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Gilead Senior Medical Writer (Non-Clinical) – Foster City August 14, 2008

Posted by synergistech in medical writer, peninsula, staff opp.
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Req Number: 98
Functional Area: Regulatory

Specific Responsibilities:
Provides a specialist writing resource to Research teams for developing preclinical regulatory documentation, with a primary focus on preclinical components for INDs and NDAs.

Essential Duties and Job Functions:

• Prepares a wide range of Regulatory documents, including CTD summaries, regulatory responses, Investigator’s Brochures, and Annual Updates to meet regulatory requirements and Gilead’s internal standards. Contributes to other ad hoc nonclinical regulatory writing activities as required.
• Acts as a primary contact point for Research teams on requirements for regulatory documents.
• Participates in submission teams providing advice/guidance on content development as well as defining document timelines for the overall submission plan.
• Works collaboratively with functional group contributors, ensuring all source information/data are appropriately reported in terms of accuracy, completeness, and scientific interpretation.

Knowledge, Experience and Skills:

• Demonstrated success in the preparation of regulatory documents, specifically IND documentation and CTD summaries for both nonclinical and clinical modules.
• Knowledgeable of regulatory document requirements/guidelines.
• Proven ability to facilitate issue resolution within multi-functional teams.
• Excellent regulatory writing and verbal communication skills.
• Specific pharmaceutical: Typically requires a BS degree and minimum of 10 years of relevant experience within clinical R&D or regulatory affairs pharmaceuticals/biotechnology, which includes 5 years of experience in a medical writing/clinical submissions environment directing/preparing documents for regulatory submissions.
• General scientific leveling guide: Typically requires a BS/BA degree and a minimum of 10 years of relevant experience, or an advanced degree and a minimum of 8 years of relevant experience.

To apply:

https://gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=98&CurrentPage=1

Gilead Senior Medical Writer – Foster City August 14, 2008

Posted by synergistech in medical writer, peninsula, staff opp.
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Req Number: 87

Specific Responsibilities:
Typically requires a BS/BA degree and minimum of 8 years of relevant experience within clinical R&D or regulatory affairs pharmaceuticals/biotechnology, which includes a minimum of 5 years in a medical writing/clinical submissions environment preparing documents for regulatory submissions.

Essential Duties and Job Functions:

• Prepares regulatory documents such as clinical study reports, Investigator’s Brochures and Annual Updates, in line with regulatory requirements and Gilead’s internal document standards.
• Medical writing activities at the level of single study reports and noncritical documents are performed without appreciable supervision. Additionally, is involved in the preparation of more complex regulatory documents (for example, CTD summaries, regulatory responses) with direction from Associate Director/Director level.
• Contributes to other non-regulatory medical writing activities as required. Depending on the complexity of the project, may participate in submission teams, providing advice/guidance for optimal presentation of data for achievement of document objectives.
• Leads document timeline/resource planning within the submission team. Works collaboratively with functional contributors (clinical, biometrics, virology, etc), ensuring that all source information/data are appropriately reported in terms of accuracy, completeness, and scientific interpretation, and that documents are completed in accordance with project timelines.
• Coordinates the compilation of final documents and appendices, coordinating clinical, biometrics, and regulatory contributions.
• Contributes to development work in relation to document standards, continuing MS Word template development, and other aspects of document management.
• Participates in group and somewhat-complex Company-wide process improvement and development initiatives.

Knowledge, Experience and Skills:

• Typically requires a BS/BA degree and a minimum 8 years of relevant experience, or an advanced degree and a minimum of 6 years of relevant experience.
• Requires a minimum of 5 years in a medical writing/clinical submissions environment preparing documents for regulatory submissions.
• Demonstrated success in the preparation of regulatory documents, particularly at the individual study report level.
• Highly developed and proven medical writing skills.
• Knowledge of regulatory document requirements/guidelines.
• Excellent verbal communication skills.
• Understanding of somewhat-complex document management, authoring, and publishing tools and their applicability for workflow efficiency.
• Well-developed computer skills, including proficiency in Word, PowerPoint, and Excel. Use of project management tools and graphics packages also desirable.

To apply:

https://gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=87&CurrentPage=1

BioMarin Pharmaceutical Sr. Medical Writer – Brisbane August 14, 2008

Posted by synergistech in medical writer, peninsula, staff opp.
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Job Code: 08-0082

At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

BioMarin is pleased to offer a comprehensive benefits program that extends beyond that commonly seen in the biotech industry. Currently, there are no out of pocket costs for eligible employees and their eligible dependents.

SUMMARY DESCRIPTION
The Senior Medical Writer applies advanced documentation planning and preparation and document project management skills to assist in the development, review, editing, and finalization of documents for regulatory submission and publications.

RESPONSIBILITIES

• In collaboration with key contributors, writes and edits assigned regulatory documents that conform to global regulatory submission and internal document standards.
• May collaborate with other writers or manage the writing effort of contract writer(s) to complete deliverables.
• Provides peer review, quality control, and editing support for regulatory documents and may also provide editorial or review support for other types of documents, such as manuscripts or presentations, CRFs, or study materials.
• Develops and maintains document templates and content guidelines that conform to document specifications and internal publishing requirements for regulatory filing.
• Develops and maintains work process documents, Style Guide, or other instruments relevant to development of regulatory documents.
• Assists in the preparation and distribution of documentation to the project team members.
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups within BioMetrics and document production teams.
• During project development, serves as clinical subteam specialist in clinical documentation.
• Ensures content and messages are consistent across regulatory documents within a project.
• Performs regulatory intelligence for information pertinent to Medical Writing and provide preliminary assessment of impact of new or modified regulations and guidances.
• Mentors writers.
• Other tasks as assigned.

Requirements
EDUCATION
Bachelor’s or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

EXPERIENCE
Fulfills one of the following:

• 5 to 8 years of experience as a medical writer in the pharmaceutical industry
• At least 8 years of experience in the pharmaceutical industry
• At least 10 years of medical or scientific writing experience as a fulltime and primary job responsibility

Clinical Studies

• Intermediate understanding of the drug development process (discovery to market), clinical study conduct, and clinical study data collection and basic understanding of database management, data integration, and generation of datasets.
• Intermediate applied knowledge of documentation required for the conduct of clinical studies, protocol design (including objectives, efficacy and safety endpoints procedures for collecting and reporting AEs and SAEs), and study results reporting.
• Direct experience with documentation for at least 3 phases of drug development. Medical Writing
• Advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
• Skilled in data interpretation from complex tabular and graphical clinical data presentations; able to draw conclusions and to enhance the interpretation based on related output.
• Ability to create complex tables as required.
• Intermediate to advanced applied knowledge of basic clinical laboratory tests.
• Advanced capabilities to research literature and interview subject matter experts to quickly gain familiarity with therapeutic area
• Advanced understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
• Intermediate understanding of biostatistical and clinical research concepts.
• Intermediate understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.
• Fully capable of writing high-quality documents that support corporate goals and objectives.
• Able to mentor others in all of the above skills and tasks. Computer/office Equipment Skills
• Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint and Adobe Acrobat; able to troubleshoot basic Word problems
• Intermediate skills with Visio, SigmaPlot or other graphic/flowchart software, MS Project, and document management software (ie, LiveLink, Documentum); able to mentor others in their use
• Experienced with scanners, printers, and copiers

Regulatory

• Advanced applied knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports) evidenced by ability to develop these documents in context of these requirements and guidances, development program plans, and organizational business needs.
• Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US and EMEA submissions.
• Intermediate to advanced applied knowledge of regulatory guidances associated with IND/NDA submissions Modules 2 and 5 in eCTD format and basic to intermediate applied knowledge of Modules 3 and 4, ISS/ISE, and IND Annual Reports.

Project Management

• Capable of working on multiple tasks and shifting priorities.
• Motivated and shows initiative; initiates appropriate action items and proposes workable solutions to document development team.
• Detail oriented.
• Advanced applied knowledge of the principles of tracking and accurately compiling reviewer comments.
• Advanced applied knowledge of planning, estimating writing resources, initiating, and managing standalone and simple dossier document review/development in a team setting leading to on-time delivery of documents that meet company goals and objectives and satisfy regulatory requirements.
• Advanced applied capabilities of managing business partners through document review cycles.
• Proactively tracks status of document projects assigned and provide status updates to Medical Writing management.

Communication

• Capable of well organized, concise and clear written and verbal communication
• Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements
• Effective at explaining writing principles to a varied audience both in individual and group settings; excellent general presentation skills
• Ability to develop and maintain good working relationships with subject matter experts and other team members
• Ability to contribute substantively and diplomatically in document review meetings

To apply:

http://careers.clinicaspace.com/Jobs/Public/DirectApplyName.aspx?JOB_ID=244911&COMPANY_ID=247841&PREFIX=cs.&update=true