Seagen

Associate Director Medical Writing

Description

Summary

The Associate Director, Medical Writing will be expected to directly supervise both contract and staff writers and manage medical writing deliverables associated with a program(s). The Associate Director, Medical Writing will also be responsible for independently authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to lead other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.

The medical writing program leads will oversee medical writing deliverables and staff at the program level. Late stage program leads will oversee these activities and staff for one program that is either an approved product with significant ongoing activity and expansion or a product that is moving towards or already has a registrational study that is ongoing. The early stage program lead will oversee programs in which an IND is in progress to conduct a first-in-human study and/or has ongoing studies that are not yet registration. As a program moves from early stage to late stage a medical writing program lead and supporting writers will be assigned to that program. The medical writing program lead is a manager or above and reports into senior medical writing leadership.

Principal Responsibilities

• Leads the activities of multiple contributors to medical writing projects/submissions, including IND applications and NDA/BLA/MAAs
• Manages medical writing activities across programs, studies, and projects
• Reviews and provides editorial input on clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other regulatory documents
• Ensures that documents created and edited by the medical writing function are in compliance with GCP, ICH guidelines, and eCTD requirements; and adhere to corporate SOPs and style guide
• Participates in the strategic publication planning process and implementation of publication plans
• Directly supervises junior writers and/or other medical writing staff and contract writers
• Serves as mentor for medical writers and senior medical writers
• Develops and implements templates, style standards, and standard operating procedures to ensure consistent and high-quality deliverables

Program Lead Responsibilities:

• Member of the medical writing leadership team
• Oversees the development of all clinical/regulatory documents and publications for program(s)
• Forecasts resourcing needs and works with medical writing senior leadership to secure additional resources when needed
• Tracks status of all ongoing deliverables with the program to identify potential risks to quality and/or timeliness
• Addresses potential issues with direct intervention or though escalation to line management
• Leads group of core regulatory and publication writers for program
• Supervises FTE staff writers assigned to program
• Maintains direct line of communication with full writing team assigned to program (FTE staff, ICs, and FSPs)
• Ensures full writing team (FTE staff, ICs, and FSPs) is properly trained on Seagen medical writing processes and standards
• Represents medical writing on program-level teams (e.g., GPTs), providing expertise and strategic guidance on document preparation and the analysis and presentation of clinical and safety data in documents
• Routinely engages program-level leads of relevant disciplines (e.g., GRL, GDL) to maintain strategic alignment between functions and to foster collaboration to proactively address issues before they occur
• Develops and implements program-specific templates and processes to ensure consistent and high-quality medical writing deliverable

Required Qualifications:

• Minimum of 10 years of experience in the biopharmaceutical industry, with 7 years of direct medical writing experience; advanced degree(s)/academic research/transferable skills may be considered in lieu of industry experience
• 2-3 years supervisory experience
• BA/BS

Preferred Qualifications:

• Masters or doctorate degree in life sciences
• Excellent written and verbal communication skills with the ability to interpret and present scientific data
• Ability to work cross-functionally
• Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat
• Awareness 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 with minimal supervision

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.

Seagen 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/26/2021