Senior Associate, Product Information/Claims Support

ClinChoice; United States; In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

ClinChoice is seeking a Senior Associate in Product Information/Claims Support (MA) for the United States. The role focuses on optimizing product information, safety data, and regulatory alignment.

You will help develop labeling materials, support scientific communications, and collaborate with cross-functional teams to ensure medical and regulatory accuracy. The position requires a science degree and 3–5 years in pharma/FDA-regulated settings, with hands-on experience in labeling, data

Competenze

• Bachelor’s degree in science or higher in alignment with project/business requirements.
• 3–5 years of relevant experience in identified functional domain/business workstream.
• 4–5 years in a pharmaceutical or FDA-regulated environment such as a medical device manufacturer.
• Background in labeling/artwork management; detail-oriented to catch inconsistencies.

Mansioni

• Identify, plan and implement key projects to improve quality, reduce cost, increase productivity and improve cycle time.
• Target completion of process improvement projects within set timeframes with cost reduction.
• Develop and coordinate performance excellence/ improvement vision and deployment per Executive Team.
• Achieve buy-in from decision makers for performance excellence implementation; create team processes.
• Lead projects and contribute after key projects identified; liaison with finance to report financial benefits.
• Provide status updates and reporting on responsibilities and objectives.
• Develop and maintain CCDS, CSI and high-quality scientific proof, perform compliance checks and compile dossiers.
• Review source documents, perform GAP analysis and contribute regulatory input; prepare SOPs for global labeling.
• Provide therapeutic area knowledge support and contribute to research via publications.
• Conduct literature searches and analyze scientific literature; create standard language for product information manuals.
• Provide medical review for labeling components and collaborate with physicians on cross-functional teams.
• Participate in creating training materials and programs for new employees.
• Train staff on scientific/medical knowledge and support regional speakers.
• Create targeted information in response to literature, media releases, recalls or new discoveries.
• Contribute to research via publications; attend key medical/pharmacy meetings to gain knowledge.
• Research educational materials to support regional speakers.
• Assist in generating safety reports, regulatory submissions, PSURs, CCDS.
• Support Investigator Initiated Studies via correspondence and site review.

Conoscenze

Science degree

Project planning

Process improvement

Stakeholder management

Formazione

Bachelor’s degree in science

Descrizione del lavoro

Senior Associate, Product Information/Claims Support

United States

Job Title

Senior Associate, Product Information/Claims Support (MA)

Department

Medical Affairs/Medical Affairs

Responsibilities

Primary Responsibilities:

• Identify, plan and implement key projects to improve quality, reduce cost, increase productivity and improve cycle time resulting in significant business improvement and customer satisfaction.
• Responsible for targeting completion of process improvement projects within a specified time frame while achieving a cost reduction goal.
• Develop and co-ordinate the performance excellence / performance improvement vision and deployment planning as defined by the Executive Team.
• Achieve buy-in from all decision makers for the successful application of performance excellence / performance improvement. Create team processes for optimizing results.
• Actively lead projects and provide individual contributions after key projects have been identified.
• Liaison with finance and other members of the organization in assessing, tracking and reporting the financial benefit of a Performance Excellence project.
• Provide management with project status updates, feedback, and appropriate reporting on key responsibilities and objectives.
• Development and Maintenance of Client Core Data Sheet CCDS, Core Safety Information (CSI) and high-quality scientific proof.
• Perform compliancee checks, and Compilation and formatting of Dossiers
• Review of source documents, GAP Analysis and providing regulatory contribution Prepare and Review SOP’s for writing Global Labelling documents
• Provide therapeutic area (e.g. Pain, Digestive Health, Smoking Cessation or UR/Allergy) knowledge support and clarification of science as needed and contributes to research activities via scientific publications.
• Conduct and evaluate literature searches and analyze scientific literature.
• Create standard language for product information reference manuals including FAQs for new product launches, media issues, and publications.
• Provide medical support in reviewing the printed packaging components, labeling, and compendia.
• Collaborate with physicians as the medical representative on cross functional teams (copy clearance committees) to both marketed products and support to new marketed concepts for promotional and non-promotional pieces to ensure medical/scientific accuracy.
• Participate in creation of medical training materials and programs that are used to support initial and ongoing training for new employees.
• Train employees who require in-depth scientific/medical knowledge of relevant products/therapeutic areas and in support of local and regional speakers upon solicited request.
• Create and develops strategically targeted information in response to published scientific literature, news media releases, marketing initiatives, product recalls, or new or highly publicized medical discoveries or information.
• Contribute to research activities via scientific publications
• Attend key medical/pharmacy professional meetings to gain knowledge related to therapeutic areas in relevant markets
• Research educational and technical materials in support of local and regional speakers upon solicited request
• Assist in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.
• Support Investigator initiated studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals

Secondary Responsibilities:

• Effectively organize work to complete the assigned tasks to meet deadlines
• Ensure the assigned tasks are delivered 100% on time or before
• Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work
• Support in review of work done by peer teammates, on need basis.
• Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule
• Ensure error free and acceptable quality in assigned deliverables
• Responsible to ensure training compliancee and timesheet compliancee
• Ensure that all assigned goals [e.g. utilization, quality and timeliness] are met as per set standards for the performance year
• Follow and comply with the Company’s Code of Conduct, Policies, and Procedures,
• Responsible for confidentiality, integrity, availability, and safeguarding of data,
• Responsible for reporting of security incidents and PIMS breaches as applicable,
• Comply with company QMS, ISMS and PIMS requirements and applicable regulatory requirements,
• Demonstrate adherence and compliancee to PIMS/GDPR requirements as follows: processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner

Skills and Qualifications

• Bachelor’s degree in science or above and in alignment with project /
• business team requirements
• Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream
• Minimum 4‑ 5 years in a pharmaceutical or consumer health care organization chemical raw material manufacturer or another FDA‑ regulated environment such as a medical device manufacturer.
• Background in labeling / artwork management, in the personal products Must be detail-oriented to pick up inconsistencies or errors in material

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in ClinChoice’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.