Senior Manager, Medical Writing
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com]
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Medical Writing (Psychiatry/Neurology). A Senior Manager, Medical Writing is accountable for the timely delivery of high-quality regulatory submission documents. A Senior Manager, Medical Writing will lead the medical writing activities for one or more therapeutic areas or clinical development programs. A Senior Manager, Medical Writing develops strategic medical writing plans in order to meet clinical program objectives. A Senior Manager, Medical Writing provides management and oversight of medical writing staff to ensure regulatory submission documents are developed in accordance with medical writing plans.
Job Duties and Responsibilities
Develop strategic medical writing plans in accordance program and/or project objectives. Plans are developed in accord with applicable guidelines (ICH, CFR, etc.) and with adherence to SMPA templates and SOPs.
Determine resource requirements to meet regulatory submission document deliverable milestones and timelines in accordance with medical writing plans.
Manage and provide mentorship and guidance to Medical Writing staff (internal/external) to ensure document development activities are performed in accordance with medical writing plans.
Provide senior level review of regulatory submission documents prepared by Medical Writing staff (internal/external).
Author and review documents for regulatory submissions (protocols, investigator brochures, clinical study reports, and IND and NDA summary documents) in support of the clinical development lifecycle and program goals for one or more CNS clinical development programs.
Drive document strategies and messages to relevant subject matter experts to ensure appropriate, factual and concise presentation of assigned documents.
Key Core Competencies
Excellent problem-solving skills.
Ability to work effectively on cross-functional teams.
Excellent communication skills.
Demonstrated ability to understand broad concepts and translate these into medical writing strategy.
Demonstrated coaching skills to develop individual medical writers.
Education and Experience
Bachelor’s degree required; advanced degree (Master’s) in science desired.
Minimum 8 – 12 (w/o Master’s) or 6 – 8 years (with Master’s) years of relevant experience in biotech or pharmaceutical industry.
Medical writing experience, including writing and review of documents to support the clinical development life-cycle from IND to NDA and beyond.
Experience representing medical writing on cross-functional teams.
The base salary range for this role is $145,000.00 to $181,0000.00. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data:All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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