Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered at The Spiral in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer and his cousin Charles F. Erhart.

Study Operations Manager

The Country Study Operations Manager (cSOM) is responsible for regional/country level activities from study startup through conduct and study close. The cSOM partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Site Care Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out. The cSOM has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team. The cSOM may help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks. The cSOM ensures the operational delivery of responsible tasks within the assigned studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

Accountable for the execution of tasks and developing solutions to problems as needed to support deliverables. The cSOM will be accountable and responsible for tasks as designated on the study by the Global Study Manager which may include:

• Regional/Country level implementation of Startup and Site Activation Plans

• Regional/Country level Recruitment Strategy

• Responsible for development of country level plans

• Communication with the local team and internal stakeholders and pCRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans

• Responsible for country vendor management and oversight including follow up and coordination of vendor deliverables

• Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc.

• Work independently and exercise their own judgement.

• Responsible for management/oversight of regional/country level activities from study startup through conduct and study close

• May manage the study start up process in countries assigned and/or oversee pCRO responsible for these activities as applicable

• Through the Site Care Partner, supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements

• Provides country level input on Startup and Recruitment milestones as provided by Site Care Partner to Global Study Manager during planning

• Is accountable for overseeing Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)

• Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation

• Leader of the Local Study Team (core members: Site Care Partners, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)

• Ensures compliance to relevant Global and Local, internal and external requirements and regulations

• Ensures timely communication bidirectionally between the global and local study team.

• Provides protocol level guidance and support to responsible Local Study Team members as applicable.

• Liaise with Site Care Partner, Site Activation Partners and Regulatory colleagues in

country to agree on submission strategy to Health Authorities and Ethic Committees

• Utilizes roles in country such as Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered

• Follows up on region/country level issue status to ensure resolution.

• Identifies country level trends to improve deliverables processes as needed

• Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies

• Ensures audit/Inspection readiness during start-up and conduct

• Manages applicable Quality Events with local team as applicable and required

• Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets

• Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable

• Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable

• May act as a Subject Matter Expert

• May lead operational effectiveness initiatives at country or regional level

• Responsible for PTA and SIV report review for reports completed by the Site Care Partner

• Supports implementation of Pfizer’s Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM)

• Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines

• Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness

• Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions

• Ensures applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required

• Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.)

• Support Identification, contract development and management of local vendors or facilities as per protocol

• Investigator Meeting support and management including doing presentations as appropriate

• Management of local Investigator Meetings including doing presentations as appropriate

BASIC QUALIFICATIONS

• Relevant operational Clinical Trial experience. A scientific or technical degree is preferred along with knowledge of clinical trial methodology

• BA/BS 5+ years of relevant experience

• MBA/MS 3+ years of relevant experience

• BS/BSc/MS/MSc

• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility

• English is required.

Prior Experience

• Demonstrated clinical research experience and/or study management/startup project manager experience

• Demonstrated experience in managing country level operational activities and/or vendors

• Experience in Study and Quality management and working in a matrix management environment

Skills and Technical Competencies

• Expertise in the use of study/site dashboard and reporting tools

• Detail oriented & possesses technical expertise

• Ability to manage moderately complex processes

• Ability to operate in a matrix environment

• Risk Identification & Mitigation

• Strategic Planning, Analytical and Problem-Solving Skills

• Critical Path Analysis

• Excellent communication skills, both written and verbal

• Ability to adapt to changing technologies and processes

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Associate Manager, Medical Communications and Content Solutions

Responsible for providing support to the Pfizer Biopharmaceuticals Group (PBG), CMAO-Global Medical Excellence & Innovation, Global Medical Affairs team specifically:

•     Support development of abstracts, posters, manuscripts, congress presentations and slide decks as per the required business needs under the supervision of Publications writer.

•     Perform requisite data mining as per the requisite needs of the document.

•     Responsible for data quality control of all documents and ensure that data is objectively and accurately represented

•     Adherence to general publication policies and company policies on all documents.

•     Provide regular updates on projects using trackers and presentations as per pre-specified format.

•     Train on developing plain language summaries for all manuscripts, as applicable.

•     Scientific support at congresses including development of materials and reports.

•     Providing support to the Medical Affairs group including but not limited to literature reviews and summaries, preparation of slide decks.

•     Ensuring delivery of all required activities within expected timelines, on budget and adhering to all requisite guidelines.

The Associate Publications Writer supports the Publications Writer and the Global Medical Affairs by:

•     Supporting manuscript writing including researching, organizing, compiling, and quality checking various types of technical and/or medical information.

•     Creating slides, abstracts, training materials, and style guides, as needed for our clients and their diverse audiences.

REQUIRED SKILL SET

Technical

•   Writing skills:  Good scientific writing skills, including an ability to interpret and summarize complicated data effectively, concisely and persuasively.

•   Analytic skills: Utilize tools such as OvidSP and other bibliographic databases such as PubMed, Medline, Embase, and Biosis. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.

•   Language skills:  High fluency in written English and strong functional fluency in spoken English.

•   Personal skills: Strong organizational skills and ability to prioritize multiple projects and meet deadlines. Able to maintain confidentiality and pay attention to details.

•   Interpersonal skills: Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy.

•   Software: Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel and reference management tools such as EndNote) is required. Experience with searching literature and freely accessible databases (e.g. for antimicrobial resistance related) is preferred.

Managerial

•    Reports directly to the Publications Lead-GMAIST.

•    Works closely with Publications Writer Global Medical Affairs Leads and Publication coordinators.

•    Interacts with Medical Affairs colleagues, Local, Regional and at a Global level.

Certifications

NA

Education

•    Post-graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees.

Experience

• 2 to 3 years relevant experience for medical graduates/PhDs. More than 3 years relevant experience for masters in life sciences.
• Minimum 2 years of experience in publication writing in academic settings/ communications experience within an agency, CRO, Pharma / Biotech Company. Prior experience in using search tools, developing search strings and assessing search results and data analysis is preferred.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Junior Officer

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will be responsible for generating work orders and ensuring that work is completed correctly in a timely manner.  Your knowledge in the domain will help in providing detailed technical training to colleagues. You will support the work team operation to ensure that applicable safety guidelines/policies are followed, and that all tasks are conducted in accordance with appropriate processing standards, such as current Good Manufacturing Practices (cGMPs).

As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Manage own time, professional development and be accountable for own results.
• Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
• Keep accurate records as needed for solution manufacture and prepare solutions as directed by work order.
• Recognize when processes, procedures, equipment, product, commodities, etc. are out of specifications.

• Check improper use or monitoring of equipment that may result in substantial downtime, equipment and material or product loss.
• Support supervisor to execute investigations, analyze process data and identify and implement process improvements.
• Prepare regular reports and metrics from Pfizer’s Learning Solution and Quality Tracking System to identify training needs and progress with the unit.

Qualifications

Must-Have

• High School Diploma or GED
• Demonstrated good oral and written communication skills

Nice-to-Have

• Bachelor’s Degree
• Pharmaceutical Experiance in manufacturing operations

Executive Production

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

Your expertise in the manufacturing domain will help you in communicating and directing the activities of employees in the production areas in an effective manner. You will be entrusted with addressing deviations to process problems in the production areas and manage timely equipment maintenance. You will ensure current Good Manufacturing Practices compliance, meet area performance measures, and promote employee training.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Respond to safety related items and assures corrective actions are taken when necessary.
• Responsible for identifying and implementing efficiency, safety, quality and cost improvements on equipment and processes.
• Promote cGMP (current Good Manufacturing Practices) compliance within the workplace by following site cGMP procedures.
• Assures standard operating procedures are updated and adhered.
• Develop appropriate metrics and action plans to ensure customer/business needs are met.
• Manage supervision of inspection, reconciliation or dispensing and receivals of components.
• Apply project management skills to lead and participate in cross-functional teams to deliver objectives on time.

Qualifications

Must-Have

• Bachelor’s /master’s degree
• Effective verbal and written communication skills
• Demonstrated proficiency in MS Office programs, including MS Project or equivalent

Nice-to-Have

• Pharmaceutical experience in manufacturing.