Director, Documentation Lead – Medical Writing

2+ years

Not Disclosed

India

10 Sept. 7, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Arvinas

Arvinas is a cutting-edge biotechnology company dedicated to transforming the lives of patients with severe and life-threatening diseases through the discovery, development, and commercialization of therapies that target disease-causing proteins for degradation. Leveraging our proprietary PROTAC® Discovery Engine, we engineer proteolysis-targeting chimeras (PROTAC® targeted protein degraders) to utilize the body’s natural protein disposal system, effectively removing harmful proteins and advancing patient care.

Our pipeline includes several promising investigational drugs, such as:

Vepdegestrant: Targeting the estrogen receptor for patients with ER+/HER2- locally advanced or metastatic breast cancer.
ARV-102: Targeting LRRK2 for neurodegenerative disorders.
ARV-393: Targeting BCL6 for relapsed/refractory non-Hodgkin lymphoma.

In April 2024, Arvinas entered a significant agreement with Novartis, securing a global license for the clinical-stage PROTAC® androgen receptor protein degrader ARV-766, aimed at treating prostate cancer. This deal was finalized in May 2024.

Our team, known as #TeamArvinas, comprises about 450 dedicated professionals who thrive in an environment that values innovation, creativity, and community engagement. We are driven by our mission to enhance the lives of patients with serious diseases using our groundbreaking PROTAC® platform. We invite you to explore more about life at Arvinas and hear directly from our employees.

Position Summary

Arvinas is seeking a Director, Documentation Lead in Medical Writing to manage and develop medical writing deliverables for our R&D portfolio. This role involves overseeing global submissions, ensuring document consistency, assigning resources, and mentoring writing staff. You will act as a liaison among key functions, preparing and updating critical documents such as clinical protocols, annual reports, Investigator Brochures, abstracts, clinical study reports, and regulatory authority briefing materials.

This role reports to the Senior Director of Medical Writing, Clinical Operations, and can be performed remotely, in a hybrid setting, or at our headquarters in New Haven, CT.

Principal Responsibilities

Leadership:

Lead as Program/Submission Lead, developing strategic plans and managing projects for regulatory submissions and clinical deliverables.
Utilize extensive knowledge of regulatory medical writing and therapeutic areas to support pipeline projects.
Represent the medical writing function in cross-functional teams and apply regulatory/compliance/scientific requirements.
Ensure timely and high-quality documentation production, and solve complex medical writing challenges.

Medical Writing:

Master complex writing tasks, including Phase 3 CSRs, SCS, SCE, and regulatory meeting packages.
Coordinate and author key regulatory documents, integrating scientific, medical, and regulatory insights.
Manage timelines and deliverables for all assigned documents, and oversee quality control reviews.

Supervising and Maintaining Standards:

Provide guidance on medical writing processes and standards.
Supervise and mentor medical writers and contractors.
Lead the development of document prototypes and templates.

Qualifications

10+ years in the research, medical, pharmaceutical, or biotechnology industry.
Minimum of 3 years in a supervisory role leading medical writers.
At least 5 years of experience preparing regulated documents in the pharmaceutical or biotech industry, with a focus on oncology or rare diseases.
Excellent oral and written communication, presentation, and project management skills.
Ability to thrive in a fast-paced, entrepreneurial environment with a strong sense of urgency.
In-depth understanding of global drug development and regulatory submission requirements.
Proven writing skills, evidenced by high-quality regulatory documentation or peer-reviewed publications.
Proficiency in Microsoft Office, Adobe Acrobat, document management systems, and SharePoint.
Strong interpersonal skills to foster a collaborative team environment.

Education

Bachelor’s Degree required; Advanced Degree preferred.

Additional Information

This role does not offer VISA sponsorship now or in the future.
The position is generally performed in a home office environment. Candidates must be able to use a computer, communicate via phone and electronic messaging, and collaborate effectively.

Benefits

Arvinas offers a competitive base salary, incentive compensation, and a comprehensive benefits package including medical, vision, dental coverage, life insurance, and more. To learn more about Arvinas and explore our opportunities, please visit www.arvinas.com.

Arvinas is an Equal Opportunity Employer.

Latest Jobs

Biostatistical Programming Senior Associate

Amgen

Hyderabad

Senior Specialist, Icsr Management

Gsk Plc

Bengaluru India

Manager, Drug Safety Physician, Pharmacovigilance, Epidemiology & Risk Management

Cencora

India

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Brazil | Sao paulo |

Attica :

Athens | Koropi |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

South Africa :

Midrand | South Africa |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Director, Documentation Lead – Medical Writing

Job Description

Latest Jobs

Biostatistical Programming Senior Associate

Senior Specialist, Icsr Management

Manager, Drug Safety Physician, Pharmacovigilance, Epidemiology & Risk Management

Senior Associate, Pharmacovigilance - Us - Remote

Graduate Pharmacovigilance Associate

Graduate Pharmacovigilance Associate

Senior Pharmacovigilance Associate Post-Marketing (Fsp - Sponsor Dedicated)

Pharmacovigilance Associate Post-Marketing (Fsp - Sponsor Dedicated)

Graduate Pharmacovigilance Associate

Manager – Heor Modeling

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England