- Responsible for managing the MW department budget, strategic planning, and overall operating strategy for the MW department.
- Responsible for ensuring the MW department is adequately staffed to support all corporate objectives.
- Collaborate cross-functionally to oversee the preparation of protocol synopses, protocols, protocol amendments/addenda, study reports, investigator brochures, annual safety reports, IND/IMPD clinical sections, Module 2 summaries, briefing books, regulatory responses, and other documents as necessary in CTD format under strict timelines.
- Responsible for inspection readiness activities for the MW group.
- Responsible for Apellis's editorial standards and style guide. Oversee efficient formatting of documents, ensure a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier.
- Responsible for the data verification/quality review process for documents developed by the MW team.
- Oversee overall project management of document timelines for cross functional working groups to facilitate efficient development and finalization of clinical, regulatory, and safety documents for submissions.
- Oversee management, professional development, training, and performance of all MW staff.
- Oversee the document publishing group to facilitate publishing of clinical, nonclinical, and CMC documents and an efficient hand-off to the regulatory submissions group.
- Manage the MW vendor selection process and maintain regular communication with selected vendors.
- Point of escalation of issues related to the document development process.
- Other duties and responsibilities, as required.
- 12+ years' experience in a medical writing capacity within the pharmaceutical/biotechnical environment (or equivalent experience).
- Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, regulatory, and medical terminology preferred.
- Detailed knowledge of the requirements for preparation of key clinical, nonclinical, and regulatory documents for INDs, CTAs, BLAs, and annual reports preferred.
- Experience in rare disease and/or ophthalmology preferred.
- Experience in a start-up environment preferred.
- Experience managing and mentoring employees preferred.
- Comfortable with ambiguity and resilient in the context of a rapidly changing, highly innovative environment.
- Highly collaborative with strong problem-solving skills.
- This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
- Up to 20% travel expected.
-
Director, Medical Writing
1 week ago
Bicycle Therapeutics Cambridge, United StatesBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small mole ...
-
Head of Medical Writing
3 weeks ago
Aerovate Therapeutics, Inc. Waltham, United StatesAerovate (AVTE) is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of people with rare cardiopulmonary disease. Our team has spent their careers in cardiopulmonary disease research, drug and aerosol development, commercia ...
-
Manager Medical Writing
2 days ago
9992 Cambridge, United StatesJob Description · Job DescriptionSupervise regulatory writing vendors to manage submission documents and ensure the science-supported clinical messaging is clear and concise and is fully aligned with program team strategy. · Collaborate with cross functional teams providing time ...
-
Medical Writing Contractor
2 days ago
The Steely Group Cambridge, United States FreelanceJob Description · Job DescriptionOur client is looking for someone to supervise regulatory writing vendors to manage submission documents and ensure the science-supported clinical messaging is clear and concise and is fully aligned with program team strategy. · Collaborate with c ...
-
Manager Medical Writing
2 days ago
The Fountain Group Cambridge, United StatesJob Description · Job DescriptionHello, my name is Thomas Gillitzer and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Medical Writing Consultant for a prominent client of ours. Details for the position are as follows ...
-
Director, Regulatory and Medical Writing
3 weeks ago
BioSpace Cambridge, United StatesJob Details · About the role · Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director, Regulatory and M ...
-
Senior/Executive Director, Medical Writing
1 week ago
Zenas BioPharma Waltham, United StatesZenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global ...
-
Director of Medical Writing
3 days ago
Department Of Transportation Cambridge, MA, United StatesDutiesVolpe's Director must be an experienced manager, who understands how Volpe can help USDOT achieve its goals with strong Senior Executive level interpersonal skills, able to forge strong working relationships. The Director needs strong leadership and management skills and th ...
-
Associate Director, Medical Writing
3 weeks ago
Moderna, Inc. Cambridge, United States Full timeThe Role: · The Associate Director of Medical Writing is an incredible opportunity to work under the direct mentorship of our Director or Senior Director of Medical Writing. The chosen candidate will not just be a part of Modernas medical writing team but will lead the charge in ...
-
Sr. Manager, Medical Writing
17 hours ago
Moderna, Inc. Cambridge, United States Full timeThe Role: · The Senior Manager of Medical Writing Delivery & Excellence is a high-impact role that demands a dynamic blend of expertise in both traditional medical writing and technological innovation. Reporting directly to the Senior Director of Medical Writing Delivery & Excell ...
-
Sr. Manager, Medical Writing
3 weeks ago
Moderna, Inc. Cambridge, United States Full timeThe Role: · The Senior Manager of Medical Writing is a high-impact role, reporting directly to the Associate Director, Director of Medical Writing, or Senior Director of Medical Writing. The chosen individual will not just be responsible for, but will excel in delivering high-qua ...
-
Director, Regulatory and Medical Writing
4 weeks ago
Sana Biotechnology Cambridge, United States Full timeAbout the role · Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director, Regulatory and Medical Writing ...
-
Executive Director, Medical Writing
3 weeks ago
MapLight Therapeutics, Inc. Burlington, United StatesWho We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets a ...
-
Manager, Medical Writing
4 hours ago
Pfizer Groton, United StatesROLE SUMMARY- · - Understands the principles of scientific writing, writing with the audience in mind, and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create documents.- Applies comprehensive knowledge of rele ...
-
Associate Director, Medical Writing
1 week ago
Entrada Therapeutics Boston, United States Full timeThe Organization · What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. · O ...
-
Synterex Dedham, United StatesSynterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accur ...
-
Synterex Dedham, United StatesJob Description · Job DescriptionSalary: · Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, wit ...
-
Senior Manager, Publications
1 week ago
CSL Behring Waltham, United States Full timeThe Opportunity: · The Senior Manager, Publications is responsible for the coordination, implementation, and execution of the medical publication plan. You will manage the medical writing vendors in the daily activities of writing and tracking our key scientific materials includi ...
-
Senior Manager, Publications
3 weeks ago
CSL Seqirus North Waltham, United StatesThe Opportunity: · The Senior Manager, Publications is responsible for the coordination, implementation, and execution of the medical publication plan. You will manage the medical writing vendors in the daily activities of writing and tracking our key scientific materials includi ...
-
Medical Interpreter II, Portuguese
2 weeks ago
Boston Children's Hospital Waltham, United States Full timeJob Summary · At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. It's in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have ...
Senior Director, Medical Writing - Waltham, United States - Apellis
Description
Job Description
Job DescriptionPosition Summary:
Apellis is seeking a Senior Director, Medical Writing (MW) to lead the MW, editing, and clinical publishing groups in support of a variety of regulatory areas including CMC and non-clinical, but primarily clinical. This role reports directly to the SVP, Development Operations.
Key Responsibilities Include:
Education, Registration & Certification:
Kills, Knowledge & Abilities:
Physical Demands and Work Environment:
Travel Requirements:
Benefits and Perks:
Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more Visit to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit or follow us on Twitter and LinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
