a culture of quality and continuous improvement across the organization

Key Roles- Request corrections when GMP rules are not respected

Prioritize quality and compliance objectives

Request quality improvement initiatives and strategies

Identify discrepancies and corrective/preventive actions that need to be taken

Escalate to upper management any failure in GMP execution on shopfloor

Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures

Advise on how to present a topic and answer specific questions

Advise on risk management strategies and plans

Advise on initiatives to promote a quality-focused culture

Minimum 3 years of related experience

Minimum Education: Bachelors degree

Must have Skills:

• Bachelors degree (Masters and PHD's will be accepted)

• 3 Year experience in related role (more experience the better)

• Quality Shop floor experience, quality assurance review experience

• Experience with inspecting finished goods and product

• Previous pharma and biotech experience / GMP (strongly preferred)

Nice to have

• Change Control, Deviations, CAPA (strongly preferred)

• SAP, Veeva

Ready to shape the future of work?

At Genpact, we do not just adapt to change—we drive it. AI and digital innovation are redefining industries, and we are leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges.

If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that is shaping the future, this is your moment.

Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implementdata, technology, and AI to create tomorrow, today. Get to know us at and on LinkedIn, X, YouTube, and Facebook.

Inviting applications for the role of Senior Manager, Commercial/ Payer Analytics with Market access experience

We are seeking seasoned Senior Manager Experience in pharmaceutical and life sciences analytics, with proven expertise in Anonymous Patient-Level Data (APLD),Xponent, Plantrak & formulary access data. This leadership role demands a balance of strategic vision, deep technical acumen, and cross-functional influence. The ideal candidate will drive advanced analytics initiatives that support marketing and commercial excellence strategies, while leading global delivery teams and shaping stakeholder alignment across business units.

Responsibilities

• Lead strategic analytics initiatives across pharmaceutical, Value & Access, and healthcare payer/provider domains.
• Apply machine learning techniques to structured and unstructured data to enhance patient stratification, drive Sales and health outcomes.
• Develop analytical and statistical solutions to improve efficiency and drive innovations using Generative AI.
• Lead the development of U.S. market access strategies across therapeutic areas including formulary positioning, pricing, and reimbursement.
• Partner with global teams to align value messaging with regional payer and RAE/KAM expectations.
• Conduct and interpret advanced analytics to support decision-making on promotional strategies and effectiveness (e.g., ROI, A/B testing, campaign performance).
• Lead the Health System engagement by generating valuable insights for RAE/KAM teams.
• Able to handle complex statistical analysis to measure the effectiveness of certain campaigns and help in monitoring VCOs/KAM/NAD/NAM performance.
• Data Analysis: Leverage data analytics tools to analyze market trends, track sales performance, and provide actionable insights to sales teams.
• Design and execute test-control methodologies and statistical procedures to evaluate marketing campaign success.
• Lead predictive analytics projects including segmentation, profiling, and targeting strategies.
• Functionally and directionally lead an offshore analytics team while maintaining individual contributor responsibilities.
• Act as a strategic consultant to stakeholders, translating business needs into analytical solutions and actionable insights.
• Collaborate with data engineering and source data teams to address data quality and timing issues.

Qualifications we seek in you!

• Bachelors in Pharma/Technology/BE.
• Experience in U.S. healthcare analytics, including pharmaceuticals, biotech, or payer/provider systems.
• Machine learning and statistical modeling knowledge (e.g., XGBoost, Random Forest, NLP, deep learning).
• Knowledge on GenAI.
• Proficient in Python, SQL.
• Strong knowledge of U.S. healthcare datasets: Medicare/Medicaid, commercial claims, EMR systems, Sales & Commercial data sets in healthcare etc.
• Solid grasp of healthcare economics, policy frameworks, and regulatory constraints.

Preferred Qualifications/ Skills

• Knowledge of Spark, and data visualization tools (Power BI, Tableau) and R is preferred.
• M.Sc./M.Tech./M.Pharm
• Excellent MS Office Skills.
• Strong analytical, problem-solving skills, and technical aptitude.
• Expert verbal and written communication skills.
• High degree of energy & execution and client connect experience is a “Must”.
• Ability to work in a global environment.
• Proven work experience as a team leader or supervisor.
• Good analytical and problem-solving skills.
• Good accounting concepts.
• Good interpersonal skills.

Why join Genpact?

• Be a transformation leader – Work at the cutting edge of AI, automation, and digital innovation.
• Make an impact – Drive change for global enterprises and solve business challenges that matter.
• Accelerate your career – Get hands-on experience, mentorship, and continuous learning opportunities.
• Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day.
• Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress.

Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.

Let us build tomorrow together.

The approximate annual base compensation range for this position is $150,000 to $160,000. The actual offer, reflecting the total compensation package plus benefits, will be determined by a number of factors which include but are not limited to the applicant’s experience, knowledge, skills, and abilities; geographic location; and internal equity.

Location-based Roles Danbury, CT area candidates are eligible for this role only.”

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

Senior Scientist

Kelly Science and Clinical, is currently seeking a Senior Scientist (Protein Mass Spectrometry) for a long-term engagement at one of our Global pharma clients in Spring House, PA. This role is a fully benefitted position. This role you will be eligible for Medical, Dental, 401K, paid time off, including holiday, vacation and sick/personal time.

Schedule: On-site Monday through Friday 8am to 5pm

Length of assignment: Until the end of 2026 will likely to extend

Pay: $45-50 an hour Depending on experience

You will be required to provide your own laptop

• Responsibilities:Intact protein mass analysis using LC/MS platforms- QC analysis and high throughput analysis for biologics (mAbs, multispecifics antibodies, Fabs, scFv, fusion proteins)
• Data analysis, documentation, and reporting – ELNs, etc.
• Lab instrument maintenance – General ESI source cleaning and routine calibration
• Prepare HPLC solvents and replenish as needed
• Prepare general buffers and reagents for enzymatic digestions and assays etc
• MS Lab-specific supply maintenance – inventory and ordering
• Chemical inventory for EHS
• Additional Duties:
• Support assay development and validation as needed.
• Assist in drafting and executing peer-reviewed posters, manuscripts, tech reports, and patent filings.
• Attend in-house seminars to support team goals.
• Requirements: Experience with mass spectrometry is required.
• Previous experience handling and working with proteins using general protein biochemistry techniques including but not limited to aliquoting and pipetting is required.
• Pharmaceutical experience working with antibodies is preferred.
• Experience with automated liquid handlers is preferred. Pharmaceutical experience working with antibodies is preferred.
• Candidate must be highly organized, independent, and very detail oriented.
• Education requirements: Ph.D. with 0-2 years’ experience, or MS with 3-5 years’ experience, or a B.S. with 10+ years in an analytical chemistry discipline

What happens next

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what’s next in your career is what we’re all about,

#P1

#2611 Business Development Manager

Our client is a global pharmaceutical contract development and manufacturing service provider. Offering services from discovery to commercialization for both drug substances and drug products.

The Business Development Manager is to identify and secure new accounts(pharma/biotech/med device) for the company. Additionally, the person in this role will leverage existing customer relationships to penetrate customer locations that are not currently doing business with. This position will report to the General Manager.

Responsibilities:

• Pursue business opportunities for the services offered via prospecting, building strong client relationships, forging new business partnerships, nurturing and qualifying leads, and maintaining high visibility within networking and trade organizations within the defined territory.
• Identify industry and customer needs and actively provide solutions that will generate value for the customer.
• Represent company at events to generate leads and gather market intelligence.
• Remain integral to the ongoing relationships between groups internal to the external customer.
• Lead the initiative to introduce new projects and business opportunities pursuant to overall business strategy both at existing and new accounts.
• Collaborate with Marketing for effective lead generation to support Sales targets.
• Promptly and completely capture information associated with leads and opportunities in .
• Assist new customers and prospects using scripts to ask relevant questions, capturing the responses in , for accurate and timely quote generation and a seamless handoff to Operations
• Continuously develop expertise regarding the site’s services and industry trends.

Qualifications:

• Minimum of a bachelor’s degree in physical or life sciences is required.
• A minimum of 3 years’ experience in business development, with proven track record in selling microbiological, environmental monitoring and analytical services.

About the Company:

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.

Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

POSITION SUMMARY

The Key Account Director (KAD) Sales - Oncology is responsible for the strategic engagement with Integrated Delivery Systems (IDNs), health systems, large group practices and high-volume HCPs to drive the launching, adoption and selling of the assigned portfolio of Celltrion USA, Inc. (“Company). This role is pivotal in executing market access strategies, fostering provider relationships, and ensuring successful product launches within the assigned territory. Other responsibility includes analysis of sales data to identify opportunities for business growth in assigned territory.

Territorial assignment is ORLANDO, FLORIDA.

KEY ROLES AND RESPONSIBILITIES

Strategic Planning and Execution- Deliverplans and achieve sales goals on budget.

• Develop and implement comprehensive business plans tailored to key accounts and align with national objectives/local market dynamics.
• Identify and prioritize opportunities within IDNs and large health systems to maximize biosimilar uptake.
• Identify opportunities and strategies to improve the positioning of Celltrion USA products at a local level.

Stakeholder Engagement

• Establish and maintain relationships with key decision-makers, including formulary committees, pharmacy directors and clinical leaders.
• Collaborate with cross-functional teams (e.g. Medical Affairs, Market Access, Marketing) to deliver cohesive value propositions.

Collaborate with Market Access & Contracting

• With Market Access, engage in negotiations and manage contracts within key accounts to ensure favorable terms that support adoption
• Monitor and address reimbursement challenges working closely with internal teams
• Engage HCPs in dialogue about approved indications, product efficacy/safety profiles, and treatment protocols to support on-label prescribing for appropriate patients.

Data Analysis and Reporting

• Analyze trends, competitive landscape and account performance
• Provide regular reports on key account metrics
• Collaborate with field salesforce as needed for pull-through

WORK EXPERIENCE

Minimum of 10 years of experience in Pharma-Commercial, pre-launch launch, and post-launch of products.

QUALIFICATIONS

• Extensive knowledge and experience in biologics, biosimilars, and the full life cycle of product launch and post-launch.
• Solid business acumen, including the ability to access and interpret company provided territory data to incorporate into call planning and execution.
• Both a team player and individual contributor.
• Demonstrated excellent interpersonal, written, verbal, and visual communication and presentation skills.
• Ability to handle multiple tasks and prioritize accordingly by directing the team effectively.
• Ability to travel 50% of the time

EDUCATION

Bachelor’s Degree required in business or related field; advanced degrees, MBA, MS in business or related field is a plus.

CORE COMPETENCIES

• Communication - clear, concise, and ability to motivate; ability to articulate about the company and products
• Knowledge - understanding of product portfolio
• Collaboration - ability to communicate across functions and at all levels in the organization
• Compliance – understands industry regulations to maintain compliance
• Nimbleness – an ability to be adaptive and responsive to changing conditions in order to seize opportunities and overcome challenges.

Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

#LI-MDR-D

TOP SKILLS PER MGR:

1. Pharma Industry Experience

2. Experience w/GxP documentation required (not GMP)

3. SOP Writing expertise

4. Patient Safety knowledge/experience (HUGE PLUS)

Job Summary:

We are seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement within the Technical Writing Group. This role will emphasize the development of procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also producing training materials and job aids.

Key Responsibilities:

- Lead a multidisciplinary team of subject matter experts, business process owners, and key stakeholders in the development, revision, enhancement, implementation, and maintenance of process and procedural documentation.

- Plan and manage multiple process development projects simultaneously, ensuring timely delivery of targeted outcomes.

- Create and write content for training programs, including user-friendly training materials and job aids that support process understanding and application.

- Utilize your knowledge of global regulations within a GxP environment to create processes and related documentation that adhere to regulatory requirements, support corporate compliance, and are inspection-ready.

- Contribute to compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards.

- Evaluate global procedural documentation against evolving industry and regulatory requirements, audit/inspection findings, and corporate policies; recommend changes as necessary based on feedback, trends, and best practices.

Qualifications:

- Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management is a plus.

Experience:

- Minimum 3+ years of experience in the design and documentation of pharmaceutical business processes and change management required.

- Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids.

- GxP environment experience required

- Project Management Skills: Proven ability to manage multiple projects simultaneously; PMP certification is an advantage.

- Technical Writing: Background in pharmaceutical technical writing and development of Standard Operating Procedures (SOPs) is essential.

- Organizational Skills: Strong organizational abilities, planning, and multitasking skills; capable of prioritizing multiple projects while meeting tight deadlines.

- Adaptability: Ability to work effectively under pressure and adapt to changing situations with attention to detail.

- Technical Proficiency: Proficient in common desktop tools, including MS Word, MS Excel, MS Project, and Visio and PowerPoint. Sharepoint and MS Teams and Forms a plus.

- Communication Skills: Strong verbal and written communication skills with an in-depth under-standing of pharmaceutical business processes, regulations, guidelines, and industry standards relating to compliance.

Critical Skills/Experience

1) Experience in a GxP environment

2) Strong project management skills with a proven ability to manage multiple projects simultaneously

3) Background in pharmaceutical technical writing, specifically Standard Operating Procedures (SOPs)

4) Ability to create training materials and job aids that facilitate process understanding and implementation

5) Proficiency in using Visio for process mapping and diagram creation

6) Ability to work on critical initiatives under pressure while maintaining a keen attention to detail