MannKind
Contract-to-Hire, Sr. Manager, Medical Writing Job at MannKind in Westlake Villa
MannKind, Westlake Village, CA, United States, 91361
MannKind Corporation is dedicated to developing and commercializing innovative therapeutic products for patients with serious unmet medical needs. Our focus is on the discovery, development, and commercialization of therapeutic products for diseases such as diabetes and other endocrine disorders.
Position Overview: As a key member of the Medical Affairs team, the Sr. Manager, Medical Writing (Consultant/Temp-to-Hire) is responsible for interpreting, analyzing, writing, formatting, and producing clinical development and medical affairs documents. This includes final clinical study reports, regulatory agency submission documents across several therapeutic areas as well as abstracts, posters and manuscripts. The Sr. Manager will work with various teams to ensure that all parties contribute to and approve the final documents according to planned timelines.
How You’ll Make an Impact:
- Author the first and subsequent drafts of clinical study reports from data generated from clinical studies, interpreting data from tables and graphs and presenting them in written and diagrammatic formats.
- Utilize statistical and medical literature evaluation skills to compare data and potential citations for document generation, ensuring completeness, accuracy, and appropriate style.
- Organize material with co-authors, format, and coordinate internal review processes, preparing clinical reports for final sign-off according to departmental SOPs.
- Authors drafts of documents, abstracts/posters and manuscripts from clinical study data, other internal sources or published literature.
- Provide authorship support to Medical Directors for protocol shells, updating investigator brochures, annual safety reports, and regulatory documents such as sections of Biological License Applications to FDA and other regulatory agencies.
- Assist the publications planning team in integrating the science of MannKind products and relevant clinical study results into strategic publication planning and execution.
- Interface with and assist physicians and key opinion leaders in preparing and providing editorial assistance for MannKind sponsored publications.
- Maintain the Clinical Study Registry and Results Disclosure, interfacing and uploading clinical protocol registration data and clinical study report disclosure data to FDA CT.gov, EU, and other worldwide website registries.
What You’ll Need (Required):
- Bachelor's degree in science or related field with 11-12 years of related experience in medical affairs, clinical affairs, and/or clinical science; OR Advanced degree (MS, PhD, or PharmD) preferred.
- Master’s degree in a related field with 8 years of related experience in medical affairs, clinical affairs, and/or clinical science; OR
- Doctorate degree (PhD, MD, PharmD) with 6 years of related experience in medical affairs, clinical affairs, and/or clinical science.
What Else We Look For (Preferred):
- Familiarity with the endocrinology therapeutic area and current treatment options or other clinical and/or clinical trial experience.
- Excellent scientific, technical and clinical studies knowledge.
- Excellent knowledge of MS Office, Viso, ISI Writer, Reference Manager, and medical/scientific search/retrieval tools. Experience with literature reviews and various publication databases.
- Experience working in a cross-functional, collaborative environment and comfortable interacting with R&D, regulatory specialists, physicians, statisticians, and support personnel.
Additional Skills and General Expectations:
- Demonstrated ability to work independently, prioritize, and manage multiple tasks simultaneously.
- Excellent oral and written communication skills.
- Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
- Strong analytical, problem-solving, and scientific writing skills.