Manager, Medical Writing - Innovative Medicine R&D (Remote, East Coast, USA)
Date: March 7, 2025
Location: West Chester, United States, Pennsylvania, 19380
Company: Teva Pharmaceuticals
Job Id: 59604
Who We Are:
Teva Pharmaceuticals is a global leader in making good health more accessible and affordable. Operating in nearly 60 countries, we are proud to be the world’s largest manufacturer of generic medicines, with many products listed on the World Health Organization's Essential Medicines List. Every day, 200 million people take one of our medicines. We continue to seek new ways to make a difference and invite new talent to join our journey.
The Opportunity:
As a Manager in Global Regulatory Medical Writing, you will be responsible for writing and editing high-quality clinical regulatory documents, including submission summaries and other complex materials essential for drug development and product registration. You will also provide guidance, oversee resources, and ensure seamless production of clinical research documentation that supports our mission to deliver innovative healthcare solutions.
How You’ll Spend Your Day:
Clinical Regulatory Document Writing & Editing:
Lead author for clinical regulatory documents, including:
Protocols
Clinical study reports
CTD Clinical Overview (M2.5) and Clinical Summaries (M2.7.1, M2.7.2, M2.7.3, M2.7.4)
ISS/ISE
Investigator brochures
Briefing documents
Responses to regulatory authority questions
Project Leadership & Accountability:
Work independently with minimal supervision.
Apply statistical and regulatory concepts in clinical document preparation.
Manage multiple documents simultaneously as the lead writer.
Provide strategic assistance and planning support for clinical regulatory documents.
Lead comment resolution meetings and guide the team toward successful outcomes.
Collaboration & Quality Assurance:
Collaborate with cross-functional teams to ensure timely delivery of high-quality documents.
Ensure documents adhere to applicable regulatory guidelines, departmental, and editorial standards.
Contribute to document template preparation and revisions to enhance efficiency.
Resource Management & Oversight:
May oversee contingent workers and/or vendors, offering training and resource management support.
Your Experience and Qualifications:
Education:
PhD or PharmD in Life Sciences (or a related field) or a Master’s degree in Life Sciences (or a related field).
Experience:
PhD or PharmD with at least 2 years of experience, or Master’s degree with at least 4 years of experience.
Preferred: 2-4 years of experience in regulatory medical writing.
Technical Skills:
Proficiency in Microsoft (MS) Word and advanced use of document preparation software, templates, and electronic formats.
Expertise in writing and editing clinical regulatory documents, including submission summaries and complex materials.
Strong knowledge of government regulations, global submission guidelines, and industry standards.
Familiarity with statistical concepts and regulatory requirements for document submission.
Other Requirements:
Demonstrated ability to contribute to strategy development and problem-solving.
Strong communication and collaboration skills to drive alignment and results.
Process development, improvement initiatives, and budget planning experience.
Compensation:
Annual Salary Range: $111,000 - $146,000 (dependent on geography, skills, education, experience, and other qualifications).
This position may also be eligible for a performance-based bonus.
Role Location:
US-Based Remote: Preference for Eastern Time Zone candidates.
Relocation Assistance and Work Visa Sponsorship Not Available.
Enjoy a More Rewarding Choice:
Teva offers a competitive benefits package, including:
Health Insurance: Medical, Dental, Vision, and Prescription coverage starting from day one.
Retirement Savings: 401(k) with 6% employer match and an annual 3.75% Defined Contribution.
Time Off: Paid Time Off (vacation, sick/safe time, caretaker time), 13 paid holidays, and 3 floating holidays.
Life & Disability Protection: Company-paid Life and Disability insurance.
Additional Benefits:
Employee Assistance Program
Employee Stock Purchase Plan
Tuition Assistance
Flexible Spending Accounts, Health Savings Account
Paid Parental Leave, Family Building Benefits, and more.
Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to providing equal employment opportunities regardless of age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national origin, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace.
Andra Pradesh :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Washington |Delaware :
Wilmington |Florida :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
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Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Hebron | Nebraska City |Nevada :
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Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
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Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Budapest |Istanbul :
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Brinny | Ringaskiddy |County Dublin :
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Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
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Dalian |Republic of China :
Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Amsterdam |Netherlands :
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Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Uxbridge | North York | Richmond Hill | Mississauga | Renfrew | Australia |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Netanya | Yavne | Tel Aviv | Be'Er Sheva | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
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Ciudad de México |New Zealand :
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Auckland |Lima Region :
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Warsaw |Remote :
Zaragoza | French | Manipal | Springville | Lenexa | Remote | Remote - South America (Latin Americal) | Leinster | McFarland | Xzagreb | Castlebar | Hammond | Tulsa | Blue Bell | Remote, USA | Slovakia | Faridabad | Texas | Lousiana | Switzerland | Belgium | Remote - Middle East | Remote - Africa | Bountiful | Riga | Ireland | Victoria | Minnesota | Bishop | Medan | Melbourne | Nairobi | Hungary | Green Way | Thailand | Remote - Europe |Bucharest :
Bucharest |Makkah :
Jeddah | Rabigh | Najran | King Abdullah Economic City | Riyadh | Khulais |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Sao paulo | Brazil |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |