Sr. Mgr., Medical Writing Ambit Biosciences
Department: Clinical Development
Job Title: Sr. Mgr., Medical Writing
Job Location: San Diego, CA
The Sr. Mgr., Medical Writing is responsible for managing the medical writing, researching and editing clinical study protocols, investigator?s brochures, clinical data summaries, clinical and non-clinical study reports, and other medical/regulatory documents.
Essential Job Functions:
?Managing and providing guidance for all clinical Medical Writing activities including the content, format and organization of clinical filings.
?Serving as the primary clinical medical writing representative on development stage projects and work closely with personnel from clinical, regulatory, clinical pharmacology, DMPK, and other scientific departments as needed.
?Preparing templates for clinical documents that are consistent with Clinical Department SOPs, FDA and ICH guidelines and with electronic submission guidelines
?Developing the strategy for clinical document preparation, including timeframes that meet or exceed company standards and the document review processes.
?Ensuring adherence to regulatory and clinical guidelines to help produce department guidelines, templates, standard timelines and SOPs.
?Participating in the development of scientific manuscripts, abstracts and slides or posters presenting clinical study data to medical congresses and the development of manuscripts for peer-reviewed journals reporting clinical study data, as well as slides and poster presentations.
?Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts
?Provides QC support for clinical regulatory documents as needed.
?Participates in Clinical Trial Team meetings and other cross-functional team meetings.
EDUCATION:M.S. or Ph.D. in a scientific discipline
EXPERIENCE:Minimum seven (7) years of medical writing, preparing clinical protocols, IBs, abstracts, manuscripts and reviews for clinical trials for biotech/pharmaceutical companies. Experience writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions essential. NDA submission experience preferred.
TECHNICAL KNOWLEDGE:Equipment: PC, scanners, facsimile machine, voice mail and email systems, and other common machines. Must have the ability to be trained on new equipment.
Software Knowledge:Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe.
ENVIRONMENTAL CONDITIONS:Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121