Sr. Manager / Associate Director, Medical Writing

Clinical Science South San Francisco, California Westlake Village (Los Angeles), California

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. 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.


Position Summary
We are seeking an experienced Sr. Manager / Associate Director, Medical Writing to join Atara Bio. The successful candidate is responsible for clinical regulatory documents and other clinical content across the Atara Bio product pipeline. This position collaborates with a variety of functional areas to prepare and deliver documents and content in support of global regulatory filings and covering all phases of clinical development.

Contract positions may also be available.

Reports to   

 

Director, Medical Writing

Location

 

Westlake Village (northwest Los Angeles) or South San Francisco, CA.

 

Remote location in the Pacific time zone possible for the successful candidate who also has exceptional oral communication skills and demonstrated effectiveness working in a remote capacity.

 

Primary Responsibilities

  • Prepares/writes and oversees the preparation of clinical regulatory submission documents that comply with global regulatory requirements, including investigator’s brochures, study protocols, study reports, clinical summaries/overviews, and integrated reports, and contributes clinical content to other regulatory documents and publications.
  • 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.
  • May prepare safety and scientific/technical documents and support clinical study transparency and disclosure activities.

Travel                   Ability to travel, up to 15% travel time.

Physical Requirements
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel is an essential part of the job.


Position Requirements

  • Preferred: Doctorate degree with at least 2 years of regulatory medical writing in a biopharmaceutical setting along with other scientific/technical writing experience; minimum: Bachelor’s degree with 7 years of medical writing experience.
  • Expertise in writing clinical regulatory documents intended for worldwide use which is based on an advanced knowledge of international regulations and guidelines governing the documents.
  • 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 Word and Acrobat applications.
  • Experience writing safety (pharmacovigilance) and scientific/technical (preclinical/CMC) documents a plus.
  • Teams well with others.
  • Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.

More About Atara Bio
Now in our sixth year, we’re proud of our team of 260+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. 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 in Thousand Oaks, California.

One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”

The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.

Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).

Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).

 

Working at Atara Bio
People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.

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.