Associate Director, Medical Writing

Sunovion Pharmaceuticals is looking for an Associate Director, Medical Writing to join our Medical Writing, Global Regulatory Affairs team.
An Associate Director, Medical Writing develops strategic Medical Writing plans in order to meet clinical program objectives. An Associate Director, Medical Writing provides resource estimates and guidance and oversees Medical Writing staff to ensure regulatory submission documents are developed in accordance with Medical Writing plans. An Associate Director, Medical Writing is accountable for the timely delivery of high quality regulatory submission documents. An Associate Director, Medical Writing will lead the Medical Writing activities for one or more therapeutic areas or clinical development programs.
Essential Functions

• Develop strategic Medical Writing plans to support the clinical development lifecycle and program goals for one or more clinical development programs (30%).
• Determine resource requirements to meet regulatory submission document deliverable milestones and timelines in accordance with Medical Writing plans (10%)
• Manage and provide expert mentorship and guidance to Medical Writing staff (internal/external) to ensure document development activities are performed in accordance with Medical Writing plans (20%)
• Provide senior level review of 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 (20%).
• Develop regulatory submission documents (eg, clinical protocols, clinical study reports, investigator brochures, and clinical sections of investigational new drug (IND) and new drug applications (NDA) (10%).
• Develop and maintain Medical Writing standard operating procedures and contribute to organizational process improvements (10%).

Minimum Education, Experience, Knowledge and Skills Required:

• Bachelor's degree required; advanced degree (Master's or Ph.D) in science desired.
• 5 to 7 years Medical Writing experience.
• Minimum of 2 years management of Medical Writing staff (internal/external).
• Process development and improvement.
• 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.

The base salary hiring range for this position is expected to be $150,000.00 to $205,000.00 annually. The base salary offered is negotiable and potentially exceeds the hiring range depending on factors such as the candidate's relevant knowledge, skills, training, certifications and industry-based experience for the role. Our total rewards package also includes the opportunity for merit-based salary increases, short and long-term incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Our robust time-off policy includes accrual of 15 vacation days in first year, 13 paid holidays plus additional time off for a shut-down period during the last week of December, access to sick time, tuition reimbursement and our recognition program.
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Health and Safety: To maintain the health and safety of our employees, patients, and affiliates, as well as comply with the vaccination requirements of our partners, employees are required to be vaccinated against COVID -19. Candidates hired must provide proof of vaccination against COVID-19 within 5 days post hire as a condition of employment. In accordance with Equal Employment Opportunity laws, exemptions for religious and medical reasons will be considered.
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 personal 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.
For more information about EEO and the Law, please visit the following pages:
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