Jobs at Thermo Fisher Scientific

Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Pharmacist of the ICRPMC government contract (Southern Trials) provides support and investigational (Clinical Trial Research} medicines storage and distribution for US government clients (NIAID/Division of AIDS) in accordance with Good Pharmacy Practice.

Main Responsibilities:

• Main Task: To provide supportto Clinical Research Products ManagementCenter(CRPMC)and NIAID/Division of AIDS) in storage and distribution of clinical trial research products in accordance with Good Pharmacy Practice, Good Distribution Practice and Good Manufacturing Practice.To achieve this Task, you will assist and supportthe Pharmacists and Team in the following responsibilities:
• Review, monitor and process protocol-related clinical site orders,from receiving the order through to delivery:
• Monitoring orders in COSMOS and from email communications,processing in COSMOS and Manually: Reviewing, verifying,checking and approving orders. Verify correct choice of samples from inventory for each order.
• Working and communicating with the Technicians on processing the orders and check pulled orders against paperwork and COSMOS.
• Interface and interact with customers: CRPMC, Division of AIDS (PAB) and clinical trial site Pharmacists on all matters related to study product orders and shipments (by telephone and email communication).
• Prepare paperwork for International Sites and send it to the Sites and the Couriers forimpo rt permit and approval to ship. Process approved orders and check orders against paperwork after being pulled by Technicians.

Additional Key Job Functions / Tasks:

• Assist with preparation, reviewing, revision and updating of controlled documents when requested (SOPs, Forms and SWls}. Update the documents in Master Control.
• Assist with Trial Master File (TMF) filing (updating in the P: drives) and supervising the physical archiving of shipping documents for all the protocols.
• Assist with keeping the Site Address File for Shipments updated.
• Assist with handling custom er queries (e.g. on clinical site orders, Quality Assurance and Complaints) when requested.
• Assist in supervision and monitoring of good housekeeping, environmental monitoring and control, cold chain maintenance in the warehouse and storage equipment.
• Assist to supervise and participate in periodic stock counts and destruction of obsolete study products.
• Auxiliary Labeling: Assistto prepare batch record for Auxiliary Labeling of study products '.'.{ith protocol number and perform QC checks.
• Assist with any other special work requests/ assignments made by RP or Pharmacist that may be necessary.
• Undergo all required training including SOPs, online training (i-Comply and TFU), PPI and practical training in orderto perform your duties as expected. Record the training performed.

Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.

• Requires knowledge of laws and regulations governing pharmacy services.
• Requires working knowledge of import/export requirements for clinical study products.
• Requires excellent analytical, research, written, editing, interpersonal and verbal communication skills.
• Requires knowledge of procedures for handling and shipping bio-hazardous agents
• Requires skills in medical discipline, proficiency with computer word processing.
• Requires proficiency using lnternettools to obtain technical reports from Government and other Web sites.
• Requires ability to effectively work and communicate with staff and project personnel on technical issues.
• Requires strong organizational skills, detail oriented, and ability to work with multiple projects.
• Requires knowledge and experience with current Good Manufacturing Practices (cGMPs).

Education/ Experience:

• Requires a Bachelor's of Science Degree in Pharmacy.
• Requires 1+ years of experience in the pharmaceutical industry.

Certificates and/ or Licenses:

• SA Pharmacy Council Registration.

Supervisory Responsibility:

• Assists with managing Pharmacy Staff in the absence of senior pharmacists.

Work Conditions/Physical Requirements:

• Must use personal protective equipment and adhere to safety protocols.
• Must be able to lift and carry up to 50 lbs.
• Must be able to work in walk-in freezers or refrigerators periodically.
• Must be able to use a computer up to 8 hours per day.
• Must be able to work in a laboratory and warehouse/repository environment.

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Summarized Purpose:

• As a Senior Medical Writer within the FSP team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Essential Functions:

• Serves as primary author for FSP clients, who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
• May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods, and techniques for achieving optimal results, including various client specific processes.
• May assist in program management activities. Identifies and resolves out of scope activities. Duties could include developing timelines, budgets, forecasts, and contract modifications.
• Represents the department at project launch meetings, review meetings, and project team meetings.

Education and Experience:

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience working in the pharmaceutical/CRO industry preferred.
• Experience working within FSPs preferable.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal skills including problem solving.
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national, and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).