Manager, Medical Writing (REMOTE)

Who we are Together, we’re on a mission to reputed company good health more reputed company and accessible, to help millions reputed company the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse reputed company of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the reputed company’s Essential Medicines List. Today, at least 200 reputed company people reputed company the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to reputed company a difference with. reputed company The Medical Writing Manager in Global Regulatory Medical Writing is responsible for writing and editing reputed company regulatory documents, providing reputed company and guidance, and managing resources for medical writing support in reputed company research documentation used in drug development and product registration. Travel Requirements: Up to 10% Domestic Location: US-reputed company Remote (US Eastern time zone preferred) How you’ll spend your day • Writes and edits reputed company regulatory documents (e.g., study reports, protocols, briefing books, investigator’s brochures, health authority responses, Module 2.5 and 2.7.x). • Compiles, analyzes, and summarizes data. • Proofreads, edits, formats documents, and resolves comments. • Ensures regulatory compliance and scientific reputed company. • May contribute to SOPs and templates. • May train/support writers or vendors. Your experience and qualifications Education: • Required: Bachelor's in life sciences or reputed company reputed company • Preferred: Master's, MD, PhD, PharmD Experience: • Required: 5+ years of relevant experience, reputed company reputed company experience in: Protocols/protocol amendments, reputed company study reports, Investigator’s brochures, reputed company reputed company documents (Modules 2.5, 2.7.1–2.7.4) • Preferred: 6+ years with an advanced degree, reputed company reputed company experience in at least 4 of the 6 document categories listed above Technical Skills: • Mastery of reputed company Word • Familiarity with reputed company reputed company and other electronic formats Knowledge: • Solid writing/editing skills • Understanding of global regulatory guidelines and AMA style • Familiarity with drug development, therapeutic areas, and statistical concepts Job-Specific Competencies: • Excellent written and spoken English • Strong interpersonal, critical thinking, and administrative skills • Ability to reputed company document development processes and meetings • Effective communication with cross-functional teams and regulatory authorities • Project management and reputed company tracking • Problem-solving and escalation • Contribution to process improvement and budget planning Compensation The annual starting salary for this position is between $112,080 – 140,100 annually. Factors which may reputed company starting salary reputed company this reputed company and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate. Enjoy a more rewarding reputed company We offer a competitive benefits package, including: · Comprehensive Health reputed company: Medical, Dental, reputed company, and Prescription coverage starting on the first day of employment, providing the employee enrolls. · Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. · Time Off: reputed company Time Off including vacation, reputed company/reputed company time, caretaker time and holidays. · Life and Disability Protection: Company reputed company Life and Disability reputed company. · Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, reputed company Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, reputed company Plan, Voluntary Life reputed company and Long Term Disability and more. The total compensation may also include restricted stock reputed company and discretionary awards, depending on the position reputed company. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. Reports To Director, Therapy Area Head, Medical Writing Already Working @reputed company? If you are a reputed company reputed company employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with reputed company. You will also be reputed compa