CITY OF SAN ELIZARIO
Director, Medical Writing
CITY OF SAN ELIZARIO, San Francisco, California, United States, 94199
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Clinical DevelopmentJob Type:
Full TimeWorkplace Type:
HybridDirector, Medical Writing
Company Description
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.Why Work With UsNothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.Work Requirement We are open for this role to be based out of our following offices: Redwood City, CA, Vancouver, BC, Bellevue, WA, Singapore, and Dublin. This role will be hybrid with a minimum of 3 days per week onsite.Key Responsibilities
Liaises with research scientists to outline, write and coordinate review and editing of medical writing deliverables and serves as Medical Writer on project teams.Prepares, edits and finalizes documents primarily related to INDs, early and late phase clinical oncology research including, but not limited to:
Nonclinical pharmacology reportsClinical study protocolsInformed consent formsClinical study reportsAdverse event narrativesInvestigator’s brochuresDevelopment Safety Update ReportsInvestigational new drug application overviews and summariesPublications (manuscripts, abstracts, oral presentations, and poster presentations)
Leads the planning and execution of MW projects, including resource allocation, timeline management, and budget oversight.Oversees MW activities outsourced to the global CROs, including reviewing requests for proposals, budgets, scope of work, and final contracts.Develops and optimizes departmental infrastructure, process documents, templates, and trackers in collaboration with other functional areas.Collaborate with Biometrics department in developing study-specific and standard tables, listings, and figures (TLFs) as well as defining the scope of outputs required for various documents, including Investigator’s brochures, clinical study reports, and interim and final publications.Reviews statistical analysis plans while considering the study protocol and future clinical study report.Collaborate with data management in development of case report forms and participate in data reviews.Adheres to established regulatory standards including, but not limited to, ICH and FDA guidelines, company standard operating procedures, work practices and approved templates.Completes medical writing projects on-time and on-budget.Reviews all writing of nonclinical and clinical reports to ensure consistency, accuracy and professional layout.Serves as a reviewer for internally and externally prepared documents.Directs the copy editing and proofreading process for documentation in accordance with corporate standard operating procedures and work practices.Provides training to other internal writers and cross-functional team members on company document preparation processes and systems.Leads through example to establish an environment fostering effective and collaborative working relationships.Effectively builds regular and proactive communication among department staff.Monitors, tracks and reports program status to key stakeholders including senior management.
Education and Experience
MS/MA or higher advanced degree with a minimum of 12 years related experience or an equivalent combination of education and experience.Skills and AbilitiesExpert interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.Able to think and act strategically, anticipate road-blocks and map out next steps.Demonstrated high level of integrity and ethics.Deep understanding of scientific methods, science and medical terminology in the area of oncology. Knowledge in the fields of autoimmune diseases and neurology, an asset.Previous experience preparing submissions for oncology drugs using antibodies and antibody drug conjugates.Pharmaceutical research and development experience beyond medical writing.Deep experience performing literature searches and preparing grant applications, abstracts, manuscripts, annual reports and press releases.Technical expertise in nonclinical and clinical oncology studies.Exceptional oral and written communications skills and the ability to write clearly and concisely. Extensive knowledge of English grammar.Excellent attention to detail and a methodical, diligent approach to proofreading, ensuring consistency in style, grammar and punctuation.Advanced experience and skill in document layout and formatting.Deep understanding of regulatory standards, but not limited to FDA and ICH regulations and guidelines.Expert knowledge with MS Office, Visio and Adobe Acrobat, including templates for authoring protocols and clinical study reports.Familiarity with electronic Common Technical Document (eCTD), a plusAbility to travel, as required (up to 20%).
Total RewardsWe offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.The US base salary range for this full time position is $180,000 - $276,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits.Industry leading vacation and paid time offExcellent health and wellness benefitsZymelife health and wellness benefitsPaid time off to volunteer in your communityMatching country specific pension savings programEmployee Share Purchase ProgramEmployee Equity ProgramAll qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.NOTE TO AGENCIES:
Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.Date:
Aug 23, 2024
Nearest Major Market:
San FranciscoNearest Secondary Market:
Oakland
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Clinical DevelopmentJob Type:
Full TimeWorkplace Type:
HybridDirector, Medical Writing
Company Description
Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV.Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.Why Work With UsNothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and the Bay Area.Work Requirement We are open for this role to be based out of our following offices: Redwood City, CA, Vancouver, BC, Bellevue, WA, Singapore, and Dublin. This role will be hybrid with a minimum of 3 days per week onsite.Key Responsibilities
Liaises with research scientists to outline, write and coordinate review and editing of medical writing deliverables and serves as Medical Writer on project teams.Prepares, edits and finalizes documents primarily related to INDs, early and late phase clinical oncology research including, but not limited to:
Nonclinical pharmacology reportsClinical study protocolsInformed consent formsClinical study reportsAdverse event narrativesInvestigator’s brochuresDevelopment Safety Update ReportsInvestigational new drug application overviews and summariesPublications (manuscripts, abstracts, oral presentations, and poster presentations)
Leads the planning and execution of MW projects, including resource allocation, timeline management, and budget oversight.Oversees MW activities outsourced to the global CROs, including reviewing requests for proposals, budgets, scope of work, and final contracts.Develops and optimizes departmental infrastructure, process documents, templates, and trackers in collaboration with other functional areas.Collaborate with Biometrics department in developing study-specific and standard tables, listings, and figures (TLFs) as well as defining the scope of outputs required for various documents, including Investigator’s brochures, clinical study reports, and interim and final publications.Reviews statistical analysis plans while considering the study protocol and future clinical study report.Collaborate with data management in development of case report forms and participate in data reviews.Adheres to established regulatory standards including, but not limited to, ICH and FDA guidelines, company standard operating procedures, work practices and approved templates.Completes medical writing projects on-time and on-budget.Reviews all writing of nonclinical and clinical reports to ensure consistency, accuracy and professional layout.Serves as a reviewer for internally and externally prepared documents.Directs the copy editing and proofreading process for documentation in accordance with corporate standard operating procedures and work practices.Provides training to other internal writers and cross-functional team members on company document preparation processes and systems.Leads through example to establish an environment fostering effective and collaborative working relationships.Effectively builds regular and proactive communication among department staff.Monitors, tracks and reports program status to key stakeholders including senior management.
Education and Experience
MS/MA or higher advanced degree with a minimum of 12 years related experience or an equivalent combination of education and experience.Skills and AbilitiesExpert interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.Able to think and act strategically, anticipate road-blocks and map out next steps.Demonstrated high level of integrity and ethics.Deep understanding of scientific methods, science and medical terminology in the area of oncology. Knowledge in the fields of autoimmune diseases and neurology, an asset.Previous experience preparing submissions for oncology drugs using antibodies and antibody drug conjugates.Pharmaceutical research and development experience beyond medical writing.Deep experience performing literature searches and preparing grant applications, abstracts, manuscripts, annual reports and press releases.Technical expertise in nonclinical and clinical oncology studies.Exceptional oral and written communications skills and the ability to write clearly and concisely. Extensive knowledge of English grammar.Excellent attention to detail and a methodical, diligent approach to proofreading, ensuring consistency in style, grammar and punctuation.Advanced experience and skill in document layout and formatting.Deep understanding of regulatory standards, but not limited to FDA and ICH regulations and guidelines.Expert knowledge with MS Office, Visio and Adobe Acrobat, including templates for authoring protocols and clinical study reports.Familiarity with electronic Common Technical Document (eCTD), a plusAbility to travel, as required (up to 20%).
Total RewardsWe offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.The US base salary range for this full time position is $180,000 - $276,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.
The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits.Industry leading vacation and paid time offExcellent health and wellness benefitsZymelife health and wellness benefitsPaid time off to volunteer in your communityMatching country specific pension savings programEmployee Share Purchase ProgramEmployee Equity ProgramAll qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.NOTE TO AGENCIES:
Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.Date:
Aug 23, 2024
Nearest Major Market:
San FranciscoNearest Secondary Market:
Oakland
#J-18808-Ljbffr