The Incumbent will be responsible for independently authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to lead other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals. Will be expected to support multiple studies, programs, and/or indications. Will ensure the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members. Mentor/train junior writers. This position can be fully remote.Key Responsibilities
Qualifications and Education Requirements
- Write and coordinate the development of protocols, CSRs or other clinical documents including those of a more complex nature.
- Provide support in development of submission level documents under guidance of senior staff.
- Review and approve clinical regulatory documents including: study plan outlines, synopses and protocols, and documents for regulatory submissions (e.g. meeting packages, Investigational New Drug (INDs) applications, and sections of marketing applications (NDA/BLA/MAA), Investigator Brochures, or other clinical and regulatory documents).
- Oversees management and coordination of complex narrative projects.
- Produces scientific papers, abstracts and / or posters, and presentations.
- Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget.
- To prioritize and plan workload to a high standard. Effectively manage multiple assignments in parallel.
- Prepare documents in accordance with Amador Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory / industry guidelines.
- Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
- Act as scientific writing contact for major clients and partners.
- Review Amador SOPs and associated documents.
- Represent department in audits and inter-department working groups.
- Comply with Amador internal processes and procedures.
- Minimum 8 years scientific/medical writing experience, life science/medical academic background.
- Strong written and oral communication skills, proficient with Microsoft Office software, particularly Microsoft Word and SharePoint.
- A minimum of 3 years experience reviewing and approving clinical regulatory documents.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Experience working in a deadline driven environment.
- Detailed knowledge of ICH guidelines applicable to medical writing.
- Good understanding of medical / scientific terminology and experience in data analysis and interpretation.
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- Understanding of global pharmaceutical drug development.