Senior Manager / Associate Director, Medical Writing (Remote)
Company: Atara Biotherapeutics
Posted on: June 12, 2021
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
- Manages the documents and provides cross-functional teams
direction on document content and innovative solutions to document
- 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.
- 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
- Experience in writing regulatory documents intended for
worldwide use, which is based on an advanced knowledge of
international regulations and guidelines governing the
- Familiarity with AMA Style guide and clinical research
- 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
- 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
Our vision - "T-Cell Immunotherapy for every patient, any
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, Eugene , Senior Manager / Associate Director, Medical Writing (Remote), Other , Remote, Oregon
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