Seagen

Pharmacovigilence Medical Writer II

Development - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Position Summary:

The Pharmacovigilence Medical Writer II will be responsible for collaboratively authoring and revising key drug safety-focused documents and reports for submission to the FDA and other regulatory health agencies. This role will work closely with medical and safety colleagues to prepare accurate and concise analyses of safety data to support development of new treatments as well as support post-marketing safety activities for approved agents.

Principal Responsibilities:

Includes but not limited to:

• Lead the authoring and editing of periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, in collaboration with Safety Evaluation and Risk Management (SERM), safety scientists, and medical colleagues
• Lead the authoring and editing of RMPs and REMS in collaboration with Safety Evaluation and Risk Management (SERM), safety scientists, and medical colleagues
• In collaboration with cross-functional teams, contribute safety information to NDA annual reports and Information Requests as needed, both internally and externally
• Understand relationships and dependencies between documents and ensure consistency in information presented in aggregate reports and RMPs with other program documents (e.g., IBs, product labeling, CTD)
• In conjunction with leading collaborative authoring, the Sr. PV Medical Writer will be responsible for project management, including but not limited to:
• Developing timelines for team endorsement
• Setting up and effectively leading comment resolution meetings
• Working with the project team to resolve comments or gain team consensus
• Leading the document through authoring, review, and medical writing QC
• In conjunction with cross-functional team, the Sr. PV Medical Writer will translate regulatory guidance and lead template development for PV medical writing templates
• Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
• Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission
• Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents
• Represents medical writing on project teams and contributes to program strategy, through collaborative engagement with cross-functional personnel
• Draft other safety medical writing deliverables as needed

Required Qualifications:

• 3-5 years biopharmaceutical industry experience in safety, regulatory, clinical areas, with 3 years of direct medical writing experience; advanced degree(s)/academic research/transferable skills may be considered in lieu of industry experience
• BA/BS degree 

Preferred Qualifications:

• Experience with aggregate reports and RMPs
• Collaborative writing experience
• Excellent project management, written and verbal communication skills, with the ability to interpret and present information to varied audiences
• Ability to coordinate and prioritize multiple projects in a fast-paced matrix environment with limited to little supervision
• Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process
• Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat
• Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical industry deliverables
• Knowledge of drug safety/pharmacovigilance practices and tools
• Background in oncology drug development is a plus
• Master’s or doctorate degree qualification in life sciences or public health
• Interpersonal skills that promote a collaborative and productive team environment

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.

The hiring pay range for this position is $105,000 - $136,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/17/2023