(Associate) Director, Medical Writing
2 weeks ago
Position Summary:We are seeking an experienced and highly motivated (Associate) Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal candidate will have deep experience in authoring and managing a wide range of regulatory and clinical documents, including clinical study protocols, clinical study reports (CSRs), Investigator's Brochures (IBs), Development Safety Update Reports (DSURs), and US regulatory submissions (e.g., INDs, FDA meeting packages).Key Responsibilities:Lead the planning, development, and delivery of clinical and regulatory documents in accordance with ICH guidelines, company SOPs, templates, and regulatory requirements.Author or oversee the writing of key documents including:Clinical Study Protocols and AmendmentsClinical Study Reports (CSRs)Investigator's Brochures (IBs)Development Safety Update Reports (DSURs)US IND modules (e.g., General Investigation Plan (GIP), Module 2, and other relevant sections)FDA briefing documents and meeting packagesEnsure documents are scientifically accurate, consistent, and aligned with regulatory strategy and messaging.Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and other departments to gather necessary information and align timelines.Provide strategic input to project teams on content, structure, and presentation of documents.Manage and mentor medical writers (in-house and/or contractors), ensuring high-quality deliverables and professional development.Support the development and maintenance of SOPs, templates, and style guides for medical writing practices.Participate in regulatory submission planning and contribute to project timelines.Assist in vendor selection and management for outsourced writing projects, ensuring quality and on-time delivery.Qualifications:Advanced degree in life sciences (PhD, PharmD, or MS preferred).Minimum of 8 years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.Proven experience authoring the following documents is required:Clinical study protocols and CSRsInvestigator's Brochures (IBs)DSURsIND submissions and FDA briefing documentsSolid understanding of global regulatory requirements (FDA, ICH, EMA).Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment.Excellent written and verbal communication skills.Proficiency in MS Word and document management systems; experience with electronic submission tools a plus.Ability to work independently as well as part of cross-functional teams.Experience mentoring or managing junior writers or external vendors preferred.Preferred Qualifications:Experience with global regulatory submissions (e.g., IND, CTA, NDA, MAA).Familiarity with electronic Common Technical Document (eCTD) format.Prior experience in degenerative diseases, rare diseases, or other therapeutic areas relevant to the company's pipeline.
-
(Associate) Director, Medical Writing
4 weeks ago
Waltham, United States Sironax Full timePosition Summary:We are seeking an experienced and highly motivated (Associate) Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal...
-
(Associate) Director, Medical Writing
3 weeks ago
Waltham, MA, United States Sironax Full timePosition Summary: We are seeking an experienced and highly motivated (Associate) Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal...
-
(Associate) Director, Medical Writing
3 weeks ago
Waltham, MA, United States Sironax Full timePosition Summary: We are seeking an experienced and highly motivated (Associate) Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal...
-
(Associate) Director, Medical Writing
3 weeks ago
Waltham, MA, United States Sironax Full timePosition Summary: We are seeking an experienced and highly motivated (Associate) Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal...
-
(Associate) Director, Medical Writing
2 weeks ago
Waltham, MA, United States Sironax Full timePosition Summary: We are seeking an experienced and highly motivated (Associate) Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal...
-
Director, Medical Writing Resourcing Group Lead
4 weeks ago
Waltham, United States CSL Plasma Inc. Full timeDirector, Medical Writing Resourcing Group Lead page is loaded## Director, Medical Writing Resourcing Group Leadlocations: Americas, US-PA, King of Prussia, CSL Behring: EMEA, CH, Kanton Zurich, Opfikon, CSL Vifor: EMEA, GB, Berkshire, Maidenhead, CSL Behring: Americas, US-MA, Waltham, CSL Behringtime type: Full timeposted on: Offerta pubblicata...
-
Hybrid Director, Medical Writing
3 weeks ago
Waltham, United States CSL Plasma Inc. Full timeA leading biopharmaceutical company located in Waltham, Massachusetts is seeking a Director of Medical Writing to manage a team and oversee the Medical Writing budget. The ideal candidate will bring 10+ years of experience in the biopharmaceutical industry, including leadership and budget management skills. This position involves strategic oversight of...
-
Waltham, United States CSL Full timeDescription Summary:You will be responsible for the provision of medical writing services to support clinical development by way of managing the Medical Writing budget project and functional budget, as well as ensuring the medical writing team is resourced appropriately to meet the demands of the portfolio.You are the key leadership role in the Clinical...
-
Medical Writing Consultant
3 weeks ago
Waltham, United States Stratacuity: Proven Scientific Placement Full timeMedical Writer – Oncology Clinical Trials Our Greater Boston area client is seeking an experienced Medical Writer with expertise in oncology clinical trials to support their growing clinical development programs. What You’ll Do Author and edit oncology trial documents (protocols, CSRs, IBs, IND/CTA sections, NDAs/BLAs). Collaborate with clinical,...
-
Waltham, United States Beacon Hill Full timeAssociate Director, Clinical Data Transparency and Disclosure Base pay range: $80.00/hr - $100.00/hr Location: Onsite 3 days per week in Waltham, MA The Associate Director, Clinical Data Transparency and Disclosure (DTD), is responsible for leading the global clinical trial transparency strategy and operations, ensuring compliance with all U.S. and...
