Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept.
With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies.
Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements.
Altasciences has facilities in Montreal, QC; Kansas City, KS, Seattle, WA, and Philadelphia, PA.
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal : to contribute to the advancement of life sciences.
Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.
You are experienced in Medical Writing and you want to make a difference by helping to improve people's quality of life, our opportunity will surely interest you! At Altasciences, you will have the opportunity to develop your skills and advance your career.
If you stand out for; your client-focused approach to work, your organizational skills, your ability to prioritize workload and your superior attention to details;
don't hesitate to send us your application!
The Senior Medical Writer is responsible for gathering and synthesizing information for the purpose of providing high quality documents to support the execution and reporting of sponsors' research programs.
Main responsibilities :
Develop clinical protocols for clinical studies of any complexity.
Review and provide feedback on client-provided protocols, as required.
Contribute to risk assessment and management plans (RAMPs) for assigned studies.
Review case report forms (CRFs) and statistical analysis plans (SAPs), as required, to ensure completeness and accuracy of clinical data collection and presentation for final analyses.
Create clinical study reports (CSRs), standalone safety narratives, and integrated safety summaries for studies of any complexity and incorporate results and feedback from other departments assuring compliance with regulations, standard operating procedures (SOPs), Good Clinical Practice (GCP), and client expectations.
Analyze and interpret clinical and safety results for studies of any complexity including vital signs, clinical laboratory values, adverse events (AEs), electrocardiograms (ECGs), diagnostic procedures, etc.
Confirm accurate classification of events and medications using standardized coding systems.
Prepare and review CSR appendices in accordance with project / client specifications and International Conference on Harmonisation (ICH) E3 guidance.
Review and provide assistance on answering deficiency letters from regulatory agencies, as required.
Perform literature searches / reviews as necessary to obtain background information for development of documents.
Coordinate internal review and manage incorporation of external feedback for protocol and CSR documents assuring feedback is appropriately addressed.
Perform quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
Actively participate in internal and external project team meetings, as required.
Maintain familiarity with client expectations and produce documents consistent with these.
Maintain thorough understanding of regulatory guidelines of related authorities (Therapeutic Products Directorate TPD , Food and Drug Administration FDA , European Medicines Agency EMA , etc) as well as ICH and GCP procedures.
Support training of Medical Writers and Medical Writing Associates.
Assist in coordination of team workload.
Desired Profile :
Master’s Degree in health-related sciences or relevant field, advanced degree preferred;
7 years' experience in writing and clinical research;
Understanding of clinical research, drug development process, and applicable regulatory guidelines;
Excellent verbal and written communication skills.
Ability to acquire and apply knowledge quickly.
Professional attitude and strong interpersonal skills.
Ability to work well with a multi-disciplinary team of professionals.
Flexible attitude with respect to work assignments and new learning.
Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.
Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.
Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
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