JOB TITLE: Head of Medical Writing (D/SD)              LOCATION: South San Francisco

DIVISION: Product Development                               DEPARTMENT: Regulatory 

REPORTS TO: Vice President, Regulatory Science 

 

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.                                               

This position has the potential to be fully remote. Occasional travel may be required for in person meetings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

The Head of Medical Writing responsibilities include, but are not limited to:

 

·       Work collaboratively to incorporate and adjudicate comments from internal stakeholders in document development for the production of high-quality final documents.

·       Participate in the writing, editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents.

·       Critically analyze complex data and information and collaborate with clinical, medical, biostatistics, and data science teams on data analysis, description, and presentation.

·       Collaborate with outside vendors to develop related graphics and figures.

·       Interact with internal stakeholders and with external service providers to ensure the timely development, review, and publication of documents.

·       Have a demonstrated ability to produce clear, concise, and effective written and verbal communication that describes scientific and clinical data in clear English.

·       Write and coordinate the development of protocols, clinical study reports, and other clinical and regulatory documents, including those of a more complex nature.

·       Ensure quality control and robust formatting of final documents.

·       Provide support in development of submission-level documents under the guidance of senior management.

·       Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget across all compounds and indications, all while managing internal Medical Writing staff and external vendors.

·       Prioritize and plan workload to effectively manage multiple assignments in parallel.

·       Assign projects to internal Medical Writing staff and external vendors for best use of writer expertise.

·       Prepare documents in accordance with company SOPs and specification as applicable and in accordance with relevant ICH and regulatory and/or industry guidelines.

·       Review Statistical Analysis Plan and tables, figures, and graphs to ensure appropriate data presentation for clinical study reports.

·       Inform management of Medical Writing problems promptly, preferably with proposed solutions.

·       Provide advice on Medical Writing issues to internal and external project teams to help resolve problems.

·       Represent department ins audits and cross-functional teams.

·       Coordinate Medical Writing budget with senior management.

                                                                                                            

SUPERVISORY RESPONSIBILITIES:

-       Team of Medical Writers and Medical Writing vendor

 

REQUIREMENTS:

 

·       An advanced degree preferred; a minimum of 8-10 years of experience in medical writing in the biotech, pharmaceutical, and/or medical communication field

·       Expertise in written and spoken English

·       Excellent collaboration skills

 

DISCLAIMER

 

The preceding job description has been designed to indicate the general nature and level of work performed by employees within thisfication.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

 

Day One Biopharmaceuticals is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

 

Recruitment & Staffing Agencies: Day One Biopharmaceuticals do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HRteam. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.

 

Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date.  Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.