Senior Manager / Associate Director, Medical Writing (Remote)

Company: Atara Biotherapeutics
Location: South San Francisco
Posted on: June 12, 2021

Job Description:

Job Description

The Sr Manager / Associate Director, Medical Writing is responsible for clinical development and safety (pharmacovigilance) regulatory documents and other clinical/safety content across the Atara Bio product pipeline. This position collaborates with a variety of functional areas to prepare and deliver documents and content covering all phases of clinical development in support of global regulatory filings.

Reports to: Director, Medical Writing

Location: This position can be fully remote with at least a few trips per year to the Los Angeles office - Must be willing to work West Coast/Pacific time hours

Key Responsibilities:

• Manages the documents and provides cross-functional teams direction on document content and innovative solutions to document preparation.
• Prepares/writes and/or oversee the preparation of clinical and safety regulatory submission documents that comply with global regulatory requirements, including investigator's brochures, study protocols, study reports, clinical summaries/overviews, integrated reports, safety update reports, risk management plans, and contributes clinical content to other regulatory documents.
• Drives the document development process from gathering materials and developing scientifically rigorous content to facilitating document review meetings and discussions and assuring adherence to electronic submission standards.
• Contributes to building the medical writing function through the development of internal processes, procedures, and templates that support efficient and compliant document preparation.
• May prepare scientific/technical documents and support clinical study transparency and disclosure activities.

Qualifications

• Doctorate degree with 3+ years of regulatory medical writing in a biopharmaceutical setting along with other scientific/technical writing experience; OR Bachelor's degree with 7+ years of medical writing experience.
• Experience in writing regulatory documents intended for worldwide use, which is based on an advanced knowledge of international regulations and guidelines governing the documents.
• Familiarity with AMA Style guide and clinical research terminology.
• Exceptional written communication skills including the ability to independently interpret and summarize complex results.
• Excels in an environment where the full array of scientific/medical writing skills can be utilized.
• Succeeds in a matrix team setting and meets or beats timelines every time.
• Proficient editing skills along with expertise in Microsoft Office and Acrobat applications.
• Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)

More about Atara Bio

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

We're proud of our team of 425+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility. Our mission - "Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence."

Our vision - "T-Cell Immunotherapy for every patient, any time."

Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit www.atarabio.com/careers to learn more.

Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual's association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.

Keywords: Atara Biotherapeutics, South San Francisco , Senior Manager / Associate Director, Medical Writing (Remote), Other , South San Francisco, California