Sr. Medical Writer Ambit Biosciences
THIS JOB HAS EXPIRED Description:
The Sr. Medical Writer is responsible for writing and editing Clinical Development documents, including but not limited to clinical protocols, investigator?s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, and presentation materials. The Sr. Medical Writer will collaborate with Regulatory Affairs and other departments to prepare clinical sections for IND updates, IND submissions, and submissions to regulatory agencies.
Essential Job Functions:
?Collaborates with clinical operations, data management, and other departments on the development and/or revision of protocols, protocol amendments, subject consent forms, clinical study reports, safety narratives, integrated safety and efficacy summaries, Investigator?s Brochures, presentation materials, etc.
?Takes ownership of a given assignment, proactively consulting other project team members (e.g. clinical project manager, clinical research associate, biostatistician) and other department representatives (e.g. regulatory affairs, toxicology, pharmacokinetics) for information or guidance, as necessary.
?Completes writing assignments accurately in a timely manner, ensuring that strategically aligned communication points are consistent across program documentation.
?Ensures proper version control of all applicable documents.
?Maintains timelines and workflow of writing assignments.
?Participates in development of publication strategy, meeting with cross-functional departments.
?Performs editorial functions for written documents.
?Prepares templates for clinical documents that are consistent with Clinical Department SOPs, FDA and ICH guidelines, and with electronic submission guidelines.
?Ensures adherence to regulatory and clinical guidelines to help produce department guidelines, templates, standard timelines and SOPs.
?Participates 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.
?Provides QC support for clinical regulatory documents as needed.
?Participates in Clinical Trial Team meetings and other cross-functional team meetings.
?Can exhibit excellent inter-personal communication skills.
EDUCATION:Bachelor?s degree in health science or related field. Master?s degree preferred.
EXPERIENCE:Minimum four (4) years of medical writing. Contribution to NDA documents 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.
Laboratory Activities, if applicable: Experience with biological, animal, and chemical laboratory environments required. Environmental health and safety processes also apply.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED