Senior Medical Writing Director

3 weeks ago

Alameda, United States Exelixis Full time

SUMMARY/JOB PURPOSE:

Writes and edits various documents to support Product Development. Such documents may include clinical study reports (CSRs), common technical document (CTD) summaries for submission to regulatory agencies, protocols, Investigator Brochures, literature reviews, study manuals, and standard operating procedures (SOPs). Assembles CSR and CTD summary appendices and narratives. Requires knowledge of company policies and technical platforms, product areas, current developments, and keeping abreast of current literature.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Writes and edits CSRs, CTD summaries, protocols, investigators brochures, and other clinical trial documentation as necessary for submission to regulatory agencies and other stakeholders or for in-company use.
  • Proposes and manages timelines for document preparation and review.
  • Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed.
  • Integrates various sources of information into a uniform style and language for regulatory compliance.
  • Assembles CSR and CTD summary appendices and narratives.
  • Serves as the MW expert on regular and ad hoc study, program, or project teams.
  • Leads and manages teams of medical writers in complex projects by providing guidance based on organizational goals and company policy, with responsibility for results.
  • Guides and advises Medical Writing contributors as a function of program representation. This responsibility may include document review.
  • Performs quality checks of documents prepared by other medical writers as needed.
  • Proposes opportunities for process improvement and leads projects to enhance efficiency and optimize the use of resources.
  • Other duties as needed.

SUPERVISORY RESPONSIBILITIES:

  • No direct reports.
  • Provides asset-level strategic guidance to study-level MW representatives.
  • Mentors less experienced medical writers.
  • Supports and directs the work of contract medical writers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

  • BS/BA degree in related discipline and a minimum of fifteen years of related experience; or,
  • MS/MA degree in related discipline and a minimum of thirteen years of related experience; or,
  • PhD in related discipline and a minimum of twelve years of related experience; or,
  • Equivalent combination of education and experience.
  • May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

  • Experience in Biotech/Pharmaceutical industry required.
  • Nine to eleven years of medical writing or equivalent writing experience in the pharmaceutical industry.
  • Experience and significant participation in preparation of documents for regulatory submissions (e.g., clinical protocols, INDs, NDAs, BLAs, CTDs).
  • Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications.

Knowledge/Skills:

  • Familiarity with therapeutic area of oncology is essential.
  • Good/general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.
  • Excellent writing ability with strong attention to detail.
  • Proficient in Windows suite.
  • Ability to independently develop high-quality complex documents.
  • Familiarity with document management systems is essential.
  • Directs a variety of complicated tasks with a wide degree of strategic flair (e.g., by direct contact with personnel at other organizations), independence, creativity, and latitude.
  • Identifies and implements methods and procedures to achieve results.
  • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
  • Has good general knowledge of other related disciplines.
  • Has good timeline development and management skills.
  • Applies strong analytical and business communication skills.

JOB COMPLEXITY:

  • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. High degree of independent work and strategic flair required.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.
  • Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  • Networks with key contacts outside own area of expertise.

WORKING CONDITIONS:

  • Environment: primarily working indoors, performing clerical work.

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.

#J-18808-Ljbffr

  • Health Services Director

    3 weeks ago

    Alameda, United States Oakmont Senior Living Full time

    Health Services Director - LVN Schedule: Sunday - Thursday Oakmont of Mariner Point is a premier senior living community situated on a beautifully landscaped campus. Managed by Oakmont Management Group,we provide exceptional quality, comfort, and care with five-star services and amenities. Residents enjoy a rewarding lifestyle with individualized...

  • Medication Technician

    4 weeks ago

    Alameda, United States Oakmont Senior Living Full time

    Position: Medication Technician FT - AM SHIFT Pay Range: $18.75 - $21.25 INSERT COMMUNITY NAME is a premier senior living community situated on a beautifully landscaped campus. Managed by Oakmont Management Group,we provide exceptional quality, comfort, and care with five-star services and amenities. Residents enjoy a rewarding lifestyle with...

  • Activity Director

    1 month ago

    Alameda, California, United States Oakmont Management Group Full time

    Job Summary:We are seeking a highly motivated and creative Activity Director to join our team at Oakmont of Mariner Point. As a key member of our community, you will be responsible for designing and implementing engaging activities that promote resident participation and a sense of community.Key Responsibilities:• Develop and lead high-quality activities,...

  • Site Director at Ruby Bridges Elementary

    19 hours ago

    Alameda, United States KinderCare Education Full time

    Futures start here. Where first steps, new friendships, and confident learners are born. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award, we offer a variety of early education and child care options for families. We pave the way for their lifelong learning journey...

  • Senior Electrical Engineer(Medical device)

    3 weeks ago

    Alameda, United States INTELLECTT INC Full time

    Role: Senior Electrical Engineer I Location: Alameda, CA - 94502 Duration: 12 Months (Possible extension) Skills Looking For: Component Engineer; senior level role. Lead role that works independently in qualifying alternate electronic and mechanical components for medical products. Will use independent judgment to review technical specification sheets...

  • Senior Electrical Engineer(Medical device)

    3 weeks ago

    Alameda, United States INTELLECTT INC Full time

    Role: Senior Electrical Engineer I Location: Alameda, CA - 94502 Duration: 12 Months (Possible extension) Skills Looking For: Component Engineer; senior level role. Lead role that works independently in qualifying alternate electronic and mechanical components for medical products. Will use independent judgment to review technical specification sheets...

  • Senior Electrical Engineer(Medical device)

    4 weeks ago

    Alameda, United States Intellectt Inc Full time

    Role: Senior Electrical Engineer ILocation: Alameda, CA - 94502Duration: 12 Months (Possible extension)Skills Looking For: Component Engineer; senior level role.Lead role that works independently in qualifying alternate electronic and mechanical components for medical products. Will use independent judgment to review technical specification sheets based on...

  • Assistant Director of Nurses

    1 month ago

    Alameda, United States Alameda Healthcare & Wellness Center Full time

    POSITION DESCRIPTION:A licensed professional nurse immediately under the Director of Nurses. The Assistant Director of Nurses is to assist the Director as instructed and has the authority of the Director of carrying out given tasks or areas of supervision in the Director’s absence.QUALIFICATIONS•...

  • Medical Writer

    3 weeks ago

    Alameda, United States Oxford Global Resources Full time

    Summary: The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical...

  • Medical Writer

    3 weeks ago

    Alameda, United States Oxford Global Resources Full time

    Summary: The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical...

  • Bioanalysis Director

    4 weeks ago

    Alameda, United States Exelixis Full time

    SUMMARY/JOB PURPOSE: The Bioanalysis Director (BD) will manage GxP-compliance in bioanalytical work for pharmacokinetic (PK), anti-drug antibodies (ADA), and biomarkers in support of nonclinical and clinical studies. BD will manage CRO-outsourced bioanalysis for small molecules and biologics and provide project management support for external and internal...

  • Senior Infrastructure Engineer

    3 months ago

    Alameda, United States IT Solutions Inc Full time

    Role: Senior Infrastructure EngineerLocation: Alameda, CA - Onsite 5 days/weekLevel: Senior (Min experience – 11+yrs IT, 6+ years domain)Job Description: This position has responsibility for all aspects of design, implementation, documentation, and operational support of current and new corporate systems. This individual will be an integral subject-matter...

  • Sales Strategy

    2 weeks ago

    Alameda, United States TerViva Full time

    Job Title: Sales Strategy & Operations Manager Reports to: Director of Sales Strategy & Operations Location: Alameda, CA Founded in 2010, Terviva is an agriculture and biotech startup commercializing sustainable biofuels and food ingredients derived from pongamia. Pongamia is a leguminous, native-to-Asia “super tree,” lauded for its carbon-storing and...

  • Sales Strategy

    2 weeks ago

    Alameda, United States TerViva Full time

    Job Title: Sales Strategy & Operations Manager Reports to: Director of Sales Strategy & Operations Location: Alameda, CA Founded in 2010, Terviva is an agriculture and biotech startup commercializing sustainable biofuels and food ingredients derived from pongamia. Pongamia is a leguminous, native-to-Asia “super tree,” lauded for its carbon-storing and...

  • Senior Quality Assurance Technical Manager

    1 month ago

    Alameda, California, United States Planet Pharma Full time

    Job Title: Senior Quality Assurance Technical ManagerJob Summary:This position is responsible for executing assigned tasks, including applying Quality tools and metrics to drive continuous improvement across a variety of systems and projects.The successful candidate will generate feasible solutions as a Subject Matter Expert (SME) and partner with key...

  • Credentialing Coordinator

    3 months ago

    Alameda, United States Alameda Alliance Full time

    PRINCIPAL RESPONSIBILITIES : The Credentialing Coordinator works under the supervision of the Manager, Peer Review and Credentialing and assists in all aspects of the Credentialing department functions. The Credentialing Coordinator is responsible for coordinating, monitoring and maintaining the credentialing and recredentialing processes of health care...

  • Sales Strategy

    1 week ago

    Alameda, United States TerViva Full time

    Job Title: Sales Strategy & Operations ManagerReports to: Director of Sales Strategy & OperationsLocation: Alameda, CA Founded in 2010, Terviva is an agriculture and biotech startup commercializing sustainable biofuels and food ingredients derived from pongamia. Pongamia is a leguminous, native-to-Asia "super tree," lauded for its carbon-storing and...

  • Sales Strategy

    4 weeks ago

    Alameda, United States TerViva Full time

    Job Title: Sales Strategy & Operations Manager Reports to: Director of Sales Strategy & Operations Location: Alameda, CA Founded in 2010, Terviva is an agriculture and biotech startup commercializing sustainable biofuels and food ingredients derived from pongamia. Pongamia is a leguminous, native-to-Asia “super tree,” lauded for its carbon-storing and...

  • Sales Strategy

    4 weeks ago

    Alameda, United States TerViva Full time

    Job Title: Sales Strategy & Operations Manager Reports to: Director of Sales Strategy & Operations Location: Alameda, CA Founded in 2010, Terviva is an agriculture and biotech startup commercializing sustainable biofuels and food ingredients derived from pongamia. Pongamia is a leguminous, native-to-Asia “super tree,” lauded for its carbon-storing and...

  • Dialysis Social Worker

    7 days ago

    Alameda, United States Fresenius Medical Care Full time

    POSITION FEATURES:Bilingual preferredProvisional license acceptedTwo locations in Albuquerque (mileage provided for second clinic)About this role:As a Social Worker with Fresenius Medical Care, you will provide psychosocial services for our dialysis clinic patients. You will work with the health care team to promote positive adjustment, rehabilitation, and...