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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

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SUMMARY/JOB PURPOSE:

Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex crossfunctional documents and reports as needed.

ESSENTIAL DUTIES/RESPONSIBILITIES:

Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience.
Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy.
Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and intext tables.
Assigns and supervises partner regulatory editors for all document tasks unrelated to writing.
Proposes and manages timelines for the document development process from initiation through approval.
Oversees the assembly of appendices for regulatory submission documents as needed.
Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams.
Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results.
Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members.
Contributes to SOP and work instruction development and review for the Regulatory Science Communications team.

Other duties as needed.

SUPERVISORY RESPONSIBILITIES:

No direct reports.
Supervises work of junior writers and regulatory editors on document tasks.
May direct and review the work of contract writers as needed.
May mentor less experienced writers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

BS/BA degree in related discipline and a minimum of eleven years of related experience including industry; or,
MS/MA degree in related discipline and a minimum of nine years of related experience including industry; or,
PhD in related discipline and a minimum of five years of related experience including industry; or
Equivalent combination of education and experience.
Active AMWA member with certificate or certification preferred; BELS certification a plus.

Experience:

Experience in Biotech/Pharmaceutical industry preferred.
Prior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industry.
Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs).
Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications.
Familiarity with therapeutic area of oncology.
Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards.
Advanced knowledge of AMA style, medical terminology, and clinical data analysis.

Knowledge, Skills and Abilities:

Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work.
Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work.
Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues.
Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.
Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships.
Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.
Capable of managing the execution of multiple tasks.
Ensures appropriate prioritization and execution for area of responsibility.
Proactively anticipates, prioritizes and resolves task-related challenges.
Designs and implements solutions to address task-related challenges, taking into consideration the broader impact.

Work Environment/Physical Demands:

Environment: primarily working indoors.
Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

#LI-MB1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $148,500 - $209,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. 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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Required

Preferred

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SUMMARY/JOB PURPOSE:

Leads content development for various re...","Associate Regulatory (Medical Writing) Scientific Communications Director",["B","1855869227"],"4 months ago","/jobs/1855869227-associate-regulatory-medical-writing-scientific-communications-director","Associate Regulatory (Medical Writing) Scientific Communications ...","/jobs?keyword=Associate+Regulatory+%28Medical+Writing%29+Scientific+Communications+...",{"_429":428,"_434":535,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":536,"_431":432,"_433":194,"_454":453,"_442":443,"_425":537,"_455":456,"_430":118,"_476":538,"_460":539,"_478":536,"_479":443,"_481":482,"_483":484,"_485":540},["D",1771372800000],"Associate Digital Marketing Director - Web/Email",["B","2619523387"],"1 days ago","/jobs/2619523387-associate-digital-marketing-director-web-email","/jobs?keyword=Associate+Digital+Marketing+Director+-+Web%2FEmail",{"_429":428,"_434":542,"_452":453,"_444":543,"_243":544,"_441":545,"_427":428,"_111":546,"_431":194,"_433":194,"_454":453,"_442":443,"_425":547,"_455":548,"_430":115,"_476":549,"_460":550,"_478":551,"_479":443,"_481":552,"_483":484,"_485":553},["D",1771452943000],"Exelixis, Inc.","Associate Technical Accounting Director page is loaded## Associate Technical Accounting Directorlocations: Alameda, CAtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR6339**SUMMARY/JOB PURPOSE:**This person will be a key member of the Accounting department to supplement the Company’s Technical Accounting and SEC reporting team. This person will have the primary responsibility for technical accounting guidance and SEC reporting as well as provide project management as needed at this growing biotechnology company. This person must display an in-depth knowledge of U.S. Generally Accepted Accounting Principles, SEC reporting and Sarbanes Oxley compliance and be able to apply them to all aspects of the Company’s accounting needs. This person must display a good understanding of revenue accounting (ASC 606, ASC 808), lease accounting (ASC 842), variable interest entities and Stock-based compensation (ASC 718) and display proficiency in the quarter and year end process for SEC reporting. This person will report to the Sr. Director, Technical Accounting and work closely with the Director of SEC reporting, Accounting, Tax, FP&A, Business Development, Legal and other members of the organization as needed as we continue to encounter complicated accounting issues. This person will also interface with outside technical advisors and auditors to ensure proper accounting on all current and emerging accounting issues to ensure the Company’s conclusions on technical issues are appropriately documented and the books and records appropriately reflect the Company’s financial position and results of operations. This person will also ensure the Company’s accounting policies are appropriately updated as the Company continues to grow.**Essential Duties And Responsibilities:**•Key resource within the Company for technical accounting guidance; •Apply technical guidance to business transactions; •Work closely with Accounting, Finance, Legal and Business Development teams; •Technical interface between the Company and outside advisors and auditors; •Perform accounting research and draft technical memos; •Ensure the accounting policies are up-to-date; •Assist with SEC reporting as needed; and, •Project manage as needed for company initiatives.**Supervisory Responsibilities:**•None**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:****Education/Experience:**•BS/BA degree in Accounting; •Certified Public Accountant (CPA);**Experience/The Ideal for Successful Entry into Job:**•7+ years of experience with Big 4 and work experience at a public company;**Knowledge/Skills:**•In-depth knowledge of US GAAP; •In-depth knowledge of SEC reporting; •Strong interpersonal communication skills, including excellent verbal and written communications; •Detail and Service oriented; and, •Proficient with Microsoft Excel, Word & Power Point**JOB COMPLEXITY:****Working Conditions:**•Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; •May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors; •Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results; •Networks with key contacts outside own area of expertise.#LI-EZ1*If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!*### ### Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $163,000 - $231,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.### **DISCLAIMER** The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. 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.***We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.***Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.\n#J-18808-Ljbffr","Associate Technical Accounting Director page is loaded## Associate Technical Accounting Directorlocations: Alameda, CAtime type: Full timeposte...","Associate Technical Accounting Director Job at Exelixis, Inc. in Alameda",["B","1980829736"],"Work at Exelixis, Inc.","2 hours ago","/jobs/1980829736-associate-technical-accounting-director-job-at-exelixis-inc-in-alameda","Associate Technical Accounting Director Job at Exelixis, Inc. in ...","/jobs?keyword=Exelixis%2C+Inc.","/jobs?keyword=Associate+Technical+Accounting+Director+Job+at+Exelixis%2C+Inc.+in+...","actionData","errors"]