Sr. Medical Writer in Seattle, WA

$80K - $100K(Ladders Estimates)

Seattle Genetics   •  

Seattle, WA 98160

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 44 days ago

Summary:

The Senior Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.Responsibilities:

Includes but not limited to:

Prepares Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), and other documents to support global product development

Leads the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings in collaboration with clinical study teams

Leads the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals including direct collaboration with internal and external authors

Under limited supervision may coordinate/lead the activities of multiple contributors to medical writing projects/submissions

Participates in the strategic publication planning process and implementation of publication plans, including working with author groups to develop and author manuscripts, abstracts, and presentations for scientific congresses

Provides project teams with expertise and strategic guidance on analysis and presentation of

clinical and safety data and on benefit-risk assessment in documents

Organizes, conducts, and leads cross-functional document development meetings

Develops the strategy for document preparation and manages the overall document development process including timelines, document reviews, and approvals in adherence with company standard operating procedures and regulatory guidance, including the escalation of issues when required

Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problem solving ability

Routinely engages clinical research and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences

Represents medical writing on multiple study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments

Lead and/or participate in development of medical writing processes and infrastructure development

Contributes to clinical trial registry postings and results disclosures on US and EU platforms

May coordinate the activity or serve as internal contact for contract medical writers and other providers

Develops and implements templates, style standards, and standard operating procedures to ensure consistent and high quality deliverables

Qualifications:

Minimum of 5 (MS/PhD) to 8 (BA/BS) years of experience in the biopharmaceutical industry with 3 years (MS/PhD) to 5 years (BA/BS) direct medical writing experience; post-doctoral research may be considered in lieu of 1-2 years industry experience for doctoral level candidates

Expertise in preparing clinical regulatory documents and scientific publications is crucial

Adept at engaging with senior management and executives

Prior NDA/BLA/MAA submission experience, including eCTD, required

Excellent written and verbal communication skills

Expert ability to interpret and present statistical and clinical data to varied audiences

Advanced knowledge in therapeutic area

Ability to influence and reach compromises cross functionally to produce a quality document

Has a thorough understanding of other cross-functional departments/disciplines and how they contribute to the drug development process

Expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred

Advanced knowledge of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process

Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment

Flexible with the ability to learn new medical/clinical therapeutic areas and/or indications quickly

Familiarity with clinical trial transparency requirements, including ClinicalTrials.gov and EudraCT standards, preferred

Background in oncology drug development is a plus.



Valid Through: 2019-10-29