The Manager, Medical Writing will be responsible for overseeing the authoring and/or directly authoring clinical and regulatory documents for submission to the FDA and other agencies, and to oversee and/or support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.The position may oversee the work of staff and contract writers, as well has having direct writing and editing responsibilities. The position will have a central role in developing infrastructure.
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 supportglobal 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 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 the 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
* 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
* Minimum of 3 years supervisory experience with in-house and/or contract medical writers
* 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
Minimum of a Bachelor's degree in life sciences field with pharmaceutical industry experience in safety, regulatory, or clinical areas is required. Transferrable skills in other clinical settings may be considered. Masters or doctorate degree qualification in life sciences preferred.
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.