Job Description

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 cross?functional documents and reports as needed.
ESSENTIAL DUTIES AND 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 in?text 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 Communication 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 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/Experience:

• BS/BA degree in related discipline and a minimum of nine years of related experience including industry; or,
• MS/MA degree in related discipline and a minimum of seven years of related experience including industry; or,
• PhD in related discipline and a minimum of two 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/The Ideal for Successful Entry into Job:

• 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:

• Manages time and resources to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
• Applies knowledge of the regulatory framework and industry practices to complete routine 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 small groups of departmental colleagues.
• Good interpersonal skills and emerging ability to accommodate differing views to support the development of an agreed upon resolution.
• Works collaboratively with team members to achieve common objectives. Engages internal stakeholders to establish collaborative relationships.
• Applies knowledge of organizational objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
• Leads self by managing and executing own work. Acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

JOB COMPLEXITY:

• Capable of following predefined procedures for specific tasks.
• Capable of anticipating, identifying, prioritizing and resolving task-related challenges.
• Identifies and escalates issues that may have a broader impact.
• Implements solutions to address any task-related challenges.

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work.

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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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $137,500 - $195,500 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.

Skills Required