13 days old

EG-Associate II, Medical Writing

Hedgesville, WV 25427
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**Primary Responsibilities**

+ Prepares, edits, and finalizes CSRs or related documents

+ Collaborates with biostatisticians and clinical colleagues to interpret study results

+ Works with groups outside CPW, e.g. Regulatory, CSR Coordinator, Clinical Trial Disclosure Group, QA

+ Participates actively in clinical study teams in the development of clinical study documents

+ Understands the functions and roles within the study team and aligns with them in delivery of CSRs to meet project-related goals and to meet external results disclosure obligations

+ Ensures CSRs accurately reflect the data presented in the statistical tables and listings and other information sources

+ When required, prepares, edits and finalizes the clinical study protocol and any amendments in collaboration with team members (e.g., Clinician, Clinical Pharmacologist, Safety Risk Lead, Statistician).

+ Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines

+ Ensures documents are generated in accordance with agreed internal processes and standards (e.g. Pfizer Global Document Style Guide), are submission ready, and appropriately stored in agreed document management system

+ Ensures that appropriate quality control (QC) checks are performed on CSRs and other medical writing deliverables

+ Provides thorough and critical review or peer QC support of documents prepared by others, as needed

+ Ensures 'public disclosure' related components of CSRs are finalized to enable timely release of results into the public domain

+ Supports corporate audit and regulatory inspections through attendance of related inspection meetings and has thorough documentation procedures integrated into daily work practices so as to facilitate such inspections

+ Develops and maintains knowledge of all applicable global regulations and guidelines, SOPs, and practices

+ Ensures own work processes are constantly improved to reflect lessons learned from previous experiences

+ Work with other group members to enable improved quality and consistent format of CSRs

+ Participates in CRDC and CII initiatives to increase efficiency and productivity; may lead selected teams in these efforts

+ Implement recommendations for improvements to the CSR process

+ Align with department management to set strategy for meeting department goals

+ When needed, write or help write other clinical and regulatory documents not mentioned above

**Technical Skill Requirements**

+ Excellent verbal and written English language skills

+ Demonstrates understanding of clinical data and has ability to communicate it succinctly, clearly, and accurately

+ Knowledge of ICH guidelines and regulatory requirements and demonstrable ability to interpret and apply these guidelines in a report writing setting

+ Ability to guide others in application of internal or regulatory guidelines

+ Demonstrated excellent project management skills

+ Basic knowledge of using Windows OS, MS-Word, MS-Excel, and MS-Outlook

+ Basic experience of working in electronic document management systems

**Qualifications (i.e., preferred education, experience, attributes)**

+ At least BS or equivalent in the medical or life sciences field

+ Good understanding of pharmaceutical R&D processes

+ Knowledge of global regulations and guidelines (FDA, ICH) and regulations of China and other Asian countries that pertain to the drug development process and production of CSRs

+ Experience in interacting with cross functional study team members

+ Experience in preparation of ICH E3-compliant CSRs within the pharmaceutical industry

+ Demonstrates good communication skills in a variety of media settings (e.g. teleconference).

+ Ability to present with ease to both scientific and non-scientific audiences

+ Attentive to details

+ Demonstrates strong interpersonal skills and has the ability to work in a multi-cultural environment

+ Ability to communicate professionally with cross-functional lines, scientific staff from a range of disciplines, and all levels of management

+ A balanced approach to problems, using flexibility and persistence as appropriate

+ Ability to deliver within agreed timelines and communicate progress against agreed milestones

+ Ability to multi-task and work effectively under pressure; demonstrate excellent project management skills

+ Ability to work independently with minimal supervision

+ Demonstrated ability to focus on the customer, while setting realistic expectations for them

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

Posted: 2020-10-13 Expires: 2020-11-13
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EG-Associate II, Medical Writing

Hedgesville, WV 25427

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