Sunovion Senior Manager, Medical Writing in Marlborough, Massachusetts
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 ID: 6582BR
Department: Research & Development
Location: Marlborough, MA
Job Type: Full-time
Summary of Responsibilities: 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.
Essential Functions: •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 Sunovion 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 clinical development programs.
•Drive document strategies and messages to relevant subject matter experts to ensure appropriate, factual and concise presentation of assigned documents.
Minimum Education Requirements: Bachelors
Experience Required: 5 - 7 Years
Knowledge & Skills (General and Technical): Knowledge and skills indicate the education level, previous experience, specific knowledge, skills and abilities necessary to meet the minimum requirements for this position.
Education level and/or relevant experience(s):
•Bachelor’s degree required; advanced degree (Master’s or PhD) in science desired.
•5-7 years medical writing experience, including management/mentorship of medical writers (either internal or external writers).
•Experience representing medical writing on cross-functional teams.
•Experience develop medical writing strategies and plans to support the clinical development life-cycle from IND to NDA and beyond.
Knowledge and skills (general and technical):
•Strong interpersonal and teamwork skills.
•Excellent oral and written communication skills.
•Strong analytical and organization skills and a high attention to detail.
•Strong working knowledge of Adobe PDF, MS WORD, EXCEL, PowerPoint, and Project.
•Experience with automated document templates and AMA style guide.
•Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures.
Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required):
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 Sunovion 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 computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sunovion 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.