Associate Director, Medical Writing
The Associate Director, Medical Writing will report to the Senior Director of Medical Writing. The individual will plan, author, and manage regulatory/clinical documents to support clinical development programs and regulatory submissions. The Associate Director, Medical Writing also manages vendors to prepare regulatory/clinical documents. The option to work remotely with occasional travel to South San Francisco. Essential Duties and Responsibilities (include but not limited to):
Acts as a medical writing subject matter expert for all clinical and regulatory document preparation Collaborates with the Nonclinical, Clinical, and Regulatory Affairs team members to plan and prepare high quality documents under strict timelines; documents may include clinical study protocols/amendments, clinical study reports, scientific advice briefing documents, investigator brochures, safety updates, orphan designation requests, Module 2 clinical summaries and the Clinical Overview for INDs and marketing applications, and regulatory responses May oversee or contribute to the preparation of scientific publications (ie, manuscripts, abstracts, posters, and oral presentations) Ensures key messages are clear and consistent within and across documents Contributes strategically and scientifically at the project and/or study team level Works closely with functional leadership and cross-functional project teams to ensure effective document prioritization and development Demonstrated ability to communicate and write clearly, concisely, and effectively; strong aptitude for interpretation, compilation, and presentation of data Ability to work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external team members Maintains corporate standards for clinical document preparation including formatting, style guide, review and approval processes, and optimal use of technology Manages external medical writing resources, i.e., contract research organizations, document quality reviewers, and freelance medical writers as needed Contributes to the development and standardization of templates and related processes, including updating, revising, and developing relevant SOPs and internal best practices
Qualifications:
Strong scientific written and oral communication skills. Commitment to detail, and ability to effectively prioritize while working on multiple programs and projects Ability to clearly communicate and understand complex clinical and scientific concepts across therapeutic areas is essential Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Ability to meet deadlines using both internal and external resources Demonstrates strong problem solving and analytical abilities Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents Education and
Experience:
7-11 years medical writing experience in biotech/pharmaceutical industry with a BS or equivalent degree; advanced degree preferred, i.e. PhD, PharmD 3
years of experience leading teams and/or managing people (i.e. employees, contractors,) desired for leadership positions Demonstrated experience in preparing protocols, study reports, investigator brochures, and eCTD clinical summary documents, including regulatory submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) Medical writing experience for international regulatory submissions is a distinct advantage Experience with integrated electronic document management systems; Veeva Vault preferred Proficiency with Microsoft Office and use of electronic document templates Experience analyzing and selecting references based on scientific and regulatory relevance; familiarity with PubMed and/or other reference-gathering search tools Proficiency with Adobe Acrobat and Electronic Common Technical Document (eCTD) templates Familiarity with Good Clinical Practice (GCP) and applicable regulatory requirements and guidance documents, i.e., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Acts as a medical writing subject matter expert for all clinical and regulatory document preparation Collaborates with the Nonclinical, Clinical, and Regulatory Affairs team members to plan and prepare high quality documents under strict timelines; documents may include clinical study protocols/amendments, clinical study reports, scientific advice briefing documents, investigator brochures, safety updates, orphan designation requests, Module 2 clinical summaries and the Clinical Overview for INDs and marketing applications, and regulatory responses May oversee or contribute to the preparation of scientific publications (ie, manuscripts, abstracts, posters, and oral presentations) Ensures key messages are clear and consistent within and across documents Contributes strategically and scientifically at the project and/or study team level Works closely with functional leadership and cross-functional project teams to ensure effective document prioritization and development Demonstrated ability to communicate and write clearly, concisely, and effectively; strong aptitude for interpretation, compilation, and presentation of data Ability to work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external team members Maintains corporate standards for clinical document preparation including formatting, style guide, review and approval processes, and optimal use of technology Manages external medical writing resources, i.e., contract research organizations, document quality reviewers, and freelance medical writers as needed Contributes to the development and standardization of templates and related processes, including updating, revising, and developing relevant SOPs and internal best practices
Qualifications:
Strong scientific written and oral communication skills. Commitment to detail, and ability to effectively prioritize while working on multiple programs and projects Ability to clearly communicate and understand complex clinical and scientific concepts across therapeutic areas is essential Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Ability to meet deadlines using both internal and external resources Demonstrates strong problem solving and analytical abilities Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents Education and
Experience:
7-11 years medical writing experience in biotech/pharmaceutical industry with a BS or equivalent degree; advanced degree preferred, i.e. PhD, PharmD 3
years of experience leading teams and/or managing people (i.e. employees, contractors,) desired for leadership positions Demonstrated experience in preparing protocols, study reports, investigator brochures, and eCTD clinical summary documents, including regulatory submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) Medical writing experience for international regulatory submissions is a distinct advantage Experience with integrated electronic document management systems; Veeva Vault preferred Proficiency with Microsoft Office and use of electronic document templates Experience analyzing and selecting references based on scientific and regulatory relevance; familiarity with PubMed and/or other reference-gathering search tools Proficiency with Adobe Acrobat and Electronic Common Technical Document (eCTD) templates Familiarity with Good Clinical Practice (GCP) and applicable regulatory requirements and guidance documents, i.e., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
