(+45) 29 44 00 80 / kontakt@beirholmsearch.dk

Senior Medical Writer

Senior Medical Writer
maj 13, 2020 Hanne Beirholm
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….looking for a highly motivated, independent and talented Senior Medical Writer


Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role
We are looking for a highly motivated, independent and talented Senior Medical Writer with a minimum of 5 years’ relevant medical or scientific writing experience in the Pharmaceutical Industry (oncology experience preferred, but not required if the candidate has demonstrated experience in other indication[s]).
As Senior Medical Writer, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As Senior Medical Writer, you will be responsible for ensuring that scientifically robust messages and arguments are developed and conveyed consistency across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.
Key Responsibilities
• Draft and edit documents used to support clinical trial conduct and reporting, including clinical trial protocols, investigator’s brochures, and clinical study reports. Additionally, draft and edit Health Authority briefing packages, Health Authority responses, and clinical CTD submission documents.
• Drive trial team participation in the preparation of such documents, including calling/scheduling/facilitating meetings, developing and managing timelines, document review, and decisions.
• Provide peer review and editing support for other clinical/regulatory documents, as needed.
• Adhere to guidelines, SOPs, and practices and technical and industry standards during all aspects of work.
• Support developing and reviewing standard processes and templates.
• Work effectively in cross-functional working groups.
Requirements
• You hold a MSc degree or equivalent in a relevant life science subject
• At least 5 years’ experience as a clinical or regulatory medical writer in the pharmaceutical industry, preferably within oncology.
• Experience authoring clinical components in regulatory filings (NDA, BLA, MAA) highly preferred.
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, EndNote, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
• Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses.  Experience with Paediatric Investigational Plans (PIPs) is preferred.
• General understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize tabular and graphical data presentations.
Moreover, you meet the following personal requirements:
• You are capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.
• You are motivated and detail-oriented.
• You have the ability to work across all trial phases and prioritize your own tasks.
• You have a quality mindset and thrive in a fast-paced and changing environment.
• You are a dedicated team player and a great communicator with excellent oral and written communication skills.
• You are proactive and open-minded with a goal-orientated and committed to contributing to the overall success of Genmab.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a temporary employment agreement and a contract for indefinite time after two years of employment regardless of seniority.
Genmab A/S is committed to protecting your personal data and privacy. Through the web site Genmab A/S obtains certain personally identifiable information provided by you voluntarily.
The personally identifiable information is the information you provide to Genmab A/S when signing up for Genmab A/S’s News Alert, Genmab A/S’ Event Alert, logging on to Genmab A/S’s Investor Portal or mailing to Genmab A/S regarding general or business inquiries or with web site feedback. The personally identifiable information will only be used to provide the services requested by you and to improve our services to you as described in our Privacy Policies.
Application and further information:
If you would like additional information about this position before applying using the link, please contact Hanne Beirholm, Beirholm Search. Tel. +4529440080 /mail: kontakt@beirholmsearch.dk




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