This is a full-time, on-site Sr. Medical Writer position in North Carolina. If qualified candidate is already located in NC, it can be a split on-site and remote. Full relocation is available. My ideal candidate has a PhD in a scientific discipline, significant experience writing full clinical study reports, and a strong clinical research background.
My client is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. Their mission is to utilize our innovative technology to rapidly translate the functional modulation of human proteins into safe and effective medicines. My client has a pipeline of small molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases including central nervous system disorders, cardiovascular disorders, type I/II diabetes, obesity, and cancer. They have built a product candidate portfolio through internal discovery and are advancing the product candidates through in-house research and development efforts. In addition, they have strategic collaborations with leading pharmaceutical and biopharmaceutical companies that have contributed to the portfolio of product candidates. My client believes the quality and breadth of the product candidate pipeline, platform technology, scientific team and strategic collaborations will enable them to become a fully integrated pharmaceutical company. My client has 10 phase I/II compounds and one phase III and a very strong preclinical pipeline.
The Sr. Medical Writer is responsible for preparation and coordinating of development of draft and final protocols, protocol amendments, Investigator Brochure, study manuals and Clinical Study Reports for Phase I/II studies as well as interpretation of clinical, pharmacokinetic, pharmacodynamic, and statistical results, as appropriate for Phase I/II studies.
Job Duties and Responsibilities:
Prepares scientifically valid draft and final CSRs (i.e., interim and abbreviated CSRs to fully integrated CSRs), including the scientific interpretation of data and writing of clinical, pharmacokinetic and pharmacodynamic results, discussion and conclusions, for studies of intermediate complexity
May be a secondary reviewer of data listings and study data as appropriate, prior to database lock, for consistency and scientific integrity
Participates in the review of the draft and final statistical analysis plan (SAP), in cooperation with the project team. Reviews SAPs to ensure the data presentation and analysis methodology are consistent with the study objectives
Communicates with internal staff and the external study contact(s) to obtain all relevant information needed to adhere to the project schedule
Has written summary sections (IND, NDA, etc) and similar medical and regulatory-related documents
Prepare literature reviews and bibliographies
Writing clinical development plans, to include scientific background and clinical trial strategy
Responsible for proper strategy for efficient medical writing and clinical document development functions
Act as medical writing liaison to work with medical directors, clinical operations, biostatistics and data management and clinical QA and compliance
Manages review process of all clinical documents
Helps biostatistics and regulatory affairs groups in regulatory submissions
Provides assistance in preparation of abstracts, manuscripts and other presentations for scientific meetings.
Looks for ways to improve the efficiency and quality of work processes as appropriate
Writes and coordinates the development of study protocols and protocol amendments
Detailed knowledge of FDA and ICH guidelines and regulations related to the format, content and integrity of documents.
Required Education:
PhD in science/medical field preferred
Required Experience:
Minimum of 3-5 years professional medical writing experience
Experience writing for Phase I/II studies
Contact:
Ian Leventhal
Evan Thomas Global LLC
111 S. Albany Ave. #101
Tampa, FL 33606
941-735-6439
941-371-5676
ian.leventhal@evanthomas.com
www.evanthomas.com
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