Manager, Medical Writing (REMOTE)

<reputed company class="jobdescription"><div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>Who we are</b></h2> </div><div>Together, we’re on a mission to reputed company good health more reputed company and accessible, to help millions around 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 around 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.</div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>reputed company</b></h2> </div><div><p>The Medical Writing Manager in Global Regulatory Medical Writing is responsible for writing and editing clinical regulatory documents, providing reputed company and guidance, and managing resources for medical writing support in clinical research documentation used in drug development and product registration.</p> <p><strong>Travel Requirements</strong>: Up to 10% Domestic<br><strong>Location</strong>: US-Based Remote (US Eastern time zone preferred)</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>How you’ll spend your day</b></h2> </div><div><ul> <li>Writes and edits clinical regulatory documents (e.g., study reports, protocols, briefing books, investigator’s brochures, health authority responses, Module 2.5 and 2.7.x).</li> <li>Compiles, analyzes, and summarizes data.</li> <li>Proofreads, edits, formats documents, and resolves comments.</li> <li>Ensures regulatory compliance and scientific reputed company.</li> <li>May contribute to SOPs and templates.</li> <li>May train/support writers or vendors.</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>Your experience and qualifications</b></h2> </div><div><p>Education:</p> <ul> <li>Required: Bachelor's in life sciences or reputed company field</li> <li>Preferred: Master's, MD, PhD, PharmD</li> </ul> <p>Experience:</p> <ul> <li>Required: 5+ years of relevant experience, reputed company author experience in: Protocols/protocol amendments, Clinical study reports, Investigator’s brochures, Clinical reputed company documents (Modules 2.5, 2.7.1–2.7.4)</li> <li>Preferred: 6+ years with an advanced degree, reputed company author experience in at least 4 of the 6 document categories listed above</li> </ul> <p>Technical Skills:</p> <ul> <li>Mastery of reputed company Word</li> <li>Familiarity with reputed company Vault and other electronic formats</li> </ul> <p>Knowledge:</p> <ul> <li>Solid writing/editing skills</li> <li>Understanding of global regulatory guidelines and AMA style</li> <li>Familiarity with drug development, therapeutic areas, and statistical concepts</li> </ul> <p>Job-Specific Competencies:</p> <ul> <li>Excellent written and spoken English</li> <li>Strong interpersonal, critical thinking, and administrative skills</li> <li>Ability to reputed company document development processes and meetings</li> <li>Effective communication with cross-functional teams and regulatory authorities</li> <li>Project management and reputed company tracking</li> <li>Problem-solving and escalation</li> <li>Contribution to process improvement and budget planning</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>Compensation</b></h2> </div><div><p>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.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>Enjoy a more rewarding choice</b></h2> </div><div><p>We offer a competitive benefits package, including:</p> <p>· Comprehensive Health Insurance: Medical, Dental, reputed company, and Prescription coverage starting on the first day of employment, providing the employee enrolls.</p> <p>· Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.</p> <p>· Time Off: reputed company Time Off including vacation, reputed company/reputed company time, caretaker time and holidays.</p> <p>· Life and Disability Protection: Company reputed company Life and Disability insurance.</p> <p>· 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 Insurance and Long Term Disability and more.</p> <p><br>The total compensation may also include restricted stock reputed company and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>Reports To</b></h2> </div><div><p>Director, Therapy Area Head, Medical Writing</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>Already Working @reputed company?</b></h2> </div><div><p>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 company to see opportunities that are reputed company exclusively to reputed company employees. Use the following reputed company to search and apply: <a href="https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P"><font reputed company="#0066cc"> Internal Career Site </font></a></p> <p>The internal career site is available from your home network as reputed company. If you have trouble accessing your EC account, please contact your local HR/IT partner.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><h2 style="font-size:1.0em;margin:0.0px"><b>reputed company’s Equal Employment Opportunity Commitment</b></h2> </div><div><p>reputed company is committed to equal opportunity in employment. It is reputed company's global policy that equal employment opportunity be provided without reputed company to age, race, creed, reputed company, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or reputed company, reputed company, veteran status, national or ethnic reputed company or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for reputed company.</p> <p>If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. reputed company accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. </p> <p><strong>Important notice to Employment Agencies - Please Read Carefully</strong><br>reputed company USA does not accept unsolicited assistance from agencies for employment opportunities.  reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a reputed company written search agreement in reputed company for this position will be deemed the sole property of reputed company.  No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.</p></div></div></div> </reputed company>