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Manager, Medical Writing (REMOTE) Job at Tevapharm in Baltimore

Manager, Medical Writing (REMOTE) Job at Tevapharm in Baltimore

MediabistroBaltimore, MD, United States
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Who we are

Together, we’re on a mission to make good health more affordable 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 variety 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 World Health Organization’s Essential Medicines List. Today, at least 200 million 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 make a difference with.

The opportunity

The Medical Writing Manager in Global Regulatory Medical Writing is responsible for writing and editing clinical regulatory documents, providing oversight and guidance, and managing resources for medical writing support in clinical research documentation used in drug development and product registration.

Travel Requirements : Up to 10% Domestic

Location : US-Based Remote (US Eastern time zone preferred)

How you’ll spend your day

  • 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).
  • Compiles, analyzes, and summarizes data.
  • Proofreads, edits, formats documents, and resolves comments.
  • Ensures regulatory compliance and scientific clarity.
  • May contribute to SOPs and templates.
  • May train / support writers or vendors.

Your experience and qualifications

Education :

  • Required : Bachelor\u2019s in life sciences or related field
  • Preferred : Master\u2019s, MD, PhD, PharmD
  • Experience :

  • Required : 5+ years of relevant experience, Lead author experience in : Protocols / protocol amendments, Clinical study reports, Investigator’s brochures, Clinical summary documents (Modules 2.5, 2.7.1–2.7.4)
  • Preferred : 6+ years with an advanced degree, Lead author experience in at least 4 of the 6 document categories listed above
  • Technical Skills :

  • Mastery of Microsoft Word
  • Familiarity with Veeva Vault and other electronic formats
  • Knowledge :

  • Understanding of global regulatory guidelines and AMA style
  • Familiarity with drug development, therapeutic areas, and statistical concepts
  • Excellent written and spoken English
  • Strong interpersonal, critical thinking, and administrative skills
  • Ability to lead document development processes and meetings
  • Effective communication with cross-functional teams and regulatory authorities
  • Project management and timeline 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 affect starting salary within this range and level of role may include geography / market, skills, education, experience and other qualifications of the successful candidate.

    Enjoy a more rewarding choice

    We offer a competitive benefits package, including :

  • Comprehensive Health Insurance : Medical, Dental, Vision, 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 : Paid Time Off including vacation, sick / safe time, caretaker time and holidays.
  • Life and Disability Protection : Company paid Life and Disability insurance.
  • 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, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
  • The total compensation may also include restricted stock units 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.

    Reports To

    Director, Therapy Area Head, Medical Writing

    Already Working @TEVA?

    If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply : Internal Career Site

    The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR / IT partner.

    Teva’s Equal Employment Opportunity Commitment

    Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all.

    If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All 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.

    Important notice to Employment Agencies - Please Read Carefully

    Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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    Medical Writing Job • Baltimore, MD, United States

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